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). The DSMC has recommended no changes in protocol for the Lugano and Lucia clinical trials, as the masked safety data continues to show no safety signals, consistent with previous clinical trials for Duravyu.
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 during which patients in the Duravyu arms received their initial Duravyu dose, and approximately 25% of those patients received their second planned dose of Duravyu at week 32.
The Lugano and Lucia 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, with over 900 patients enrolled. Patients are randomized 1:1 to receive either Duravyu 2.7mg every six months or aflibercept on-label as control.
Duravyu is a solid bioerodible insert designed to release a constant therapeutic dose for at least six months and is administered via a routine intravitreal injection with a sterile, prefilled syringe injector. 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.
The Wet AMD phase 3 pivotal program is evaluating every six-month dosing of Duravyu, potentially providing a flexible label for physicians. 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.
Eyepoint Pharmaceuticals, Inc. is committed to developing and commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases. Their lead product candidate, Duravyu, is currently being evaluated in phase 3 pivotal trials for Wet AMD, with expected topline data beginning in mid-2026. The company is also advancing Duravyu for the treatment of diabetic macular edema (DME) with the first patient dosing in phase 3 trials expected in the first quarter of 2026.
The press release did not provide specific metrics or comparative data from the previous period for the trials or the company's financial performance. Following these announcements, the company's shares moved 6.28%, and are now trading at a price of $13.96. For the full picture, make sure to review EyePoint Pharmaceuticals's 8-K report.
