EyePoint's drug for age-related eye disease fails late-stage trial, shares tank
EYPT•Late-stage trial misses main goal
EyePoint said its experimental drug missed the main goal in a late-stage trial as a few patients lost vision from causes unrelated to the targeted disease, sending its shares tumbling more than 70% on Monday.
The company was testing its drug Duravyu against Eylea by Regeneron in patients with wet age-related macular degeneration (AMD), a leading cause of vision loss among older adults. The miss deals a blow to EyePoint's ambitions to challenge the blockbuster eye drug that generated about $4.4 billion in U.S. sales last year.
Analysts say approval path looks harder
Mizuho analyst Graig Suvannavejh said "investors are likely to discount" the company's explanation for the trial unless confirmed in a second study. The drug's approval now hinges on that trial, said TD Cowen analyst Tara Bancroft.
RBC Capital Markets' analysts said it remains "more challenging" without two positive studies.
Vision-loss cases complicate the result
EyePoint couldn’t establish that Duravyu was not meaningfully worse than Eylea at preserving vision. Nine of 211 patients, about 4% of the test participants, suffered vision loss unrelated to wet AMD.
There were no such instances among patients administered Eylea. This was "highly unusual" for an elderly population, EyePoint CEO Jay Duker said on an analyst call.
Excluding those patients, Duravyu performed as well as Eylea, the company said.
EyePoint still targets FDA filing in 2027
Duker said the company still believes Duravyu could win an approval from the U.S. FDA, on the strength of one successful trial. The CEO cited precedents, including drugs from Apellis and Outlook Therapeutics that were approved despite one positive and one negative pivotal trial, along with updated FDA guidance supporting single-trial approvals backed by additional evidence.
