News

RIPPLE-ABBVIE OPHTHALMIC DRUG DELIVERY PANEL

Thu, 12 Feb 2026 21:56:37 GMT

Our Chief Technology Officer, Wendy Naimark , was pleased to be speaking with AbbVie Directors, Allison Hoch, PhD, MBA, Director of Global Alliances and Amy Hopkin Director of Search & Evaluation for AbbVie Eyecare, on a Harnessing Innovation & Collaboration to Accelerate Ophthalmic Drug Delivery Panel at the 4th Annual Ophthalmic Drug Delivery Summit on Thursday January 29th in San Francisco, CA.

��️ Topic: Unlocking Biotech-Pharma Collaboration: How Agile Small Teams & Experienced Pharma Combine Strengths to Accelerate Innovation & Deliver Real-World Impact.

Areas Covered:
✅ Co-developing platforms, managing device timelines and regulatory alignment in combo products
✅ Leveraging the speed and innovation of biotech startups with deep experience and resources of pharma
✅ Continuous learning through cooperation during diligence, development planning and execution phases
✅ The importance of proactive, transparent communication across functions to anticipate challenges and optimize for success

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Ripple Therapeutics Enters Collaboration with Bausch + Lomb

Tue, 25 Nov 2025 13:28:00 GMT

TORONTO, CANADA / November 25, 2025 - Ripple Therapeutics Corporation, a clinical stage company focused on improving ophthalmic therapeutics with controllable sustained delivery implants, is pleased to announce that, earlier this year, it entered into an evaluation program and licensing option agreement with an affiliate of Bausch + Lomb Corporation (NYSE/TSX: BLCO), a leading global eye health company dedicated to helping people see better to live better.

Ripple’s patented technology platform is based on a discovery that drugs can be chemically engineered into controlled release pharmaceuticals without the use of polymers. These proprietary prodrugs undergo surface erosion to give zero order release kinetics and are highly engineerable to tailor both drug dose and duration. Because there are no polymers, once the drug is gone, the implant is gone with no pro-inflammatory degradation products.

“We’ve known the team at Ripple for a number of years and have always been impressed with their technology platform,” commented Mayssa Attar, PhD, SVP Pharmaceutical and Consumer R&D Head. “We are pleased to be working with them on this innovative approach to sustained drug delivery which has the potential to improve upon the current standard of care for ophthalmic diseases.”

“We’re pleased to partner with Bausch + Lomb and look forward to working with them to develop sustained release implants that will benefit patients with extended duration and improved safety,” commented Tom Reeves, President & CEO, Ripple Therapeutics. “This is our third strategic collaboration transaction in the last 12 months, which we believe is a testament to the power of the Ripple technology platform and the breadth of its application.”

Under the terms of the agreement, Bausch + Lomb will fund the early-stage feasibility and preclinical evaluation of the target molecule and will have the option to license any formulations being evaluated under the program for additional financial consideration including milestones and royalties.

About Ripple Therapeutics

Ripple Therapeutics Corporation is a privately held clinical stage company focused on improving ophthalmic therapeutics with controllable sustained delivery implants without the use of polymers. Our novel therapeutics provide better outcomes for patients, easier management of care for physicians and lower cost for payors. www.rippletherapeutics.com

Media Contact (Ripple)

Julie Fotheringham, V.P. Marketing, People & Culture, Ripple Therapeutics

M: 416-951-7988 E: jfotheringham@rippletherapeutics.com

Overview of the Epidel® Prodrug Engineered Sustained Drug Delivery Platform
Wendy Naimark, CTO & Co-Founder

Mon, 24 Nov 2025 13:28:05 GMT

Co-Founder and Chief Technology Officer, Wendy Naimark, PhD., recently presented “Overview of the Epidel Prodrug Engineered Sustained Drug Delivery Platform” at PODD: Partnership Opportunities in Drug Delivery.

Click to View

OIS XV

Mon, 24 Nov 2025 13:28:03 GMT

Co-Founder, President & CEO, Tom Reeves, presented at Ophthalmology Innovation Source in San Diego.

OIS Ignite on November 20, 2025 (Power Partnerships: Alliances that Accelerate Innovation)
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OIS XV on November 22, 2025 (Retina Innovation Showcase)

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Why a Homegrown Biotech Sector Matters for Canada

Wed, 22 Oct 2025 13:53:15 GMT

Canadian Business

Wendy Naimark, October 20, 2025

https://canadianbusiness.com/sponsored/why-a-homegrown-biotech-sector-matters/

Canada has the talent and innovation to lead in biotech, but without stronger investment, breakthroughs risk leaving our borders.

I’m a Canadian-born scientist and I earned my Ph.D. in Biomaterials at the University of Toronto—and yet I never expected to launch a biotech company here.

Thirty years ago, I moved to the United States to pursue opportunities in the biotech sector. Canada has an incredible legacy of biotech innovation, from developing insulin to the nanoparticles that deliver mRNA vaccines. But back in the ‘90s when I left, we didn’t have the tech incubators nor did we encourage a product development mindset as we do today.

Proudly, we’ve come a long way since then. Today we have the fifth-largest startup ecosystem in the world, according to the Global Startup Ecosystem Index. There are more than 50,000 startups in Canada and last year, they raised $1.3 billion in Q3 alone.

Even so, just a few years ago, I would have told you I had no plans to leave my job in Boston. But then came the opportunity to head up the drug delivery team at Interface Biologics (IBI), an innovative material science company which was founded on discoveries from Professor Paul Santerre’s labs at U of T and one of the initial tenants at the MaRS Discovery District in downtown Toronto.

A breakthrough for patients with eye disease

Back when I was in grad school, I frequently walked past the corner of College and University—what was then Toronto General Hospital and the Heritage Building—never imagining it would one day become a vibrant tech hub. Then in 2013, I was back for a visit and drove past that same corner. Seeing MaRS for the first time, I immediately thought, “Wow, I’d love to work there someday.”

That dream came true with the opportunity to join IBI in 2016. And that’s just the start of the story.

In 2020, after selling the majority of IBI to a German chemical company, my colleagues and I spun out the drug delivery part of IBI and founded Ripple Therapeutics.

Ripple is a clinical-stage biotech company with a focus on ophthalmology. Our technology is based on a discovery that drugs can be designed to deliver themselves over an extended period of time by using a small amount of chemical engineering. We do this without polymers which enables drugs to be made into tiny implants that undergo slow, sustained release, sort of like a bar of soap dissolving over time. Many diseases of the eye require frequent drops or injections, which is a burden for patients and often results in low treatment compliance. With our technology, we’re aiming for six to 12 months of sustained treatment delivery with one injection.

To give an example, one patient in our recently completed Phase 2 trial has a disease called diabetic macular edema. For the prior nine years she had been receiving injections every two months. She enrolled in our trial and had one injection of our slow releasing dexamethasone implant and then went eight months before she had to be retreated. For her, that was a fantastic quality of life improvement.

If this sounds like a success story, imagine delivering these improvements at scale.

That’s our goal. But it’s also our greatest struggle.

The “missing middle”

There is no doubt Canada has become a powerhouse when it comes to developing groundbreaking scientific innovations. But we are struggling to truly deliver on their promise because we are struggling with the next step: commercialization.

I can’t think of a better place to continue growing Ripple. During my time at MaRS, I’ve enjoyed more than the stunning building that caught my attention back in 2013. I’ve found an incredible community of passionate scientists and multi-disciplinary experts, all focused, just like me, on conceiving and delivering breakthroughs that change lives. There’s a sense of collaboration and cross-pollination that boosts us all. For example, Ripple has benefited from MaRS tenant connections including equipment sharing with our South Tower third floor neighbour Cohesys, idea-sharing with our Atuka colleagues on the first-floor and through MaRS conferences like the Accelerate Conference where we connected with the Acceleration Consortium Self-Driving Lab on the South Tower 6th floor.

But to deliver on all this potential en masse, biotech companies like ours must navigate a series of clinical trials. A Phase 2 trial, such as the one we’ve completed, typically includes fewer than 100 patients. Phase 3 trials randomize typically more than 500 patients, so you can imagine the additional complexity and cost.

Made-in-Canada breakthroughs like ours are at risk because we lack the investment and infrastructure to support that “missing middle” and to help companies take their solutions from the lab into the real world.

Raising equity dollars from Canadian sources continues to be one of the biggest challenges for early-stage biotech companies like Ripple. At Ripple, we’ve been successful in raising over $65M USD. But only $15M has been equity, the rest through partnership project payments and non-dilutive funding.

To take the next steps, we need to create investment infrastructure, just as other countries have.

Creating a sustainable Canadian biotech ecosystem

What’s at stake if we don’t increase our support for Canadian biotech?

Just consider what happened with insulin, which was famously invented just a stone’s throw away from MaRS by Dr. Frederick Banting and Charles Best. Over time, the rights to produce this lifesaving drug were sold to Scandinavia and parlayed into the founding of Novo Nordisk. The benefits to Denmark have been enormous: last year, Novo Nordisk’s market value was $570-billion, and in 2023, the company contributed approximately $3-billion in taxes. Furthermore, the pharmaceutical industry is one of the greatest contributors to Denmark’s GDP.

But it’s not just about leaving money on the table.

In this “elbows up” moment, we need to expand our thinking beyond choosing Canadian at the grocery store or the fuel pumps and invest in biotech. There’s a practical benefit to this for Canadians—for example, think back to Covid-19 when we didn’t have the systems in place to make our own vaccines. Consider how attractive a profitable and dynamic biotech pipeline is to global talent.

Simply put, Canada’s biotech ecosystem is on the line. Without connecting companies like ours to the investment capital and infrastructure we need, we risk losing all this potential. Instead of taking companies to the next level here, we risk continuing down the path of forcing biotechs to take their breakthroughs—and all the benefits that come with this innovation—elsewhere.

As we focus on supporting Canada, let’s not forget about biotech. Prime Minister Mark Carney’s Canada Strong plan calls out that “it’s time to be ambitious, to invest in high-potential companies, to make sure that Canada is where the best and the brightest want to be.”

This is a unique time in Canada’s history indeed, and to truly capture this momentum, it’s time to bet on Canadian biotech. We simply can’t afford not to.

Ripple is featured in LSO’s Success Stories

Thu, 05 Dec 2024 14:31:36 GMT

Ripple is featured (page 48) in LSO’s Success Stories publication, celebrating the groundbreaking work and inspiring contributions of Ontario’s life sciences organizations.

View Presentation

Ripple Therapeutics Announces Evaluation and Licensing Agreements with Glaukos

Tue, 15 Oct 2024 12:31:52 GMT

TORONTO, CANADA / ACCESSWIRE / October 15, 2024 - Ripple Therapeutics Corporation, a clinical stage company focused on improving ophthalmic therapeutics with controllable sustained delivery implants, is pleased to announce evaluation and licensing agreements with Glaukos Corporation (NYSE: GKOS), an ophthalmic pharmaceutical and medical technology company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal disease.

