EyePoint Pharmaceuticals (EYPT) saw its stock collapse by more than 70% on Monday after its drug-device combination Duravyu stumbled in its first of two phase 3 trial readouts this year.
The company is testing Duravyu as a challenger to Regeneron Pharmaceuticals’ (REGN) Eylea, known generically as aflibercept, which generated $4.4 billion in US sales in 2025.
Duravyu failed to demonstrate non-inferiority to Eylea on a primary endpoint measuring best-corrected visual acuity at 52 and 56 weeks in the phase 3 study.
EyePoint responded by turning to an ad hoc analysis in an attempt to rescue the tyrosine kinase inhibitor’s standing in the trial results.
The company identified nine patients out of a cohort of 211 on Duravyu, roughly 4%, who experienced vision loss entirely unrelated to wet age-related macular degeneration during the trial.
No such vision loss occurred in the Eylea arm, a finding that EyePoint CEO Jay Duker, M.D., described as “highly unusual” given historical non-wAMD vision loss rates of 3% to 5% in previous phase 3 trials.
EyePoint argues these nine patients skewed the overall results and that removing them in an ad hoc analysis demonstrated Duravyu’s non-inferiority to Eylea.
Duravyu’s ocular implant is designed to deliver the drug vorolanib in a sustained-release manner for at least six months, aiming to reduce the injection burden faced by wAMD patients on current treatments.
On secondary endpoints, the treatment performed well, cutting injection burden by 42% and delivering approximately two fewer injections on average compared to those receiving Eylea.
The phase 3 miss casts a significant shadow over the company’s second late-stage Lucia trial, which is expected to produce results this autumn and is now under intense scrutiny from investors and analysts alike.
Citi analyst Yigal Nochomovitz suggested “extremely bad luck” could be a legitimate explanation for the poor outcome, pointing to precedent within the sector for regulatory approval following one failed and one successful trial.
“There is precedent in ophthalmology for one failed trial and one successful trial to be sufficient for approval,” Nochomovitz said in an Aug. 17 note, adding, “While we reflect higher LUCIA risk, we see a possible path forward in wAMD.”
William Blair analysts said the totality of data still suggests Duravyu offers “clinical benefit,” and that “one clean positive readout” could be sufficient to support an eventual FDA approval.
Monday’s dramatic share price decline benefited rival Ocular Therapeutix, whose stock climbed by as much as 11% as investors reassessed the competitive landscape in the wAMD treatment space.
This is not the first setback for Duravyu, which missed its primary endpoint in a study of patients with nonproliferative diabetic retinopathy in 2024, raising earlier questions about the asset’s broader potential.
Meanwhile, Eylea itself faces mounting competitive pressure from biosimilars eroding its market dominance, with quarterly sales dropping below $1 billion for the first time in eight years during 2026.
Eylea was originally approved for wAMD back in 2011 and rapidly became one of the most commercially successful ophthalmology drugs in history, but that position is clearly under sustained challenge.
The central question hanging over EyePoint now is what caused the non-wAMD vision loss in the Duravyu arm, and whether the Lucia trial will deliver the clean data needed to keep an approval pathway alive.