EyePoint's Wet AMD Drug Duravyu Fails Key Late-Stage Trial
Bengaluru: 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.
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.
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.
EyePoint's stock fell to $4.16 in morning trading. It would lose over $900 million in market value if losses hold.
A SINGLE-TRIAL PATH TO VICTORY?
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.
RBC Capital Markets' analysts, however, said it remains "more challenging" without two positive studies.
EyePoint plans to file for U.S. FDA approval in the first half of 2027, pending results from a second late-stage trial expected later this year.
Duravyu cut patients' average injection burden by 42% compared with standard therapy, the company said.