Ripple’s patented technology platform is based on a discovery that drugs can be chemically engineered into controlled release pharmaceuticals without the use of polymers or excipients. These proprietary prodrugs undergo surface erosion to give zero order release kinetics and are highly engineerable to tailor both drug dose and duration. The advantages of this technology include lower molecular weight and higher drug loading allowing for smaller implants and a lack of degradation products which provides both a clearer regulatory path as well as an improved safety profile. With an extended duration of therapeutic benefit, this technology will also reduce the treatment burden for patients. These agreements enable Glaukos to leverage Ripple’s proprietary technology platform to create sustained release implants of targeted APIs for both glaucoma and retinal diseases. If the program is successful, the evaluation agreement will automatically convert into a licensing agreement with future milestone payments and royalties.

“We believe Ripple has one of the most promising drug delivery technologies currently under development,” commented Tomas Navratil, PhD, Chief Development Officer, Glaukos. “We are pleased with the progress of our collaboration and have enjoyed working with the Ripple team as we work together to bring these much-needed sustained release products to patients with critical unmet needs.”

“This is the first of what we believe will be a number of transactions using our technology platform in concert with partners’ APIs to create sustained release implants which will benefit patients with extended duration and improved safety”, commented Tom Reeves, President & CEO, Ripple Therapeutics. “We look forward to continued collaboration with the entire Glaukos team.”

About Ripple Therapeutics

Ripple Therapeutics Corporation is a privately held clinical stage company focused on improving ophthalmic therapeutics with controllable sustained delivery implants. Ripple’s patented technology platform is based on a discovery that drugs can be chemically engineered into controlled release pharmaceuticals without the use of polymers or excipients. These proprietary prodrugs undergo surface erosion to give zero order release kinetics and are highly engineerable to tailor both drug dose and duration. The advantages of this technology include lower molecular weight and higher drug loading allowing for smaller implants and a lack of degradation products which provides both a clearer regulatory path as well as an improved safety profile. With an extended duration of therapeutic benefit, this technology will also reduce the treatment burden for patients. www.rippletherapeutics.com

Media Contact (Ripple)

Julie Fotheringham, V.P. Marketing, People & Culture, Ripple Therapeutics

M: 416-951-7988 E: jfotheringham@rippletherapeutics.com

RIPPLE THERAPEUTICS PRESENTS AT EURETINA

Mon, 23 Sep 2024 14:42:29 GMT

Hemal Mehta, MBBS, MD (Cantab.), presented Efficacy and safety of the low dose dexamethasone IBE-814 IVT Implant for diabetic macular edema and retinal vein occlusion: Results of a first-in-human Phase 2 trial, at Euretina Congress in Barcelona, Spain, September 19-22, 2024.

View Presentation

Ripple Therapeutics Announces Collaboration and Option-to-License Agreement with AbbVie to Develop Next-Generation Therapies for Glaucoma Management

Tue, 17 Sep 2024 12:33:41 GMT

- Collaboration to leverage AbbVie's eye care expertise and Ripple’s innovative drug delivery platform to develop next-generation sustained release drug delivery implants for the treatment of glaucoma

TORONTO, CANADA / ACCESSWIRE / September 17, 2024 / − Ripple Therapeutics today announced a collaboration and option-to-license agreement with AbbVie to develop RTC-620, a next generation, fully biodegradable, sustained release drug delivery intracameral implant with repeat dosing capabilities to reduce intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). This collaboration leverages AbbVie's expertise in eye care and Ripple’s innovative drug delivery platform.

Ripple’s patented technology platform is based on a discovery that drugs can be engineered into controlled release pharmaceuticals without the use of polymers or excipients. These proprietary prodrugs undergo surface erosion to give zero order release kinetics and are highly customizable to tailor both drug dose and duration. Because there are no polymers or excipients, once the drug is gone, the implant is gone with no pro-inflammatory degradation products, which supports repeat dosing.

“We’re pleased to partner with AbbVie, a worldwide leader in ophthalmic therapeutics,” said Tom Reeves,President and Chief Executive Officer, Ripple Therapeutics. “By combining our drug delivery platform with AbbVie’s research, clinical, regulatory and commercial capabilities, we hope to deliver a meaningful impact on the lives of people living with glaucoma.”

Millions of people are living with glaucoma, one of the leading causes of vision loss. New treatment options areneeded to help patients challenged with topical drops or who are at risk for vision loss and looking for alternative treatment options.

"At AbbVie, we strive to find innovative solutions to build our portfolio of vision-preserving therapies,” said Michael Robinson, M.D., Vice President and Therapeutic Area Head, Ophthalmology, AbbVie. “We are excited to partner with Ripple to further advance the development of RTC-620."

Under terms of the agreement, Ripple will lead preclinical development of RTC-620. Upon exercise of the option, AbbVie will lead the clinical and commercialization activities. Ripple will receive an upfront payment of $21.8 million from AbbVie and is eligible to receive up to $290 million in aggregate option fees and milestones, as well as tiered royalties on net sales.

About Ripple Therapeutics

Ripple Therapeutics Corporation is a privately held clinical stage company focused on improving ophthalmic therapeutics with controllable sustained delivery implants without the use of polymers or excipients. Our novel therapeutics provide better outcomes for patients, easier management of care for physicians and lower cost for payors. www.rippletherapeutics.com

Piper Sandler acted as the exclusive financial advisor to Ripple.

For further information:

Media: Julie Fotheringham, jfotheringham@rippletherapeutics.com

RIPPLE THERAPEUTICS PRESENTS AT RETINA WORLD CONFERENCE

Tue, 09 Jul 2024 16:07:23 GMT

On May 12, 2024, Baruch Kupperman, MD, PhD, presented Ripple Therapeutics Steroid Drug Delivery Clinical Trial for DME and RVO in the Late Breakers Session, 11:15am.

View Presentation

Ripple Therapeutics Presents at ARVO 2024

Fri, 17 May 2024 14:37:46 GMT

Ocular tolerability and IOP-lowering evaluation of the RTC-620 intracameral implant in normotensive beagle dogs

Ike Iqbal K Ahmed, Kyle Battiston, Shadi Taghavi, Mahta Massoud, Eamon Kelly, Hans Fischer, Dimitra Louka, Matthew Statham, Jonathan Day, Adam Daley, Ian Parrag, Wendy Naimark

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IBE-814 IVT Implants reduce treatment burden in subjects with DME and RVO due to sustained-release of dexamethasone: An analysis of the First-in-Human Phase 2 RIPPLE-1 trial

Kelli Wootton, Gillian Mackey, Madeline Simpson, Joseph Reiz, Wendy Naimark

View Presentation

Efficacy and safety of a low dose dexamethasone implant for diabetic macular edema and retinal vein occlusion: Results of the First-In-Human Phase 2 RIPPLE-1 trial

Hemal Mehta, Kelli Wootton, Madeline Simpson, Gillian Mackey, Wendy Naimark

View Presentation

Chronic ocular tolerability and pharmacodynamics of the RTC-1119 intracameral implant in normotensive beagle dogs

Kyle Battiston, Shadi Taghavi, Hans Fischer, Matthew Statham, Jonathan Day, Emily Baldwin, Adam Daley, Ian Parrag, Wendy Naimark

View Presentation

Ripple Therapeutics Presents at Eyecelerator @ ASCRS 2024

Tue, 16 Apr 2024 13:13:17 GMT

TORONTO, ON, CANADA / APRIL 4, 2024 - Ripple Therapeutics Corporation, a clinical stage company focused on improving ophthalmic therapeutics with controllable sustained delivery implants, was pleased to present at Eyecelerator @ ASCRS 2024 in Boston.

Tom Reeves, our President & CEO, presented at Presenting Company Showcases:

VIEW PRESENTATION

VIEW VIDEO

About Ripple Therapeutics

Ripple Therapeutics Corporation is a privately held clinical stage company focused on improving ophthalmic therapeutics with controllable sustained delivery implants. Ripple’s patented technology platform is based on a discovery that drugs can be engineered into controlled release pharmaceuticals without the use of polymers or excipients. These proprietary prodrugs undergo surface erosion to give zero order release kinetics and are highly engineerable to tailor both drug dose and duration. The advantages of this technology include lower molecular weight and higher drug loading which allows for smaller implants and a lack of degradation products which provides both a clearer regulatory path as well as an improved safety profile. With an extended duration of therapeutic benefit, this technology will also reduce the treatment burden for patients. www.rippletherapeutics.com

Media Contact (Ripple)

Julie Fotheringham, V.P. Marketing, People & Culture, Ripple Therapeutics

M: 416-951-7988 E: jfotheringham@rippletherapeutics.com

Ripple Therapeutics Presents Results of RIPPLE-1 at Ophthalmology Conferences

Thu, 28 Mar 2024 19:51:04 GMT

TORONTO, ON, CANADA / MARCH 28, 2024 - Ripple Therapeutics Corporation, a clinical stage, ophthalmology-focused developer of novel therapeutics, is presenting findings from the RIPPLE-1 clinical trial of the IBE-814 IVT Implant at a number of key Ophthalmology conferences.

Results from RIPPLE-1 showed reduced CST and improved or stable BCVA at Month 6 in all cohorts (high dose and low dose, DME and RVO), a reduction in treatment burden compared to pre-study and safety comparable to other intravitreal steroids. Long-term follow-up is now complete, and analysis of the final data set is in progress.

The IBE-814 IVT Implant is comprised solely of a prodrug, IBE-814, and enables sustained dexamethasone delivery to the retina over a period of at least 6 months. The implant is administered by intravitreal injection using a 30G needle. RIPPLE-1 was a first-in-human phase II, multi-center, single-masked dose-ranging study designed to evaluate the safety, efficacy, and durability of two dosage regimens of the IBE-814 IVT Implant. The study enrolled 60participants with diabetic macular edema (DME) and retinal vein occlusion (RVO). Participants were randomized to receive either the low dose (70 µg) dexamethasone, one implant) or high dose implant (140 µg dexamethasone, two implants) and were followed for up to 18 months post-baseline treatment.

