EyePoint said its experimental drug to treat a serious eye disease that affects older people failed in a late-stage trial, sending its shares plunging over 65% in premarket trading on Monday.
The company was testing the drug, Duravyu, against approved treatment Eylea in patients with wet age-related macular degeneration, a leading cause of vision loss.
The trial failure deals a blow to EyePoint's ambitions to challenge Regeneron, whose blockbuster drug Eylea generated $4.39 billion in U.S. sales last year.
EyePoint said the trial missed its target of improving vision across the entire study group because results were skewed by a group of nine patients who experienced vision loss from causes unrelated to their eye disease.
Excluding these patients, Duravyu was just as effective as Eylea, EyePoint said.
Mizuho analyst Graig Suvannavejh said "investors are likely to discount" the company's explanation for the trial unless confirmed in a second study.
EyePoint said it 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.
TD Cowen analyst Tara Bancroft said the trial likely failed due to the nine patients, and warned that the drug's approval now hinges on a second study.
Duravyu reduced the overall treatment burden, cutting the average number of injections patients needed by 42% compared with the standard therapy, EyePoint said.
