EyePoint Pharmaceuticals shares collapsed by more than 70% Monday after the company's experimental eye implant, DURAVYU, missed the main goal of a late-stage trial testing it against Regeneron's blockbuster drug Eylea in patients with wet age-related macular degeneration. The stock fell to $4.16, wiping out more than $900 million in market value if the losses hold.
The Phase 3 trial, known as LUGANO, enrolled 211 patients and was designed to show DURAVYU was not meaningfully worse than Eylea at preserving vision, according to Reuters. On a full-dataset basis, the drug failed to clear that bar. EyePoint says the miss traces back to nine patients, roughly 4% of trial participants, who suffered vision loss from causes unrelated to wet AMD. When those patients were excluded, the company says DURAVYU performed as well as Eylea.
What makes that explanation harder to simply accept is what happened in the trial's control arm. Zero patients treated with standard Eylea experienced vision loss of 15 or more letters, according to FirstWord Pharma, even though historical clinical trials typically record a 3% to 5% vision-loss rate in Eylea control groups. That statistical anomaly is central to the dispute over whether EyePoint's subgroup explanation holds up or whether the trial simply came up short.
Wall Street Wants a Second Trial Before It Believes the Story
Mizuho analyst Graig Suvannavejh said investors are likely to discount EyePoint's explanation unless it is confirmed in a second study, per Reuters. Tara Bancroft made a similar point, saying DURAVYU's approval now hinges on that second trial. RBC Capital Markets analysts added that approval remains more challenging without two positive studies.
EyePoint's chief medical officer, Jay Duker, said the company still believes DURAVYU could win U.S. Food and Drug Administration approval on the strength of one successful trial, according to the same Reuters report. Duker also called the vision-loss result in the control arm highly unusual for an elderly population. EyePoint plans to file for FDA approval in the first half of 2027, but that filing depends on results from a second late-stage trial, called LUCIA, expected later this year.
There is precedent for single-trial approvals. Drugs from both Outlook Therapeutics and Apellis were approved despite one positive and one negative pivotal trial, and FDA guidance supports single-trial approvals when backed by additional evidence, per Reuters. Whether that precedent applies here will likely come down to what LUCIA shows.
Safety Data Held Up Even as the Main Goal Slipped
Away from the statistical confusion, DURAVYU's safety profile looked clean. Safety monitoring in the LUGANO trial found no occurrences of insert migration, retinal vasculitis, or severe intraocular inflammation, with rates of cataracts, elevated intraocular pressure, and ocular inflammation matching the control arm, according to Modern Retina. That distinction matters because it suggests the trial's setback was tied to statistical confounding in the vision-acuity measure rather than any toxicity issue with the drug or its delivery device.
DURAVYU delivers a drug called vorolanib through a bioerodible intravitreal insert every six months, aiming to cut down how often patients need eye injections. In the LUGANO trial, the drug cut patients' average injection burden by 42% compared with standard therapy. Durability numbers were also strong: 54% of DURAVYU-treated patients remained completely free of supplemental injections through Week 56, and 76% were supplement-free through Week 32, according to a company release carried by GlobeNewswire.
Vorolanib itself was licensed exclusively to EyePoint by Equinox Sciences, a Betta Pharmaceuticals affiliate, for ophthalmic uses outside Greater China. The drug is paired with EyePoint's Durasert E bioerodible matrix, which the GlobeNewswire release describes as releasing medication gradually over six months without leaving free-floating drug particles behind. Laboratory research presented in May offered a scientific rationale for why that combination might help: vorolanib blocks all VEGF receptors to inhibit abnormal blood vessel growth while also blocking IL-6/JAK1 signaling to reduce retinal inflammation, according to Modern Retina, addressing both major drivers of wet AMD damage.
A Crowded, High-Stakes Market for Fewer Eye Injections
EyePoint's earlier Phase 2 trial, called DAVIO 2, had raised expectations heading into this readout. That 161-patient study met its primary endpoint of non-inferiority to aflibercept while cutting patient injection burden by 85% to 89%, according to The Ophthalmologist.
The competitive landscape has also shifted. In April, the FDA approved Regeneron's high-dose Eylea HD, which extends dosing intervals up to five months for wet AMD and diabetic macular edema. Eylea generated about $4.4 billion in U.S. sales last year, underscoring what's at stake for any drug trying to unseat it. EyePoint tested DURAVYU directly against Eylea in this trial, and the outcome shows how high the bar remains.
EyePoint isn't limiting its ambitions to wet AMD. In July, the company completed enrollment of more than 480 patients across two global Phase 3 trials, COMO and CAPRI, evaluating DURAVYU for diabetic macular edema, with topline results expected in the fourth quarter of 2027, according to BioSpace. The global market for wet AMD therapies alone was valued at roughly $7.78 billion in 2025, with the United States generating nearly a third of that revenue.
The stakes extend well beyond one company's stock price. An estimated 200 million people worldwide live with age-related macular degeneration, and while wet AMD accounts for roughly 10% of total AMD cases, it causes about 90% of AMD-related central vision loss. For now, DURAVYU's path to market rests on whether the upcoming LUCIA trial can deliver the clean, unconfounded result that LUGANO did not.