Presented:

American Academy of Ophthalmology (AAO)

Date: November 4, 2023

Presenter: Sumit Sharma, MD, FASRS

Title: Intravitreal Sustained-Release Dexamethasone Implant for DME and RVO: 6-Month Results from the First In-Human Phase 2 RIPPLE-1 Trial

View Presentation

Hawaiian Eye and Retina

Date: January 18, 2024

Presenter: Sumit Sharma, MD, FASRS

Title: Intravitreal Sustained-Release Dexamethasone Implant for DME and RVO: 9-Month Results from the First In-Human Phase 2 RIPPLE-1 Trial

View Presentation

Angiogenesis, Exudation, and Degeneration

Date: February 3, 2024

Presenter: Baruch Kuppermann, MD, PhD

Title: Intravitreal Sustained-Release Dexamethasone Implant for DME and RVO: Interim Results from the First In-Human Phase 2 RIPPLE-1 Trial

View Presentation

Accepted:

The Association for Research in Vision and Ophthalmology (ARVO )

Date: May 9, 2024

Session: 530 Diabetic macular edema, 11:45 am

Presenter: Hemal Mehta, MBBS MD(Cantab.) FRCOphth FRANZCO

Title: Efficacy and safety of a low dose dexamethasone implant for diabetic macular edema and retinal vein occlusion: Results of the first-in-human phase 2 RIPPLE-1 trial

Date: May 7, 2024

Session: 320 Retinitis pigmentosa and macular diseases, 8:30 am

Presenter: Wendy Naimark, PhD, on behalf of Kelli Wootton, MASc

Title: IBE-814 IVT Implants demonstrate a treatment burden reduction in subjects with DME and RVO due to extended-release of dexamethasone: An analysis of the first-in-human phase 2 RIPPLE-1 trial

Retina World Congress

Date: May 12, 2024,

Session: Late Breakers, 11:15 am

Presenter: Baruch Kuppermann, MD, PhD

Title: Ripple Therapeutics Steroid Drug Delivery Clinical Trial for DME and RVO

About Ripple Therapeutics

Ripple Therapeutics Corporation is a clinical stage, privately held company that is focused on ophthalmic therapeutics with controllable, sustainable drug delivery. The core feature of Ripple’s Epidel™ technology is the ability to engineer sustained-release pharmaceuticals with surface erosion release kinetics without the use of polymers or excipients. Ripple’s novel therapeutics provide for better outcomes for patients, easier management of care for physicians and lower costs for payors. Ripple has a full product pipeline in development. www.rippletherapeutics.com

Media Contact

Julie Fotheringham, V.P. Marketing, People & Culture

M: 416-951-7988 E: jfotheringham@rippletherapeutics.com

Hovione and Ripple Enter Strategic Partnership to Expand Epidel Platform into Non-Ophthalmic Space

Mon, 20 Mar 2023 13:00:19 GMT

Lisbon, March 20, 2023, Hovione, the specialist integrated CDMO, leader in spray drying and particle engineering, and Ripple Therapeutics, a leading ophthalmic sustained drug delivery company, have entered a strategic partnership to expand the use of Ripple's Epidel® platform beyond ophthalmic applications.

The core feature of Ripple’s Epidel® technology is the ability to deliver sustained-release pharmaceuticals with surface erosion release kinetics without the use of polymers or excipients. This enables higher drug loading, smaller size implants, defined and predictable biocompatible degradation products with straightforward and scalable manufacturing processes. Surface erosion-based drug release provides a highly effective way to control dose and duration. By incorporating Ripple's Epidel® platform into its toolbox, Hovione can expand its portfolio of novel drug delivery solutions to the pharmaceutical industry.

“The combination of technology synergy, innovative vision and cultural fit makes collaborating with Hovione an exciting next step in the advancement of the Epidel® platform beyond the ophthalmic field,” stated Dr. Wendy Naimark, Ripple co-founder and Chief Technology Officer. “Hovione’s expertise in controlled, sustained drug delivery, along with their experience in chemical synthesis and pharmaceutical manufacturing, makes for a great partnership.”

"We are thrilled to partner with Ripple, who developed a state-of-the-art platform for sustained release," says Dr. Jean-Luc Herbeaux, Hovione's CEO. " Our shared goal is to accelerate and broaden the access to this highly innovative and enabling technology for the benefit of our pharmaceutical customers and their patients worldwide."

By extending the use of the Epidel® platform beyond ocular applications, this partnership will enable the development of a diverse range of new products with optimal sustained release profiles.

About Hovione:

Hovione is an international company with over 60 years of experience in pharmaceutical development and manufacturing operations. As a Contract Development and Manufacturing Organization (CDMO) with a fully integrated offering of services for drug substances, drug product intermediates and drug products. The company has four FDA inspected sites in the USA, Portugal, Ireland and China and development laboratories in Lisbon, Portugal and New Jersey, USA. Hovione provides pharmaceutical customers services for the development and compliant manufacture of innovative drugs, including highly potent compounds, and customized product solutions across the entire drug life cycle. In the inhalation area, Hovione offers a complete range of services, from API, formulation development and devices. Hovione's culture is based on innovation, quality and dependability. Hovione was the first Chemical/ Pharmaceutical Company to become a Certified B Corp, is a member of Rx-360, EFCG and participates actively in industry quality improvement initiatives to lead new global industry standards.

About Ripple Therapeutics:

For more information, please visit www .hovione.com or contact:

Vanessa Romeu | Communications Director | vromeu@hovione.com |Tel: +351 21 982 9000

Or visit www.rippletherapeutics.com or contact:

Julie Fotheringham | V.P. Marketing, People & Culture | 416-951-7988| jfotheringham@rippletherapeutics.com

Ripple Therapeutics is named Best WorkplacesTM for Start Ups

Wed, 25 Jan 2023 14:57:44 GMT

TORONTO, ON, CANADA / JANUARY 24, 2023 - Ripple Therapeutics is proud to announce that our organization has been named on the 2023 Best Workplaces for Start-ups.

Ripple received this honour after a thorough and independent analysis conducted by Great Place to Work®. The list is based on direct feedback from employees of the hundreds of organizations that were surveyed by Great Place to Work®. To be eligible for this list, organizations must be Great Place to Work- Certified™ and have exceptionally high scores from employees on the Trust Index survey.

“At Ripple, we are intentional about investing in people”, commented Tom Reeves, President & CEO. “Our core values emphasize that we care, we collaborate, and we have fun while persevering to find innovative solutions to complex problems. As such, it’s great to receive this independent third-party validation that we are a great place to work.”

About Ripple Therapeutics

Ripple Therapeutics Corporation is a clinical stage, privately held company that is focused on ophthalmic therapeutics with controllable, sustainable drug delivery. The core feature of Ripple’s Epidel™ technology is the ability to engineer sustained-release pharmaceuticals with zero-order release kinetics without the use of polymers or excipients. Ripple has a full product pipeline in development. www.rippletherapeutics.com

About Great Place to Work®

Great Place to Work is the global authority on high-trust, high-performance workplace cultures. Through proprietary assessment tools, advisory services, and certification programs, Great Place to Work recognizes Canada’s Best Workplaces in a series of national lists including those published by The Globe & Mail (Canada) and Fortune magazine (USA). Great Place to Work provides the benchmarks, framework, and expertise needed to create, sustain, and recognize outstanding workplace cultures. Visit us at www.greatplacetowork.ca or find us on Twitter at @GPTW_Canada.

Media Contact

Julie Fotheringham, V.P. Marketing, People & Culture

M: 416-951-7988 E: jfotheringham@rippletherapeutics.com

Ripple Therapeutics Appoints Jonathan Talamo, M.D., to Chair of the Board

Tue, 29 Nov 2022 13:04:32 GMT

TORONTO, ON, CANADA / NOVEMBER 29, 2022 - Ripple Therapeutics Corporation, a clinical stage ophthalmic therapeutics company, today announced Jonathan Talamo, M.D., currently a member of its Board, has been appointed as the new Chair of its Board of Directors.

Dr. Talamo is internationally known as an experienced surgeon and thought leader in ophthalmology. Following 25 years in clinical practice, Dr. Talamo served as the Chief Medical Officer at Ocular Therapeutix, an ophthalmic drug delivery company, where he oversaw development programs in multiple therapeutic areas, including post–cataract surgery inflammation, dry eye, allergy, glaucoma and retinal vascular diseases. Most recently, he served as Chief Medical Officer and Worldwide VP of Clinical and Medical Affairs at Johnson and Johnson Vision. While at J&J, Dr. Talamo helped lead the integration of Abbott Medical Optics as well as the development and launch of numerous innovative products.

“It’s an exciting time at Ripple Therapeutics, with licensing agreements in place and a clinical trial well underway for IBE-814 IVT (treating DME and RVO) and progress towards the clinic with RTC-1119 (treating glaucoma)”, commented Dr. Talamo. “I’m looking forward to working even more closely with the Ripple Board and team to bring important, proprietary extended-release ophthalmic therapeutics to market that address significant unmet needs for patients and clinicians.”

“With his clinical experience as an ophthalmologist and industry experience with both large and small companies, Jon has already brought tremendous insight to our Board”, stated Tom Reeves, President and CEO, Ripple Therapeutics. “Now as Chair, we look forward to his leadership as we work to realize our vision of developing novel therapeutics that provide better outcomes for patients, easier management of care for physicians and lower costs for payors.”

About Ripple Therapeutics

Ripple Therapeutics Corporation is a clinical stage, privately held company that is focused on ophthalmic therapeutics with controllable, sustainable drug delivery. The core feature of Ripple’s Epidel™ technology is the ability to engineer sustained-release pharmaceuticals with zero-order release kinetics without the use of polymers or excipients. Ripple’s novel therapeutics provide for better outcomes for patients, easier management of care for physicians and lower costs for payors. Ripple has a full product pipeline in development. www.rippletherapeutics.com

Media Contact:

Julie Fotheringham, V.P. Marketing, People & Culture

M: 416-951-7988 E: jfotheringham@rippletherapeutics.com

Tom Reeves, President & CEO, presents during OIS Retina on July 13th at the Edison Ballroom NYC.

Fri, 12 Aug 2022 14:03:16 GMT

Ripple Therapeutics is a Great Place to Work

Mon, 20 Jun 2022 13:54:00 GMT

TORONTO, ON, CANADA / JUNE 20, 2022 - Ripple Therapeutics is pleased to announce that we have been certified as a Great Place to Work® after a thorough, independent analysis conducted by Great Place to Work Institute® Canada. This certification is based on direct feedback from employees, provided as part of an extensive and anonymous survey about their workplace experience.

“Having a culture that helps us to attract, develop and retain top talent has always been a critical success factor at Ripple Therapeutics”, commented Tom Reeves, President & CEO. “Our corporate values emphasize that we care, we collaborate and we have fun while persevering to find innovative solutions to complex problems. We want to make sure that Ripple is a great place to work so it’s fantastic to receive this independent third-party validation.”

Nancy Fonseca, Senior Vice President of Great Place to Work® Canada, says that a great workplace is about the level of trust that employees experience in their leaders, the level of pride they have in their jobs, and the extent to which they enjoy their colleagues. "Our data shows that great workplaces benefit from stronger financial performance, reduced turnover, and better customer satisfaction than their peers. What's more, work environments with trust at the foundation are ripe for innovation, agility, resilience and efficiency," Fonseca said.

