EyePoint’s Duravyu Misses Primary Goal in Late-Stage Wet AMD Trial

On August 17, EyePoint announced that its investigational tyrosine-kinase inhibitor duravyu failed to meet the primary endpoint in the Phase 3 “Lugano” trial in wet age-related macular degeneration (AMD). The study enrolled roughly 400 patients and compared duravyu with Regeneron’s aflibercept (Eylea). The primary measure—average change in best-corrected visual acuity (BCVA) after two years—was not achieved. Nine of 211 duravyu recipients (about 4%) experienced vision loss of 15 letters or more from causes unrelated to AMD; no such loss occurred in the aflibercept arm. When those nine patients are excluded, duravyu performed as well as aflibercept, according to the company. The miss triggered a stock plunge of more than 70%, with share prices reported at $4.16 and $4.28 in early trading.

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Duravyu is designed to reduce injection frequency, a major burden of anti-VEGF therapy. EyePoint highlighted a 42 % reduction in treatment burden versus standard therapy in secondary analyses. Competitor Ocular Therapeutix is pursuing a similar TKI candidate, axpaxli, which recently reported a successful Phase 3 primary endpoint and saw its shares rise over 6 % to $10.72. Both firms aim to challenge the blockbuster aflibercept market, which generated about $4.4 billion in U.S. sales last year.

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CEO Jay Duker described the nine vision-loss cases as “highly unusual” for an elderly cohort and maintained confidence that duravyu could still obtain FDA approval based on a single positive pivotal trial, citing precedents such as approvals for drugs from Apellis and Outlook Therapeutics. Mizuho analyst Graig Suvannavejh warned that investors may discount the company’s post-hoc explanation unless confirmed in a second study. TD Cowen analyst Tara Bancroft noted that regulatory approval now hinges on the outcome of the identically designed “Lucia” trial, with topline data expected later this year. RBC Capital Markets called the path “more challenging” without two positive studies.

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Sources differ on the exact post-miss share price: one report lists EyePoint’s stock at $4.16, while another cites $4.28. Neither source provides the precise number of patients achieving the secondary injection-burden reduction, only the percentage figure. Detailed BCVA change values for each arm were not disclosed.

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• “The secondaries reinforce duravyu’s differentiated durability and safety,” — Mizuho, analyst

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