Eyepoint Pharmaceuticals, Inc. (NASDAQ: EYPT) has announced the initiation of its pivotal phase 3 program for Duravyu™, a potential sustained-delivery treatment for diabetic macular edema (DME). The first patient dosing in the pivotal phase 3 DME trials is anticipated in the first quarter of 2026. This significant development follows a positive end of phase 2 meeting with the FDA, setting the stage for the advancement of Duravyu™ in addressing the unmet medical needs in DME.
The pivotal phase 3 program consists of two identical non-inferiority trials * "COMO" and "CAPRI" * with each trial enrolling approximately 240 patients. The primary endpoint for the trials is the change from baseline in best corrected visual acuity (BCVA) at weeks 52 and 56, compared to the on-label 2mg aflibercept.
The new preclinical data demonstrates that Duravyu™ has the potential to be a multi-mechanism of action (MOA) treatment, inhibiting both VEGF via inhibition of all VEGFRs and IL-6 signaling via JAK receptor blockage. This finding is significant as IL-6 is a pro-inflammatory cytokine observed at significantly higher levels in patients with DME and wet AMD compared to healthy individuals.
The data also shows that up to two-thirds of patients still have active DME after anti-VEGF loading, underscoring the multifactorial nature of the disease and the suboptimal efficacy associated with a single-mechanism approach. Vorolanib, the active drug in Duravyu™, is a potent and selective tyrosine kinase inhibitor (TKI) that inhibits all VEGF and JAK receptors, particularly JAK-1. The sustained drug delivery provided by Duravyu™ offers consistent daily dosing with receptor inhibition for at least six months after a single injection.
The phase 2 Verona trial in DME demonstrated early and sustained improvements in vision and anatomy compared to aflibercept, further highlighting the potential clinical utility of Duravyu™ in addressing the multifactorial nature of DME.
Diabetic macular edema (DME) is the leading cause of vision loss in people with type 1 and type 2 diabetes, affecting approximately 28 million people worldwide. The current standard of care for DME includes intravitreal injections of short-acting anti-VEGF biologics, corticosteroids, or laser photocoagulation, which can become burdensome due to the longevity of the disease.
Duravyu™ (vorolanib intravitreal insert) aims to provide a potential sustained-delivery treatment for patients suffering from serious retinal diseases, combining vorolanib in next-generation Durasert E™ technology. The EYPT team is committed to developing and commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases, with Duravyu™ being a key product candidate in their pipeline.
Eyepoint Pharmaceuticals is headquartered in Watertown, Massachusetts, and is dedicated to partnering with the retina community to improve patient lives while creating long-term value. The company has a strong track record, with four approved drugs over three decades and tens of thousands of eyes treated with Eyepoint innovation. Today the company's shares have moved -1.7% to a price of $13.34. Check out the company's full 8-K submission here.