About Ripple Therapeutics

Ripple Therapeutics Corporation is a clinical stage, privately held company that is focused on ophthalmic therapeutics with controllable, sustainable drug delivery. The core feature of Ripple’s Epidel™ technology is the ability to engineer sustained-release pharmaceuticals with zero-order release kinetics without the use of polymers or excipients. Ripple has a full product pipeline in development. www.rippletherapeutics.com

About Great Place to Work®

Media Contact

Julie Fotheringham, V.P. Marketing, People & Culture

M: 416-951-7988 E: jfotheringham@rippletherapeutics.com

Ian Parrag PhD, Director R&D, presents One Engineer’s Path in Product Development Towards Controlled Drug Delivery at Canadian Biomaterials Society, May 27, 2022.

Fri, 10 Jun 2022 12:29:00 GMT

Ripple Therapeutics work on anti-fibrotic coatings has been published in Biomaterials.

Wed, 01 Jun 2022 14:12:00 GMT

View Full Article

Ike Ahmed, MD FRCSC, presents Preclinical Evaluation of RTC-1119, a Surface Eroding Intracameral Implant Composed Entirely of a Latanoprost acid Prodrug, for Long-term Intraocular Pressure Control,...

Mon, 02 May 2022 15:29:00 GMT

Ripple Therapeutics receives funding support to advance R&D efforts in ophthalmic therapeutics

Wed, 27 Apr 2022 13:49:00 GMT

TORONTO, ON, CANADA / APRIL 27, 2022 - Ripple Therapeutics is pleased to announce that it is receiving advisory services and up to $500,000 in funding from the National Research Council of Canada Industrial Research Assistance Program (NRC IRAP) to support the development of Ripple’s lead product, IBE-814 IVT for the treatment of Diabetic Macular Edema (DME) and Retinal Vein Occlusion (RVO). The project will entail analyzing the data generated from our ongoing clinical trial and the scale up of the product for the next stages on the path to commercialization.

“We are pleased to secure funding and advisory support from NRC IRAP," stated Wendy Naimark, Ripple Therapeutic’s Chief Technology Officer. "Work completed under this program will significantly enhance Ripple’s research and development efforts in ophthalmic therapeutics with controllable, sustainable drug delivery”.

Ripple is currently enrolling patients in RIPPLE-1, a Phase II clinical trial evaluating IBE-814 IVT, a proprietary intravitreal dexamethasone implant targeting DME and RVO patients. The trial seeks to provide a much-needed treatment option: a safer steroid implant with an extended clinical benefit.

About Ripple Therapeutics

Ripple Therapeutics Corporation is a clinical stage, privately held company that is focused on ophthalmic therapeutics with controllable, sustainable drug delivery. The core feature of Ripple’s Epidel™ technology is the ability to engineer sustained-release pharmaceuticals with zero-order release kinetics without the use of polymers or excipients. Ripple has a full product pipeline in development. www.rippletherapeutics.com

Media Contact

Julie Fotheringham, V.P. Marketing, People & Culture

M: 416-951-7988 E: jfotheringham@rippletherapeutics.com

Ripple Therapeutics Announces New Vice President, Operations

Mon, 11 Apr 2022 12:52:00 GMT

TORONTO, ON, CANADA / APRIL 11, 2022 - Ripple Therapeutics Corporation, a clinical stage, ophthalmology-focused developer of novel therapeutics, is pleased to announce the addition of Fraidianie Sévigné, to the leadership team as Vice President, Operations.

Fraidianie brings over 20 years of pharmaceutical industry experience, serving in senior leadership roles encompassing Operations, Quality, Compliance, and Regulatory Strategy. She has contributed to the successful launch of over 130 products, at various stages of development, from clinical evaluations to management of manufacturing scale-up and validation through to commercialization and quality operations for Canadian, U.S. and International markets.

“We are very pleased to welcome Fraidianie to Ripple as VP Operations and a member of our leadership team”, stated Tom Reeves, President and CEO, Ripple Therapeutics. “Her vast experience in both start-up and mature pharmaceutical organizations in Operations, Quality and Regulatory Compliance will be a great complement to our existing team. And her results-oriented leadership style and history of innovation and creativity will fit well with the Ripple culture.”

About Ripple Therapeutics

Ripple Therapeutics Corporation is a clinical stage, privately held company that is focused on ophthalmic therapeutics with controllable, sustainable drug delivery. The core feature of Ripple’s Epidel™ technology is the ability to engineer sustained-release pharmaceuticals with zero-order release kinetics without the use of polymers or excipients. Ripple has a full product pipeline in development. www.rippletherapeutics.com

Media Contact

Julie Fotheringham, V.P. Marketing, People & Culture

M: 416-951-7988 E: jfotheringham@rippletherapeutics.com

Ripple Therapeutic’s Tom Reeves to Present at BIO CEO & Investor Conference

Fri, 11 Feb 2022 20:48:00 GMT

TORONTO, ON, CANADA / FEBRUARY 11, 2022 - Ripple Therapeutics announced today that Tom Reeves, President & CEO, will be presenting at the upcoming 2022 BIO CEO & Investor Conference being held at the Marriott Marquis in NYC on February 14-15 and virtually through the 17th.

Hosted annually by the Biotechnology Innovation Organization (BIO) for over 20 years, the conference is focused on emerging public and private companies, offering a meeting place for institutional investors, industry analysts, and senior biotech executives. The conference draws biotech companies looking to make the connections needed to take their products to the next phase.

Ripple is currently enrolling patients in RIPPLE-1, a Phase II clinical trial evaluating IBE-814 IVT, a proprietary intravitreal dexamethasone implant targeting DME (diabetic macular edema) and RVO (retinal vein occlusion) patients. The trial seeks to provide a much-needed treatment option: a safer steroid implant with an extended clinical benefit.

Ripple is developing a full product pipeline including sustained release therapeutics for glaucoma, post cataract surgery and AMD. Ripple’s glaucoma product (RTC-1119) is an intracameral prostaglandin implant for primary open-angle glaucoma. The target product profile for RTC-1119 is to provide controlled, predictable drug release for 6-12 months and to allow retreatments as required. The product is currently in preclinical development and the company is on target to submit a pre-IND in the second quarter of 2022.

About Ripple Therapeutics

Ripple Therapeutics Corporation is a clinical stage, privately held company that is focused on ophthalmic therapeutics with controllable, sustainable drug delivery. The core feature of Ripple’s Epidel™ technology is the ability to engineer sustained-release pharmaceuticals with zero-order release kinetics without the use of polymers or excipients. Ripple has a full product pipeline in development. www.rippletherapeutics.com

About BIO
BIO is the world's largest advocacy organization representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the BIO International Convention , the world’s largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world. Subscribe to Good Day BIO .

Media Contact

Julie Fotheringham, V.P. Marketing, People & Culture

M: 416-951-7988 E: jfotheringham@rippletherapeutics.com

Ripple’s President & CEO, Tom Reeves, presents at OIS Drug Deliver Forum, Dec 2, 2021

Mon, 06 Dec 2021 16:53:00 GMT

Kyle Battiston, PhD, Sr Engineer Mgr & Wendy Naimark, PhD, CTO, will be presenting at 2021 CRS Virtual Annual Meeting

Wed, 14 Jul 2021 18:28:00 GMT

2021 CRS Virtual Annual Meeting

Ripple’s President & CEO, Tom Reeves, presents at TSX Life Sciences Investor Day.

Mon, 05 Jul 2021 14:08:00 GMT

Ripple Therapeutics Research on Polymer-Free Drug Delivery Published in Nature Communications

Tue, 01 Jun 2021 12:07:00 GMT

TORONTO, ON, CANADA / ACCESSWIRE / JUNE 1, 2021 - Ripple Therapeutics Corporation (“Ripple”), a clinical stage, ophthalmology-focused developer of novel pharmaceuticals, announced today that the article Polymer-Free Corticosteroid Dimer Implants for Controlled and Sustained Drug Delivery was recently published in Nature Communications.

The article describes Ripple’s Epidel™ technology platform which is founded on a discovery that drugs can be engineered into drug delivery implants without the use of polymers or excipients. The proprietary prodrugs are new chemical entities (NCEs) that have unique properties that allow them to be processed into standalone drug delivery implants (e.g. implantable cylinders, micro/nanoparticles, etc.) or as coatings for medical devices without a polymeric carrier. Ripple Therapeutics’ implants and coatings are made up entirely from the prodrug so when the drug is gone the implant is gone. The implants and coatings undergo surface erosion achieving tightly controlled and reproducible release kinetics. Drug release profiles are highly engineerable (e.g. different forms, shapes, and sizes) to tailor drug dose and duration for the specific indication of interest. The flexibility in molecular design results in drug doses that are within the therapeutic window for a specified duration, delivering the right amount of drug for the right amount of time. This has the potential to improve patient safety and clinical outcomes.

“Surface erosion-based drug release enables the most controllable way to precisely design pharmacokinetics and pharmacodynamics for a target indication,” commented Dr. Wendy Naimark, Chief Technology Officer, Ripple Therapeutics. “We purposely design for simplicity to meet both safety and manufacturing goals. The less material the better from a physiological perspective and manufacturing simplicity is important for ensuring process control and ultimately a lower cost of goods.”

Ripple recently announced that the first patients have been enrolled in RIPPLE-1, a Phase II clinical trial evaluating IBE-814 IVT, a proprietary intravitreal dexamethasone implant targeting DME (diabetic macular edema) and RVO (retinal vein occlusion) patients. The trial seeks to provide a much-needed treatment option: a safer steroid implant with an extended clinical benefit.

To read the article visit: https://www.nature.com/articles/s41467-021-23232-7

About Ripple Therapeutics

Ripple Therapeutics Corporation is a clinical stage, privately held company that is focused on ophthalmic therapeutics with controllable, sustainable drug delivery. The core feature of Ripple’s Epidel™ technology is the ability to engineer sustained-release pharmaceuticals with zero-order release kinetics without the use of polymers or excipients. Ripple has a full product pipeline in development. www.rippletherapeutics.com

Media Contact

Julie Fotheringham, V.P. Marketing, People & Culture

M: 416-951-7988 E: jfotheringham@rippletherapeutics.com

New method can improve drug delivery in implants

Thu, 27 May 2021 20:08:00 GMT

Ripple Therapeutics Appoints Jonathan Talamo, M.D., to Board of Directors

Mon, 03 May 2021 16:21:00 GMT

TORONTO, ON, CANADA / ACCESSWIRE / MAY 4, 2021 - Ripple Therapeutics Corporation (“Ripple”) a clinical stage, ophthalmology-focused developer of novel pharmaceuticals, is pleased to announce the appointment of Jonathan Talamo, M.D., to the Board of Directors. Dr. Talamo is internationally known as an ophthalmologist, innovator and consultant to industry with more than 25 years of experience in healthcare.

