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