Eyepoint Pharmaceuticals, Inc. (NASDAQ: EYPT) has received a positive recommendation from the independent Data Safety Monitoring Committee (DSMC) for its pivotal phase 3 trials for Duravyu™ in the treatment of wet age-related macular degeneration (wet AMD). As of the September 29, 2025 data cutoff for the DSMC review, all patients across the Lugano and Lucia trials reached the week 8 visit, with approximately 25% of those patients receiving their second planned dose of Duravyu at week 32.
The DSMC recommended that both the Lugano and Lucia trials continue as planned, with no modifications to the protocol, which indicates a favorable safety profile observed across its development history. The trials, which are randomized, double-masked, aflibercept controlled, non-inferiority phase 3 trials, have enrolled over 900 patients. Patients were randomized 1:1 to receive either Duravyu 2.7mg every six months or aflibercept on-label as control.
The primary endpoint of the phase 3 pivotal trials is non-inferiority in the average change in best-corrected visual acuity (BCVA) at weeks 52 and 56 compared to baseline. Secondary endpoints include safety, reduction in treatment burden, percentage of eyes free of supplemental aflibercept injections, and anatomical results as measured by optical coherence tomography (OCT).
Wet AMD is a leading cause of vision loss and irreversible blindness in people over the age of fifty. Challenges exist with the current standard-of-care, which is dosed on average every two months in the United States under a treat-and-extend protocol. Duravyu™ (vorolanib intravitreal insert) is being developed as a potential sustained-delivery treatment and combines vorolanib in next-generation durasert e™ technology. Vorolanib is a differentiated and patent-protected tyrosine kinase inhibitor, showing no ocular safety signals noted in four prior trials.
The phase 3 pivotal program for Duravyu is evaluating every six-month dosing, potentially providing a flexible label for physicians. Eyepoint Pharmaceuticals, Inc. is committed to developing and commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases.
The company's lead product candidate, Duravyu™, is currently being evaluated in phase 3 pivotal trials for wet age-related macular degeneration with expected topline data beginning in mid-2026. First patient dosing in the pivotal phase 3 clinical trials in diabetic macular edema is expected in the first quarter of 2026. Eyepoint is headquartered in Watertown, Massachusetts, with a commercial manufacturing facility in Northbridge, Massachusetts.
Duravyu™ has been conditionally accepted by the FDA as the proprietary name for EYP-1901 and is an investigational product; it has not been approved by the FDA. As a result of these announcements, the company's shares have moved 0.04% on the market, and are now trading at a price of $13.965. For the full picture, make sure to review EyePoint Pharmaceuticals's 8-K report.
