Eyepoint’s experimental eye drug fails primary endpoint in Phase 3 study

By the Editorial Team · Tuesday, August 18, 2026

Eyepoint Pharmaceuticals announced that its experimental drug duravyu did not meet the primary endpoint in a Phase 3 trial for wet age-related macular degeneration, failing to demonstrate vision improvement equivalent to the current standard treatment, Eylea. This setback jeopardizes Eyepoint’s regulatory approval plans and caused a sharp decline in its stock, while highlighting ongoing challenges in developing less frequent injection therapies for wet AMD.

Eyepoint Pharmaceuticals announced on Monday that its experimental drug duravyu failed to meet the primary endpoint in a Phase 3 clinical trial aimed at treating wet age-related macular degeneration (wet AMD). The study, named LUGANO, evaluated whether duravyu could maintain vision with fewer injections compared to the current standard treatment, Eylea, developed by Regeneron Pharmaceuticals.

Duravyu is designed to be administered via two eye injections over one year, while Eylea typically requires six injections during the same period. The trial measured visual acuity improvements by tracking how many additional letters patients could read on a standardized eye chart after treatment. Participants receiving duravyu were able to read nearly four more letters than those treated with Eylea, but the difference in vision improvement was not statistically equivalent to that of the standard therapy, causing the study to fall short of proving noninferiority.

Eyepoint attributed the trial's failure primarily to nine patients in the duravyu group who experienced significant asymmetric vision loss—labeled as a decrease of more than 15 letters on the eye chart—due to reasons unrelated to wet AMD. In contrast, patients treated with Eylea showed better-than-expected overall vision gains during the trial. Following an ad hoc analysis that excluded these nine outlier patients, Eyepoint reported duravyu achieved statistical equivalence to Eylea in terms of visual outcomes.

Jay Duker, CEO of Eyepoint, stated during a conference call that the results still underlined duravyu’s potential to improve treatment options for wet AMD, emphasizing the drug’s clinical relevance despite the setback. However, the initial failure to meet the primary endpoint has put the company’s regulatory approval plans in jeopardy.

The news triggered a sharp decline in Eyepoint’s stock price, which dropped by approximately 67 percent to $4.87 during Monday’s trading session. Conversely, shares of Bedford-based Ocular Therapeutix, a competitor developing its own eye treatment for wet AMD expected to be submitted for FDA review later this year, rose in response to the trial results.

Both Eyepoint and Ocular Therapeutix are working on therapies intended to reduce the frequency of injections needed to maintain vision in patients with wet AMD, a leading cause of age-related blindness. The outcome of the LUGANO study signals the challenges faced by companies developing new treatment paradigms that aim to improve patient convenience without compromising efficacy.

This article was reported by synthesizing coverage from multiple independent news outlets to present a balanced, unbiased account. Read about our editorial standards. Spotted an error? Let us know.