EyePoint’s Duravyu fails late-stage trial; FDA approval path uncertain
EyePoint said its Duravyu failed a late-stage trial to show it was not meaningfully worse than Eylea in preserving vision, with unusual cases in the Duravyu group. Approval depends on the pivotal study and a potentially tougher single-trial path. Shares fell to about $4.16, and the company plans an FDA filing in early 2027 pending a second late-stage trial.