Dr. Talamo is the former Chief Medical Officer and Worldwide VP of Clinical and Medical Affairs at Johnson and Johnson Vision. Prior to that, he served as the Chief Medical Officer at Ocular Therapeutix, an ophthalmic drug delivery company, where he oversaw clinical development programs in multiple therapeutic areas, including post–cataract surgery inflammation, dry eye, allergy, glaucoma and retinal vascular diseases.

“As a long-time practicing Ophthalmologist who has also worked in industry to develop extended-release ophthalmic medications, I know there are huge unmet needs for patients across multiple disease states”, commented Dr. Talamo. “I’m really excited to work with the Ripple team to bring first-in-class proprietary extended-release ophthalmic therapeutics to market.”

“We are extremely pleased to have Dr. Talamo join our Board of Directors”, stated Tom Reeves, President and CEO, Ripple Therapeutics. “He brings a unique combination of clinical expertise as a practicing ophthalmologist and industry experience with both large and small companies. He will be a great asset for Ripple as we look to realize on our vision of providing safe and effective treatment options for patients with sight-threatening conditions.”

About Ripple Therapeutics:

Ripple Therapeutics Corporation is a clinical stage privately held company that is focused on improving ophthalmic therapeutics with controllable, sustainable drug delivery. The core feature of Ripple’s Epidel technology is the ability to engineer drugs into materials with zero-order release kinetics without the use of polymers or excipients. Ripple has a full product pipeline in development. www.rippletherapeutics.com

Media Contact:

Julie Fotheringham, V.P. Marketing, People & Culture

M: 416-951-7988 E: jfotheringham@rippletherapeutics.com

Ripple Therapeutics Announces First Patient Treated in Phase II Trial Evaluating IBE-814 IVT in DME and RVO

Mon, 19 Apr 2021 18:12:00 GMT

TORONTO, ON, CANADA / ACCESSWIRE / APRIL 20, 2021 - Ripple Therapeutics Corporation (“Ripple”), a clinical stage, ophthalmology-focused developer of novel pharmaceuticals, announced today that the first patient has been treated in RIPPLE-1, a Phase II trial evaluating IBE-814 IVT, a proprietary intravitreal dexamethasone implant targeting inflammatory retinal diseases.

“Our research suggests that ophthalmologists would welcome a safer steroid implant with an extended clinical benefit, as a treatment option for DME and RVO, and we believe that IBE-814 IVT has the potential to fulfill that need,” commented Tom Reeves, President & CEO of Ripple Therapeutics. “The first treated patient marks a significant step forward in our goal of providing safe and effective treatment options for patients with sight-threatening conditions.”

RIPPLE-1 is a phase II, multi-center, single-masked dose-ranging study designed to evaluate the safety and efficacy of two dosage regimens of IBE-814 IVT in patients with diabetic macular edema (DME) or macular edema due to retinal vein occlusion (RVO).

The study will enroll up to 50 eyes of 50 patients with DME or RVO at 15 ophthalmology centers in Australia and New Zealand that specialize in the diagnosis and treatment of retinal diseases. The key study endpoints are safety, macular edema and visual acuity. Retreatment will be allowed upon the return of recurrent symptoms. All patients will be followed for a planned evaluation period of 18 months.

“We are pleased to enroll and treat the very first patient in the RIPPLE-1 trial,” stated Dr. Sanj Wickremasinghe, Principal Investigator at the Centre for Eye Research of Australia. "With the lower but sustained release dose of dexamethasone, I am hopeful that IBE-814 IVT will ultimately provide a much-needed treatment option."

To learn more about the RIPPLE-1 clinical trial, visit: https://clinicaltrials.gov/ct2/show/NCT04576689

About IBE-814 IVT

IBE 814 IVT, is a novel intravitreal implant designed to deliver a low, sustained dose of dexamethasone to the retina for approximately six months, without the use of polymeric carriers or excipients. The implant contains a substantially lower total dose than is used in currently marketed dexamethasone-releasing intravitreal therapies, and is intended to reduce the occurrence of dose-related adverse events that are often associated with conventional intravitreal corticosteroids. The absence of polymers in the formulation results in a much smaller implant, enabling delivery through a smaller and less traumatic 30-gauge needle.

About Diabetic Macular Edema

Persistently high blood sugar levels can damage blood vessels of the retina, leading to fluid leakage within the macula ¹ – the area of the retina that is associated with clear, central vision. The accumulation of fluid results in swelling of the macula (known as macular edema) which can lead to loss of visual acuity. ² DME is a leading cause of blindness in people with diabetes and affects an estimated 21 million people worldwide. ^3,4

About Macular Edema due to Retinal Vein Occlusion

Globally, an estimated 28 million people live with a retinal vein occlusion. ⁵ RVO occurs when a small blood clot blocks a retinal vein preventing blood return from the retina. Bleeding and leakage of fluid from the blocked vessels into the macula cause swelling (macular edema) resulting in blurring or loss of vision. RVO is the second most common cause of vision loss due retinal vascular disease. ⁶

About Ripple Therapeutics

Ripple Therapeutics Corporation is a clinical stage, privately held company that is focused on ophthalmic therapeutics with controllable, sustainable drug delivery. The core feature of Ripple’s Epidel™ technology is the ability to engineer sustained-release pharmaceuticals with zero-order release kinetics without the use of polymers or excipients. Ripple has a full product pipeline in development. www.rippletherapeutics.com

Media Contact

Julie Fotheringham, V.P. Marketing, People & Culture

M: 416-951-7988 E: jfotheringham@rippletherapeutics.com

Ripple’s CEO, Tom Reeves, presents at 2021 BIOTECanada Investor Summit

Wed, 10 Mar 2021 18:42:00 GMT

Sheardown Lab and Ripple Therapeutics receive NSERC grant to improve treatment for millions with eye disease

Wed, 10 Feb 2021 21:46:00 GMT

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Ripple presents at 2021 OBIO Investment Summit, Canada’s Premier Health Science Investment Event

Wed, 10 Feb 2021 21:07:00 GMT

Click to View PDF

Tom Reeves, President & CEO of Ripple Therapeutics presents at Biotech Showcase

Wed, 03 Feb 2021 20:46:00 GMT

Ripple Therapeutics lead candidate attracts strategic investment and licensing partner

Tue, 15 Dec 2020 14:28:00 GMT

Closely-held Ripple Therapeutics inked a transformative strategic investment and licensing deal for its lead product candidate, IBE-814 IVT, an intravitreal implant being developed for the treatment of diabetic macular edema (DME) and retinal vein occlusion (RVO).

Ripple’s new partner, France’s Théa Open Innovation (TOI), is a wholly-owned subsidiary of Laboratoires Théa, the leading independent ophthalmology company in Europe with a presence in 75 countries.

“Laboratoires Théa is an ideal partner for Ripple given their extensive experience in ophthalmology and successful track record in bringing innovative products to market,” Tom Reeves, president and CEO, says in an interview with BioTuesdays.

TOI acquired an exclusive license to Ripple’s IBE-814 IVT in North America and Europe for an upfront payment; clinical and regulatory milestone payments; and double-digit royalties on product sales. In addition, Laboratoires Théa agreed to pay for IBE-814 IVT’s Phase 3 clinical development.

“We view this as a win because we would otherwise have to conduct a $50-million to $75-million Series B financing in two-to-three years to fund the Phase 3 trials,” Mr. Reeves points out.

Laboratoires Théa’s president, Jean-Frédéric Chibret, says that being an independent, family-owned and -run company with a 100% dedication to ophthalmology “enables us to have a faster decision-making process and reinvest profits into our two main growth drivers, innovation and geographic expansion, while working toward a long-term vision.”

Two years ago, Laboratories Théa established TOI to support partnerships with companies, universities, biotechs or ophthalmologists developing innovative eye care products.

“We offer innovative products across a wide range of ophthalmology indications, and until recently, did not have a presence in retinal disease,” Mr. Chibret says. “That is why this partnership with Ripple is an important, and strategic one for Laboratories Théa – it aligns with our strategy to enter into new ophthalmology markets and gain a presence in North America.”

In connection with the license agreement, Laboratories Théa was the lead investor in Ripple’s $14.8-million Series A financing that closed on Dec. 10. “These funds will support IBE-814 IVT’s development through Phase 2 clinical trials, and potentially to IND approval for a Phase 3 trial,” Mr. Reeves adds.

IBE-814 IVT is a dexamethasone prodrug implant based on Ripple’s Epidel technology. “It’s a fundamental discovery on how to deliver drugs in a completely different way,” says Wendy Naimark, Ph.D., Ripple’s VP research and development. She explains that the conventional approach to controlled drug delivery is to mix a drug with a polymer to create implants or coatings.

“We discovered we could take the polymer out of the equation by covalently linking two dexamethasone molecules with triethylene glycol to create what I like to call a ‘dexamethasone dumbbell,’” she says. Unexpectedly, the small 1,000 molecular weight-molecule formed a solid 3D structure that dissolved into its original components, resulting in a mechanism for precise and sustained controlled drug delivery.

Ripple has received four patent allowances related to composition of matter and steroid drug delivery. Two of these allowances were fast tracked and granted within a year. “We’re building a very strong portfolio to patent the technology as broadly as possible,” says Dr. Naimark.

For the past twelve months, the company has been working on IBE-814 IVT’s chemistry, manufacturing and controls program to advance the drug candidate to Phase 2 trials. “The process of making and extruding the material; designing our own injector and finally releasing the clinical batch was very challenging,” Dr. Naimark recalls. Ripple is conducting a Phase 2 trial of IBE-814 IVT in Australia and New Zealand, with the first patient expected to be treated in early 2021.

In addition to the 10 approved clinical trial sites in Australia, Ripple has two clinical sites approved in New Zealand. “We are fortunate for having chosen to start in Australia, as COVID-19 has had a lower impact in that country compared to others,” Mr. Reeves points out.

The company has started site initiation activities as well as screening DME and RVO patients. The Phase 2 trial will enroll 50 patients, with seven patients starting on low-dose IBE-814 IVT before placing additional patients on a higher dose. The trial’s key endpoints are best-corrected visual acuity and central subfield thickness of the macula at six months. Patients will be followed for 18 months.

“This is exploratory work that will inform the design of the Phase 3 trial,” Dr. Naimark explains. “We plan to enroll the last patient in the fall of 2021 and expect six-month primary endpoint data in the first quarter of 2022.

