EyePoint Launches Pivotal Phase 3 Program for DURAVYU™ in Diabetic Macular Edema
AI-driven sustained-delivery therapy now advancing in two major retinal disease markets; new preclinical data highlights dual VEGF and IL-6 inhibition mechanism.
EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT) announced the initiation of its pivotal Phase 3 program for DURAVYU™ (vorolanib intravitreal insert) in diabetic macular edema (DME), with the first patient dosing anticipated in Q1 2026. The launch marks a major milestone for the company, positioning DURAVYU as the only tyrosine kinase inhibitor (TKI) in late-stage development for both wet age-related macular degeneration (AMD) and DME, two of the largest retinal disease markets globally.
Dual-Action Mechanism Targets VEGF and Inflammation
EyePoint also unveiled new preclinical data showing that vorolanib, the active ingredient in DURAVYU, inhibits interleukin-6 (IL-6)–mediated inflammation via Janus kinase (JAK) receptor blockade—particularly JAK-1—in addition to suppressing VEGF-mediated vascular permeability.
The finding supports prior clinical data from the Phase 2 VERONA trial, which demonstrated early and sustained vision improvements through six months, suggesting DURAVYU may act through a multi-mechanism pathway to address both vascular leakage and inflammation in DME.
“Despite the availability of anti-VEGF therapies, many DME patients continue to lose vision,” said Dr. Ramiro Ribeiro, Chief Medical Officer at EyePoint. “Our new data reinforce that DURAVYU not only blocks VEGF, but also inhibits IL-6–mediated inflammation. This positions DURAVYU as a potential six-month, multi-MOA treatment option designed to improve outcomes and reduce treatment burden.”
Pivotal Program Design and Timeline
Following a positive End-of-Phase-2 meeting with the U.S. FDA, EyePoint’s pivotal program will consist of two identical non-inferiority Phase 3 trials, named COMO and CAPRI, which together will form the company’s registrational package.
Each study will enroll about 240 patients—both treatment-naïve and previously treated—and compare DURAVYU 2.7 mg with on-label 2 mg aflibercept. Patients will receive injections every six months, with the primary endpoint being change in best corrected visual acuity (BCVA) at weeks 52 and 56 (blended).
The company expects top-line data in 2027, following interim three-month readouts in Q2 2026.
Participating sites include leading retinal research institutions such as University of Miami Health System, Texas Back Institute, Advocate Health, Northwestern Medicine, Scripps Health, Keck Medicine of USC, and Johns Hopkins University.
Expert Perspective and Clinical Need
DME remains one of the leading causes of vision loss among diabetic patients, with an estimated 28 million people affected worldwide. Although anti-VEGF injections are standard of care, many patients experience persistent disease activity and require frequent treatments.
“Inflammation plays a critical role in DME, and we urgently need therapies that target both VEGF and inflammatory pathways,” said Dr. Roger Goldberg, Vitreoretinal Surgeon at Bay Area Retina Associates and Co-Founder of Emmetrope Ophthalmics. “DURAVYU’s dual mechanism, favorable safety profile, and extended dosing interval could meaningfully reduce treatment burden and improve long-term outcomes.”
A Six-Month Sustained-Release Option
EyePoint’s proprietary sustained-delivery insert provides consistent, localized dosing for at least six months following a single injection. This could significantly extend dosing intervals compared to current short-acting anti-VEGF biologics, corticosteroids, or laser therapies, which can require monthly administration.
The company plans to present its IL-6/JAK inhibition data at the Eyecelerator meeting at AAO 2025, reinforcing its scientific leadership in sustained-release ocular drug delivery.
