Shares of EyePoint Pharmaceuticals plunged about 70% after its lead eye drug missed the main goal of a pivotal trial, erasing nearly $1 billion in market value.
The Boston-area biotech’s drug Durayvu, an intraocular injection for wet age-related macular degeneration (AMD), failed to demonstrate non-inferiority to aflibercept (Regeneron’s Eylea) on best-corrected visual acuity across the roughly 400-patient LUGANO study — the first of two pivotal Phase 3 trials.
The company’s case
EyePoint attributed the miss to an “asymmetric cohort” of nine Durayvu-treated patients who experienced unexplained vision loss unrelated to wet AMD, and said a post-hoc analysis excluding that group would have met non-inferiority. It also highlighted durability: about three-quarters of patients went roughly eight months without supplemental anti-VEGF injections. CEO Jay Duker said the results still present “a compelling case,” with a potential FDA filing in the first half of 2027 pending the second trial, LUCIA.
Why it matters
Wet AMD is a leading cause of vision loss in older adults, and the treatment burden of frequent eye injections is a major drawback of current therapy — making long-acting options commercially attractive. But investors reacted to the endpoint miss, not the post-hoc math. Analysts at RBC Capital Markets said the LUCIA results “will be needed” for clarity, warning that a second failure would be “far more problematic.”