Mr. Reeves points out that Ripple has focused on developing the Epidel platform for ophthalmic indications. In addition to IBE-814 IVT for DME and RVO, the company is developing candidates for glaucoma, wet age-related macular degeneration (AMD), post-cataract surgery, and dry AMD. “We have been evaluating Epidel’s feasibility with other drug classes and found the platform can be applied to a variety of molecules.”

Earlier this year, Ripple demonstrated that it could chemically engineer prostaglandins, which are oils, to create solids that can be extruded into implants. These prostaglandin-based implants exhibited similar sustained drug release as Ripple’s steroid-based implant.

The finding led to the selection of the company’s second drug candidate, RTC-1119, a prostaglandin-based intracameral implant for the treatment of glaucoma. Mr. Reeves says that Ripple’s recently completed financing also will fund planned acute and chronic preclinical work on RTC-1119, which “could represent a bigger opportunity than our lead program because there are few sustained-release therapeutic alternatives in the glaucoma space.”

“Putting implants into the intracameral space is a challenge. Because our technology eliminates the need for a polymer, we can provide controlled drug release with a smaller implant, and eliminate implant swelling, which we believe will be associated with fewer safety concerns, compared with other implants being developed for glaucoma,” she contends.

Mr. Reeves points out that the Epidel technology has many potential applications beyond ophthalmology, and that Ripple is currently in talks with several companies that are developing continuous glucose monitors. “By coating our dexamethasone prodrugs onto an implantable sensor, you can reduce fibrosis associated with the body’s foreign body response and therefore extend the life of the sensor from five-to-seven days to two-to-three weeks.”

Other potential applications of the technology include the controlled delivery of an opioid antagonist for the treatment of opioid use disorder; and extended-release medication for the treatment of pain in post-surgical and osteoarthritis patients.

Mr. Reeves adds that Ripple plans to raise an additional $7-million in early 2021 to continue to develop its Epidel technology platform and accelerate its product pipeline initiatives. “We’ll also evaluate opportunities to license or acquire unique ophthalmology drug candidates from early-stage companies where the Epidel platform could provide an effective delivery vehicle.”

To connect with Ripple or any of the other companies featured on BioTuesdays, send us an email at editor@biotuesdays.com .

Ripple Therapeutics Secures Licensing Agreement and Series A Financing led by Théa Open Innovation

Mon, 14 Dec 2020 16:43:00 GMT

TORONTO, ON, CANADA / ACCESSWIRE / DECEMBER 15, 2020 - Ripple Therapeutics Corporation (“Ripple” or “the Company”), a clinical stage, ophthalmology-focused developer of novel therapeutics, announced today the signing of an exclusive Licensing Agreement for the rights to their lead product, IBE-814, for North America and Europe with Théa Open Innovation (“TOI”) a wholly owned subsidiary of Laboratoires Théa, the leading independent ophthalmology pharmaceutical company in Europe. In addition to the Licensing Agreement, Ripple announced that TOI is leading their Series A Financing.

Ripple’s Epidel™ technology platform is founded on a discovery that drugs can be engineered into controlled release pharmaceuticals without the use of polymers or excipients. The proprietary prodrugs have unique properties that allow them to be processed into standalone drug delivery implants (e.g. intravitreal implants and micro/nanoparticles) or as coatings on medical devices. The implants and coatings undergo surface erosion to give zero order drug release kinetics and are highly engineerable (e.g. different forms, shapes, and sizes) to tailor drug dose and duration for the specific indication of interest.

Ripple’s lead program – IBE-814 IVT – is an intravitreal dexamethasone prodrug implant targeting diabetic macular edema (DME) and retinal vein occlusion (RVO). RIPPLE-1, a Phase II trial evaluating IBE-814 IVT, has been initiated in Australia and New Zealand with the first patient treatment expected in early 2021.

The licensing deal with TOI includes a significant upfront payment, sizeable clinical and regulatory milestones and double-digit royalties. As part of the Licensing Agreement, TOI will also manage and finance the Phase III pivotal trials for IBE-814 IVT.

The Series A Financing is being led by TOI with participation by existing investor Business Development Bank of Canada (BDC) and management with an initial tranche of $14.8M which closed on December 10 ^th . Ripple is looking to raise an additional $7.2M in a second tranche which will close in March 2021. These additional funds will support investment in pipeline opportunities and continued technology platform development.

“Despite COVID-19, we have made significant progress with both IBE-814 IVT and our ophthalmology product pipeline since the spin-out of Ripple back in January. The Licensing Agreement with TOI underscores the potential commercial value of a sustained release steroid for DME and RVO and validates the strength of our Epidel™ technology platform” stated Tom Reeves, President and CEO of Ripple Therapeutics. “Théa is an ideal partner for IBE-814 IVT given their extensive experience in ophthalmology and successful track record in bringing innovative products to market. We’re also honored that TOI is leading our Series A financing and appreciate the ongoing support of BDC in this financing round as well.”

“Théa Open Innovation was founded precisely for this type of collaboration and investment”, stated Jean-Frédéric Chibret, President of Laboratoires Théa. “Our mission is to identify, evaluate, and develop innovative ophthalmic and eye care solutions in partnership with companies like Ripple and to provide the funding required to conduct clinical trials. We have been very impressed by the Ripple team and the progress they have made with IBE-814 IVT. We look forward to working together to bring this sustained delivery technology to patients.”

About Ripple Therapeutics:

Ripple Therapeutics Corporation is a clinical stage privately held company that is focused on improving ophthalmic therapeutics with controllable, sustainable drug delivery. The core feature of Ripple’s Epidel™ technology is the ability to engineer drugs into materials with zero-order release kinetics without the use of polymers or excipients. Ripple has a full product pipeline with the first program entering the clinic in early 2021. www.rippletherapeutics.com

About Théa:

Théa is the leading European pharmaceutical group (outside the retina sector). Based in Clermont-Ferrand, France, it runs more than thirty affiliates and offices in Europe, North Africa, North and South America, and the Middle East. Entirely dedicated to ophthalmology, this independent family company has a network of some 1500 collaborators, and its products are available in 74 countries worldwide. https://www.laboratoires-thea.com/en

Théa Media Contact:

Lorraine Kaltenbach, Director of Communications

M: +33 674740252 E: lorraine.kaltenbach@theapharma.com

Ripple Media Contact:

Julie Fotheringham, V.P. Marketing, People & Culture

M: 416-951-7988 E: jfotheringham@rippletherapeutics.com

Ripple Presents at ARVO 2020

Tue, 20 Oct 2020 18:32:00 GMT

Ripple Series A Financing – watch this.

Wed, 12 Feb 2020 13:57:00 GMT

Ripple Therapeutics pursues financing for Phase 2 intravitreal implant trial and Epidel platform expansion

Wed, 12 Feb 2020 13:36:00 GMT

Closely-held Ripple Therapeutics , a recent spinout from Interface Biologics, is pursuing a $25-million series A financing to complete a Phase 2 trial of IBE-814 IVT, a dexamethasone prodrug intravitreal implant, and continue developing its Epidel technology platform.

“While this technology has broad applications across different drug classes and therapeutic areas, we chose to focus on ophthalmic indications because of a large and growing market, significant unmet medical needs and a robust M&A marketplace,” Tom Reeves, president and CEO, says in an interview with BioTuesdays.

Ripple is initially targeting the diabetic macular edema (DME) and retinal vein occlusion (RVO) markets. DME and RVO impact some one million individuals in the U.S., and a large portion of these patients either exhibit suboptimal responses or are refractive to currently approved therapies.

Mr. Reeves says that about a third of patients don’t respond to anti-VEGF injections, the first-line therapy for DME and RVO, representing a second-line market opportunity of approximately $1-billion.

Wendy Naimark, VP research and development, says that the Epidel technology is based on a discovery that drugs can be engineered into controlled-release materials without the use of polymers or excipients.

“We develop proprietary prodrugs with unique properties that allow them to be processed into standalone sustained-release drug delivery implants or coatings for medical devices,” she explains.

Ripple’s implants and coatings consist entirely of prodrug, and do not contain polymeric carriers to control drug release properties. Instead, the implants and coatings undergo surface erosion to give zero-order drug release profiles, or the sustained release of a constant amount of prodrug.

Using the Epidel technology, implants can be engineered to deliver a specific drug dose for a set duration, based on the indication, which Dr. Naimark says has the potential to improve patient safety and clinical outcomes.

“We expect two fast track patents to be granted in April of this year, which we consider a testament to the novelty of this invention,” she contends.

Ripple’s lead candidate, IBE 814 IVT, is an intravitreal implant designed to deliver a low, sustained dose of dexamethasone for six months. The implant contains 10% of the dose used in dexamethasone-releasing products currently on the market, and the absence of a polymeric matrix results in a much smaller implant, enabling delivery through a 30-gauge needle, compared with a 22-to-25 gauge needle.

“In preclinical studies, we’ve demonstrated that IBE-814 IVT provides zero-order dexamethasone delivery out to six months,” Dr. Naimark points out. “This reflects the inhibition of VEGF-induced vascular leakage for up to six months that we also observed, which compares with less than 10 weeks for the commercially available dexamethasone-releasing product.”

The company received FDA agreement for a 505(b)(2) regulatory pathway in October 2018, enabling an expedited approval path. Ripple recently initiated GMP implant manufacturing in preparation to launch a Phase 2 study designed to evaluate and compare the safety and early efficacy of two IBE-814 IVT dosage regimens in patients with DME and RVO.

Dr. Naimark says that a three-month interim analysis will provide early indicators of efficacy, measured by best corrected vision acuity (BCVA) and a decrease in macular edema, as well identify any adverse events, particularly increased intraocular pressure. The trial’s primary endpoint is BCVA at six months, though patients will be followed for 18 months.

“In addition to a longer duration of effect, what we hope to see with IBE-814 IVT is a decrease in drug-related adverse events, such as increased intraocular pressure and cataracts,” says Dr. Naimark, suggesting IBE-814 IVT’s lower drug load may contribute to a superior clinical profile.

Ripple has earmarked $18-million of its planned $25-million raise to complete the Phase 2 trial and IND application for IBE-814 IVT, with the remainder allocated to developing its pipeline of drugs based on the Epidel technology.

“In the world of drug delivery, surface erosion-based drug release is the ‘holy grail’ in that it enables predictable and controlled drug release,” Dr. Naimark says. “You could say that we are molecular designers – we rationally design drug release profiles based on the fact that the surface area of an implant is directly proportional to the rate at which the prodrug is released.”

Ripple has demonstrated the technology’s versatility with a variety of active pharmaceutical ingredients. By changing the active drug, prodrug linker and/or implant dimensions, drug release kinetics can be altered to achieve drug- and environment-specific release profiles.

Mr. Reeves contends that Ripple is “more than just a steroid play,” explaining that the Epidel technology can be used to achieve specific delivery profiles for various, and multiple, drugs.

