EyePoint DURAVYU Phase 3 Wet AMD Trials Get Third Positive DSMC Recommendation; Topline Data Due Mid-2026

EyePoint announced that the independent Data Safety Monitoring Committee (DSMC) completed its third scheduled review of the pivotal Phase 3 program evaluating DURAVYU for wet age-related macular degeneration (wet AMD) and recommended that both the LUGANO and LUCIA trials continue as planned with no protocol modifications. Topline data from LUGANO are on track for mid-2026, with LUCIA readout expected a few months later.

The DSMC, an independent panel of experts in ophthalmology and biostatistics, reviewed interim masked safety data from the Phase 3 trials as of May 2, 2026. The committee reported a continued favorable safety profile for DURAVYU, consistent with safety observed in over 190 patients across four previously completed clinical trials. All active patients in the treatment arm have reached the Week 32 visit, during which patients received their second DURAVYU dose, and over 35% have also received their third planned dose at Week 56. DSMC meetings are scheduled every six months per protocol, and this was the last anticipated meeting ahead of topline data.

"This continued independent validation, together with the favorable safety profile observed across four completed clinical trials, reinforces our confidence as we approach Phase 3 topline data beginning in mid-2026," said the company's Chief Medical Officer. "If successful, we believe that DURAVYU is well-positioned to be a first and best-in-class therapy with the potential to establish a new treatment paradigm."

LUGANO and LUCIA are identical, randomized, double-masked, aflibercept-controlled, non-inferiority Phase 3 trials assessing DURAVYU in patients with active wet AMD, including both treatment-naïve and treatment-experienced patients. Enrollment is complete in both trials with over 900 patients. Patients are randomized 1:1 to receive either DURAVYU 2.7 mg every six months or on-label aflibercept as control. The trials are the only sustained-release wet AMD pivotal Phase 3 trials evaluating 6-month redosing in both trials over two years. DURAVYU is delivered via a standard intravitreal injection. The primary endpoint 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 measured by optical coherence tomography.

EyePoint's Chief Financial Officer outlined the regulatory and commercial strategy in a corporate presentation. The FDA's safety expectations for filing require 300 evaluable patients at the go-to-market dose and interval, which the company expects to exceed using the two pivotal trials. Both studies are two-year trials, but the non-inferiority endpoint is at 56 weeks, and EyePoint plans to submit an NDA based on one-year safety and efficacy, followed by an sNDA with two-year safety. The non-inferiority margin is -4.5 letters, and the control arm must behave consistently with the data used to establish that margin, one reason the company is using on-label aflibercept. The company described "unlimited dosing" on-label as a potential competitive advantage.

EyePoint also provided updates on manufacturing and commercialization. Its facility in Northbridge, Massachusetts, is "up and running," with work focused on meeting FDA chemistry, manufacturing, and controls expectations ahead of a potential NDA submission. Commercially, the company plans to launch DURAVYU in the United States on its own, estimating retina can be addressed with about 70 sales representatives plus supporting infrastructure. The company ended 2025 with $300 million in cash and reiterated a cash runway into Q4 2027.

DURAVYU is an investigational sustained-delivery treatment combining vorolanib, a small-molecule tyrosine kinase inhibitor, with EyePoint's Durasert E technology. The solid, fully bio-erodible insert is delivered via intravitreal injection and is designed to control drug release over time. Each insert is approximately 94% drug and 6% matrix, with a target of at least six-month dosing in wet AMD and DME, with redosing every six months in the trials. The company is also beginning Phase III development in diabetic macular edema (DME). Wet AMD is a leading cause of vision loss and irreversible blindness in people over the age of fifty, and the current standard of care is dosed on average every two months in the United States under a treat-and-extend protocol.