EyePoint Defends DURAVYU Following LUGANO Phase III Trial Failure

EyePoint Pharmaceuticals is attempting to salvage its lead drug candidate, DURAVYU, by characterizing a failed Phase III trial as a statistical anomaly. The company is now focusing on secondary endpoints and a second upcoming study. The LUGANO trial, which evaluated the drug for wet age-related macular degeneration (wet AMD), missed its primary endpoint of best-corrected visual acuity (BCVA) change when measured against the standard-of-care aflibercept.

"Only 0.5% of the control eyes lost 15 or more letters. Just a very unusual result... it would be hard to believe that we’re going to see that lower rate of 15 letter losers in the next trial," said Jay Duker, EyePoint’s president and chief executive, at a recent Citi summit.

Explaining the Clinical Discrepancy

Management attributes the primary endpoint failure to an unusual cohort of patients. According to company data, 4% of participants receiving DURAVYU (9 of 211) experienced severe vision loss unrelated to the progression of wet AMD, a phenomenon that did not occur in the control arm.

The company highlighted secondary endpoints as evidence of the drug's potential. The trial showed a 42% reduction in treatment burden for patients, with 88% of those treated with DURAVYU requiring only two to four injections over the course of the year. In wet AMD, where frequent intravitreal injections are standard, a decrease in treatment frequency is a factor for commercial adoption and patient adherence.

Regulatory Path and Precedents

EyePoint executives are looking toward the upcoming LUCIA trial to establish the efficacy profile required for regulatory approval. The company maintains that a single negative study does not preclude a successful New Drug Application (NDA) if subsequent data demonstrates safety and efficacy.

"In ophthalmology, there are several precedents of submissions and drugs that got approved with one study being negative and then the other study being positive. Recent examples are Apellis with SYFOVRE and Outlook Therapeutics with a drug for wet AMD... they look at the totality of the data," said Ramiro Ribeiro, the company’s chief medical officer.

What Is at Stake for EyePoint

The company expects to report results from the LUCIA pivotal trial in Q4 2026. These results will determine the feasibility of an FDA NDA submission, which the firm is targeting for the first half of 2027. The outcome of the second trial is necessary for EyePoint to demonstrate that the LUGANO results were an outlier to satisfy regulators and maintain the DURAVYU program.