Ripple is also developing IBE-119, a prostaglandin-releasing intracameral implant for the treatment of primary open-angle glaucoma. Ripple believes the Epidel technology is particularly well-suited for this indication, given the constrained intracameral space and physician feedback, indicating a target delivery duration of six months.

Beyond its ophthalmology pipeline, which also includes discovery-stage candidates for post-cataract inflammation and wet age-related macular degeneration, Ripple has identified additional therapeutic areas that can benefit from the Epidel technology.

For example, the life of implantable sensors, such as those used by patients with diabetes for continuous glucose monitoring, can be extended when coated with the Epidel steroid prodrugs. The company is also investigating opportunities in osteoarthritis pain management using steroid prodrug microspheres.

Mr. Reeves notes that major value inflection points can be expected in the near-term. “With the start of our Phase 2 clinical trial for our lead program in the second half of 2020, followed by interim and primary endpoint data at three and six months, respectively, we see multiple short-term value inflection points that, when combined with a strong product pipeline and robust patented technology platform, makes the Ripple story very compelling.”

Editor’s note: This article does not constitute an offer to sell or the solicitation of an offer to buy any securities of Ripple Therapeutics and shall not constitute an offer, solicitation or sale of any security in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Interface Biologics Announces Spinout, Ripple Therapeutics

Tue, 14 Jan 2020 13:30:00 GMT

,p.TORONTO, Canada, January 14, 2020 – Following the sale of its surface modification business to Evonik (EVR:ETK), Interface Biologics Inc. (“IBI”), is pleased to announce the launch of Ripple Therapeutics Corporation (“Ripple”), a privately held, clinical stage developer of novel drugs.

The Ripple Epidel ^® technology is founded on a discovery that drugs can be engineered into controlled release Pharmaceuticals and Medical Device Coatings without the use of polymers or excipients. The proprietary prodrugs are new chemical entities (NCEs) that have unique properties that allow them to be processed into standalone drug delivery implants (e.g. intravitreal implants and micro/nanoparticles) or as coatings on medical devices. The implants and coatings undergo surface erosion to give zero order drug release profiles and are highly engineerable (e.g. different forms, shapes, and sizes) to tailor drug dose and duration for the specific indication of interest. The flexibility in molecular design results in drug doses that are within the therapeutic window, delivering the right amount of drug for the right amount of time. This has the potential to improve patient safety and clinical outcomes.

Ripple’s lead product, IBE-814 IVT, is a fully degradable intravitreal dexamethasone prodrug implant that targets diabetic macular edema and retinal vein occlusion. IBE-814 is designed to deliver a low, consistent, efficacious dose for six to nine months which is significantly longer than the leading commercial product. With ~1/10th the drug loading, there is also the potential of reducing the steroid-related adverse events that affect the current commercial products. The FDA has confirmed an abbreviated regulatory path via 505(b)(2) and the company is planning to initiate its Phase II clinical trial in Australia in the second half of 2020.

“Following the successful sale of our surface modification business to Evonik, we felt that the best way to capitalize on our Epidel technology was to create a new company – Ripple Therapeutics – in order to facilitate incremental investment,” stated Tom Reeves, President & CEO of Interface Biologics and Ripple Therapeutics. “IBI will continue to focus on its licensing agreement with Fresenius Medical Care and to develop its drug coated balloon program using the Kinesyx platform. The majority of former IBI management and employees will transition to Ripple Therapeutics. Ripple’s initial focus is in ophthalmology, but this technology platform has wide ranging capabilities for sustained local drug delivery across a variety of drug classes and therapeutic areas. We are actively pursuing a $25M Series A financing which will allow us to take our lead product, IBE-814 IVT, through a Phase II clinical trial as well as to continue to develop the technology platform and other product applications.”

About Interface Biologics:

Interface Biologics (IBI) is an early commercial stage privately held company that develops innovative materials for Medtech applications. IBI surface modification additives are used in FDA- approved medical devices and are clinically proven to reduce infection and thrombus-related complications. www.interfacebiologics.com

About Ripple Therapeutics:

Ripple Therapeutics Corporation is an early clinical stage privately held company that develops novel drugs. Ripple’s EpidelÒ technology is founded on a discovery that drugs can be engineered into controlled release Pharmaceuticals and Medical Device Coatings without the use of polymers or excipients. The proprietary prodrugs are new chemical entities (NCEs) that have unique properties that allow them to be processed into standalone drug delivery implants or as coatings on medical devices. www.rippletherapeutics.com

Media Contact:

Julie Fotheringham, Partner, Hageman Communications

M: 416-951-7988 E: Julie.fotheringham@hageman.ca

Fresenius Medical Care Receives FDA Breakthrough Device Designation for New Dialysis System to Prevent Blood Clotting Without the Use of Blood Thinners

Fri, 13 Dec 2019 15:44:00 GMT

WALTHAM, Mass. , Oct. 24, 2019 /PRNewswire/ -- Fresenius Medical Care North America (FMCNA), the nation's leading provider of kidney care products and services, announced today that the U.S. Food and Drug Administration (FDA) has granted breakthrough device designation to a new hemodialysis system, currently in development, that aims to prevent blood clotting without the use of blood thinner medication in most patients.

The antithrombogenic additive, Endexo ^® , is being incorporated into the manufacturing process of dialyzers and bloodlines. Endexo is a polymer made of surface modifying molecules that are designed to inhibit the adsorption of protein and platelets, which in turn can potentially reduce clot risk and increase hemocompatibility. Citrasate ^® dialysate would be used with the new dialyzers and bloodlines as part of this novel system.

"Harnessing our innovational expertise, we continuously strive to make significant advances in our products and provide new solutions for people with chronic kidney disease worldwide," said Dr. Olaf Schermeier, Chief Executive Officer for Global Research and Development at Fresenius Medical Care. "Receiving this designation, we are right on track with a new dialysis system that will directly benefit our patients' well-being."

Many dialysis patients are currently prescribed blood thinners, like heparin, to reduce the risk of clotting as blood travels from their body, through bloodlines, and into the dialyzers that filter out toxins. The new technology aims to reduce the need for these blood thinners, which can have dangerous side effects. Fresenius Medical Care holds an exclusive worldwide license from Interface Biologics to apply the Endexo technology to various hemodialysis components, including dialyzers and blood lines.

"This new dialysis system builds on our commitment to innovate in ways that continuously improve patient safety and health outcomes," said Mark Costanzo , president of FMCNA's Renal Therapies Group. "We are proud to be leading the way in designing the future of life-sustaining dialysis treatments."

"We are hopeful this new system will help eliminate the reliance on heparin during dialysis to improve treatments for most patients," said Dr. Robert Kossmann , chief medical officer for FMCNA. "The work to achieve this breakthrough has been years in the making and we are excited that the FDA has recognized the importance of bringing this technology to market as quickly as possible."

This FDA Breakthrough Device Designation is the second that the company has earned this year. In March, the FDA granted the designation to FMCNA's computer-assisted ultrafiltration (UF) control software currently in development to improve fluid management during hemodialysis and personalize treatments.

The FDA Breakthrough Device Program seeks to provide patients with faster access to technologies that provide more effective treatment or diagnosis of life-threatening or debilitating diseases by speeding up the development and review process. The FDA announced final guidance for the Breakthrough Devices Program on December 19, 2018 . The program was established by the 21st Century Cures Act.

Research supporting the development of this new system will be presented at the American Society of Nephrology's Kidney Week in November.

About Fresenius Medical Care North America

Fresenius Medical Care North America (FMCNA) is the premier healthcare company focused on providing the highest quality care to people with renal and other chronic conditions. Through its industry-leading network of dialysis facilities, outpatient cardiac and vascular labs and urgent care centers, Fresenius Medical Care North America provides coordinated healthcare services at pivotal care points for hundreds of thousands of chronically ill customers throughout the continent. As the world's largest fully integrated renal company, it offers specialty pharmacy and laboratory services, and manufactures and distributes the most comprehensive line of dialysis equipment, disposable products and renal pharmaceuticals. For more information, visit the FMCNA website at https://fmcna.com .

Disclaimer

This release contains forward-looking statements that are subject to various risks and uncertainties. Actual results could differ materially from those described in these forward-looking statements due to certain factors, including changes in business, economic and competitive conditions, regulatory reforms, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. These and other risks and uncertainties are detailed in Fresenius Medical Care AG & Co. KGaA's reports filed with the U.S. Securities and Exchange Commission. Fresenius Medical Care AG & Co. KGaA does not undertake any responsibility to update the forward-looking statements in this release.

Media Contact:

Fresenius Medical Care North America

Brad Puffer Corporate Communications

brad.puffer@fmc-na.com

(781) 699-3331

© 2019 Fresenius Medical Care. All Rights Reserved. Fresenius Medical Care, the triangle logo and Fresenius Renal Technologies are trademarks of Fresenius Medical Care Holdings, Inc. or its affiliated companies. Citrasate is a registered trademark of Advanced Renal Technologies used under license. Endexo is a registered trademark of Interface Biologics, Inc. used under license. All other trademarks are the property of their respective owners

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Interface Biologics Announces Sale of Surface Modification Business to Evonik

Fri, 13 Dec 2019 15:44:00 GMT

TORONTO, Canada, September 3, 2019 – Interface Biologics Inc. (“IBI”), a privately held, commercial stage developer of innovative material science technologies for Medtech and Pharmaceutical applications, is pleased to announce the sale of its surface modification business to Evonik (EVR: ETK), a German based specialty chemical company with revenues in excess of €13 billion in 2018. The Health Care business line of Evonik, a leading supplier of products and services to the pharmaceutical, medical device and nutraceutical industries, will be running the business. The sale does not include IBI’s licensing agreement with Fresenius Medical Care for certain dialysis fields of use.

IBI’s surface modification business is centered around its Endexo® technology, patent protected macromolecules which enhance the biocompatibility of medical devices that come in contact with blood, tissue or other biological fluids. These low molecular weight fluoro-oligomeric additives migrate to the top few nanometers of the devices surface without any changes required in the manufacturing process. In the presence of blood, the modified surfaces are able to suppress procoagulant protein conformation, reduce platelet adhesion and inhibit platelet activation. In the presence of bacteria mediated fluids, the modified surfaces are effective at reducing bacteria adhesion and encrustation. Endexo® modified devices have been clinically proven to reduce infection and thrombus-related complications in FDA-cleared medical devices. The Endexo® platform technology can be applied to a variety of base polymers and manufacturing techniques and become an integral part of the base material without compromising device functionality.

“We are excited to onboard the Endexo® technology in our portfolio.” said Jean-Luc Herbeaux, SVP and General Manager of the Health Care business line of Evonik. “Endexo® expands our ability to serve as a development partner and solution provider to medical device companies worldwide. The team of Interface Biologics has done an exemplary job developing this innovative technology and bringing it to market. We look forward to applying our global business development capabilities and technical prowess to further expand the geographic and application footprint of Endexo®.”

