Eyepoint Pharmaceuticals, Inc. (NASDAQ: EYPT) has completed the enrollment of its phase 3 pivotal program with the full enrollment of the Lucia trial, the second of two identical ongoing pivotal non-inferiority trials evaluating Duravyu™ for the treatment of wet age-related macular degeneration (wet AMD). The Lucia trial enrolled and randomized over 400 patients in seven months, making Duravyu one of the fastest enrolling phase 3 pivotal programs in wet AMD.
Over 800 patients have been enrolled across the Lugano and Lucia trials of Duravyu, representing one of the fastest enrolling phase 3 pivotal programs for wet AMD. The interim analysis by an independent Data Safety Monitoring Committee (DSMC) confirmed no changes to the phase 3 protocol and recommended continuation of the trial as planned.
Topline 56-week data for Lugano is expected in mid-2026, with Lucia to closely follow.
The safety profile observed in Lugano and Lucia is consistent with previous Duravyu clinical trials, with no Duravyu-related ocular or systemic serious adverse events observed. The robust safety and efficacy data from the Davio 2 phase 2 clinical trial support the Lugano and Lucia trials.
Both trials are randomized, double-masked, aflibercept controlled, non-inferiority phase 3 trials assessing the efficacy and safety of Duravyu in patients with active wet AMD, including treatment-naive and treatment-experienced patients. The primary endpoint of the phase 3 pivotal trials is the average change in best corrected visual acuity (BCVA) at weeks 52 and 56 versus baseline.
Duravyu is designed to be administered intravitreally in a pre-loaded syringe injector and deliver a daily therapeutic dose for at least six months. It combines vorolanib in the Durasert E™ technology, a bioerodible sustained release insert with a matrix designed to prevent free-floating drug particles and contains no peg or plga.
The phase 3 pivotal program follows a well-established regulatory approval pathway with a patient-centric non-inferiority design comparing Duravyu to on-label standard of care to inform real-world treatment practices. Duravyu is also being evaluated for the treatment of diabetic macular edema (DME).
Eyepoint Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company 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 two phase 3 pivotal trials for wet AMD with topline data anticipated in 2026.
The company 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, an investigational product that has not been approved by the FDA. The market has reacted to these announcements by moving the company's shares -0.6% to a price of $9.97. For more information, read the company's full 8-K submission here.