“This is an exciting time for our organization”, stated Tom Reeves, President & CEO of Interface Biologics, Inc. “The sale of our Surface Modification business to Evonik is the culmination of years of hard work in developing the underlying Endexo® technology and building value for our customers by improving the safety and effectiveness of their medical devices. We have been working with Evonik on joint development opportunities over the last few years and I’m confident that the combination of our technology platform and the technical, commercial and financial resources of Evonik will allow us to accelerate the utilization of the Endexo® technology in broader sectors of the medical device market. I’m proud that a major multinational player like Evonik has chosen to build on IBI’s expertise in surface modification by maintaining a presence in Toronto which is a testament to the capabilities of the entire local ecosystem. I’m also excited about the continued progress with our Epidel® and Kinesyx® local drug delivery technology platforms and look forward to communicating specifics on our product development and financial strategies in the next few months.

IBI Poster at AUA 2019: In vitro evaluation of novel surface modifying molecules to prevent bacterial adhesion to urological devices

Fri, 13 Dec 2019 15:44:00 GMT

View PDF

Pharmacokinetics and Pharmacodynamics of a Novel Dexamethasone Intravitreal Implant IBI Abstract Presented at ARVO 2019

Fri, 13 Dec 2019 15:44:00 GMT

Monday April 29 ^th

11:15am - 11:30am

Location: East 2/3

Presentation Number: 1702

Author: Baruch D. Kuppermann ¹ , Ian Parrag ² , Dimitra Louka ² , Hans Fischer ² , Gillian Mackey ² , Ben B. Muirhead ³ , Emily Anne Hicks ³ , Heather Sheardown ³ , Wendy Naimark ²
¹ Gavin Herbert Eye Inst. UCI Dept Ophthal, University of California Irvine, Irvine, California, United States; ² Interface Biologics, Toronto, Ontario, Canada; ³ Biomedical Engineering, McMaster University, Hamilton, Ontario, Canada;

Purpose
Local drug delivery via surface erosion enables highly controlled, sustained release of drug. We have developed a novel approach to drug delivery in the eye that employs an erosion-based mechanism of drug release from a fully degradable, nonpolymeric implant. The lead product in development is an intravitreal implant (IBE-814 IVT) that releases dexamethasone to treat posterior inflammatory conditions. We have evaluated the pharmacokinetics (PK) and pharmacodynamics (PD) of the IBE-814 IVT implants in rabbits to demonstrate sustained dexamethasone release for ~6 months with implants delivered through a 30G needle.

Methods
PK of the IBE-814 IVT implants were tested in New Zealand white rabbits following intravitreal injection of the implants. Terminal time points of 1, 2, 8, 16, 26, and 40 weeks were used and drug was quantified in ocular tissues by LC/MS/MS. A rabbit VEGF-induced vascular leakage model was used to test the PD of IBE-814 IVT implants in inhibiting blood-retinal barrier breakdown. Dutch Belted rabbits underwent bilateral intravitreal injection on Day 0 and vascular leakage was induced by VEGF (1000 ng/eye) at 1, 10, and 26 weeks post-implantation. Inhibition of VEGF-induced vascular leakage was evaluated by fundus microscopy and fluorescein angiography. Commercially available dexamethasone implants were used as a control in both studies.

Results
The IBE-814 IVT implants released a low and consistent dose of dexamethasone (~6-15 ng/ml) in the vitreous humour of the rabbit eye out to at least 8 weeks, with later time points ongoing. In contrast, commercial dexamethasone implants had an initial burst release with no drug detected in the vitreous humor at week 8. The low, consistent dose of dexamethasone released from the IBE-814 IVT implants inhibited VEGF-induced vascular leakage at weeks 1 and 10 in the VEGF model as observed by fluorescein angiography. Commercial dexamethasone implants inhibited VEGF-induced vascular leakage at week 1 but not at week 10.

Conclusions
The IBE-814 IVT implant is a novel biodegradable surface-eroding implant delivered with a 30G needle that releases a low, consistent, and efficacious dose of dexamethasone out to at least 10 weeks in rabbits. Ongoing studies will assess drug release out to ~6 months.

Layman Abstract: Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details.
The IBE-814 IVT implant is a fully degradable, non-polymeric intravitreal implant designed to deliver a consistent, low dose of dexamethasone for posterior ocular inflammatory diseases. The target implant will be injected with a minimally invasive 30 gauge needle and will be able to deliver a low dose of dexamethasone for approximately 6 months. The development of an effective low-dose, 6-month steroid-releasing invtravitreal implant has the potential to decrease repeat treatment frequency.

Interface Biologics presents at OIS@AAO

Tue, 01 Oct 2019 19:29:00 GMT

Click to View

Wendy Naimark, PhD, V.P. R&D speaks on Retinal Drug Delivery Solutions at OIS@ASRS2019

Thu, 01 Aug 2019 19:24:00 GMT

News

RIPPLE-ABBVIE OPHTHALMIC DRUG DELIVERY PANEL

Ripple Therapeutics Enters Collaboration with Bausch + Lomb

Overview of the Epidel® Prodrug Engineered Sustained Drug Delivery Platform Wendy Naimark, CTO & Co-Founder

OIS XV

Why a Homegrown Biotech Sector Matters for Canada

A breakthrough for patients with eye disease

The “missing middle”

Creating a sustainable Canadian biotech ecosystem

Ripple is featured in LSO’s Success Stories

Ripple Therapeutics Announces Evaluation and Licensing Agreements with Glaukos

RIPPLE THERAPEUTICS PRESENTS AT EURETINA

Ripple Therapeutics Announces Collaboration and Option-to-License Agreement with AbbVie to Develop Next-Generation Therapies for Glaucoma Management

RIPPLE THERAPEUTICS PRESENTS AT RETINA WORLD CONFERENCE

Ripple Therapeutics Presents at ARVO 2024

Ocular tolerability and IOP-lowering evaluation of the RTC-620 intracameral implant in normotensive beagle dogs

﻿ IBE-814 IVT Implants reduce treatment burden in subjects with DME and RVO due to sustained-release of dexamethasone: An analysis of the First-in-Human Phase 2 RIPPLE-1 trial

﻿ Efficacy and safety of a low dose dexamethasone implant for diabetic macular edema and retinal vein occlusion: Results of the First-In-Human Phase 2 RIPPLE-1 trial

﻿ Chronic ocular tolerability and pharmacodynamics of the RTC-1119 intracameral implant in normotensive beagle dogs

Ripple Therapeutics Presents at Eyecelerator @ ASCRS 2024

Ripple Therapeutics Presents Results of RIPPLE-1 at Ophthalmology Conferences

Hovione and Ripple Enter Strategic Partnership to Expand Epidel Platform into Non-Ophthalmic Space

Ripple Therapeutics is named Best WorkplacesTM for Start Ups

Ripple Therapeutics Appoints Jonathan Talamo, M.D., to Chair of the Board

Tom Reeves, President & CEO, presents during OIS Retina on July 13th at the Edison Ballroom NYC.

Ripple Therapeutics is a Great Place to Work

Ian Parrag PhD, Director R&D, presents One Engineer’s Path in Product Development Towards Controlled Drug Delivery at Canadian Biomaterials Society, May 27, 2022.

Ripple Therapeutics work on anti-fibrotic coatings has been published in Biomaterials.

Ike Ahmed, MD FRCSC, presents Preclinical Evaluation of RTC-1119, a Surface Eroding Intracameral Implant Composed Entirely of a Latanoprost acid Prodrug, for Long-term Intraocular Pressure Control,...

Ripple Therapeutics receives funding support to advance R&D efforts in ophthalmic therapeutics

Ripple Therapeutics Announces New Vice President, Operations

Ripple Therapeutic’s Tom Reeves to Present at BIO CEO & Investor Conference

Ripple’s President & CEO, Tom Reeves, presents at OIS Drug Deliver Forum, Dec 2, 2021

Kyle Battiston, PhD, Sr Engineer Mgr & Wendy Naimark, PhD, CTO, will be presenting at 2021 CRS Virtual Annual Meeting

2021 CRS Virtual Annual Meeting

Ripple’s President & CEO, Tom Reeves, presents at TSX Life Sciences Investor Day.

Ripple Therapeutics Research on Polymer-Free Drug Delivery Published in Nature Communications

New method can improve drug delivery in implants

Ripple Therapeutics Appoints Jonathan Talamo, M.D., to Board of Directors

Ripple Therapeutics Announces First Patient Treated in Phase II Trial Evaluating IBE-814 IVT in DME and RVO

Ripple’s CEO, Tom Reeves, presents at 2021 BIOTECanada Investor Summit

Sheardown Lab and Ripple Therapeutics receive NSERC grant to improve treatment for millions with eye disease

Ripple presents at 2021 OBIO Investment Summit, Canada’s Premier Health Science Investment Event

Tom Reeves, President & CEO of Ripple Therapeutics presents at Biotech Showcase

Ripple Therapeutics lead candidate attracts strategic investment and licensing partner

Ripple Therapeutics Secures Licensing Agreement and Series A Financing led by Théa Open Innovation

Ripple Presents at ARVO 2020

Ripple Series A Financing – watch this.

Ripple Therapeutics pursues financing for Phase 2 intravitreal implant trial and Epidel platform expansion

Interface Biologics Announces Spinout, Ripple Therapeutics

Fresenius Medical Care Receives FDA Breakthrough Device Designation for New Dialysis System to Prevent Blood Clotting Without the Use of Blood Thinners

Interface Biologics Announces Sale of Surface Modification Business to Evonik

IBI Poster at AUA 2019: In vitro evaluation of novel surface modifying molecules to prevent bacterial adhesion to urological devices

Pharmacokinetics and Pharmacodynamics of a Novel Dexamethasone Intravitreal Implant IBI Abstract Presented at ARVO 2019

Interface Biologics presents at OIS@AAO

Wendy Naimark, PhD, V.P. R&D speaks on Retinal Drug Delivery Solutions at OIS@ASRS2019

Overview of the Epidel® Prodrug Engineered Sustained Drug Delivery Platform
Wendy Naimark, CTO & Co-Founder

IBE-814 IVT Implants reduce treatment burden in subjects with DME and RVO due to sustained-release of dexamethasone: An analysis of the First-in-Human Phase 2 RIPPLE-1 trial

Efficacy and safety of a low dose dexamethasone implant for diabetic macular edema and retinal vein occlusion: Results of the First-In-Human Phase 2 RIPPLE-1 trial

Chronic ocular tolerability and pharmacodynamics of the RTC-1119 intracameral implant in normotensive beagle dogs