EYPT Stock Plunges 67% After Duravyu Misses Phase III Eye Disease Goal

EyePoint EYPT announced top-line results from the first of two pivotal late-stage clinical studies evaluating its investigational candidate, Duravyu (vorolanib intravitreal insert), in patients with wet age-related macular degeneration (wet AMD). The study did not meet its primary endpoint of non-inferiority on change from baseline in best corrected visual acuity (BCVA) at weeks 52 and 56 versus on-label Regeneron’s REGN Eylea (aflibercept) in the full dataset. However, Duravyu delivered favorable results across key secondary endpoints, including treatment burden, supplement-free rates, safety and anatomic control.

The phase III LUGANO Eylea-controlled, non-inferiority study enrolled both treatment-naïve and treatment-experienced patients with active wet AMD. Patients were randomized equally to receive either a 2.7mg dose of Duravyu every six months or on-label Eylea. Eylea is Regeneron’s blockbuster anti-VEGF drug, approved in the United States for several ophthalmic indications, including wet AMD.

EyePoint shares crashed 67% on Monday after it reported the phase III wet AMD study results, reflecting investor concern over the missed primary goal. The primary analysis was affected by an asymmetric cohort of nine patients, or about 4% of the 211-patient group, who experienced vision loss of at least 15 letters that EyePoint said was unrelated to wet AMD. None of the patients in the Eylea arm had similar vision loss. An ad hoc analysis excluding those nine patients showed Duravyu was non-inferior to REGN’s Eylea.

EYPT’s First Phase III Wet AMD Study Data in Detail

Despite missing the primary endpoint in the full dataset, the phase III LUGANO study achieved a 42% reduction in treatment burden compared with on-label Eylea, meeting the threshold for superiority. EyePoint said this reduction represented an average of two fewer injections through week 56 compared with the control arm. The result matters because wet AMD generally requires ongoing anti-VEGF treatment, adding to the burden on patients and physicians.

Year to date, shares of EyePoint have plummeted 73.3% against the industry’s 4.3% growth.

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Duravyu also demonstrated encouraging durability, as indicated by supplement-free treatment rates. About 76% of patients remained free of supplemental Eylea injections through week 32, while 94% received zero or one supplement during that period. Through week 56, 54% of patients remained supplement-free and 79% received zero or one supplemental injection. A pre-specified analysis of BCVA among supplement-free patients found Duravyu was non-inferior to on-label Eylea.

The candidate also demonstrated strong anatomic control through week 56. The mean difference in central subfield thickness between Duravyu and Regeneron’s Eylea was 4 microns at week 56. Among the 54% of Duravyu-treated eyes that remained supplement-free through week 56, the difference was just 3 microns versus the control arm. The findings support durable retinal disease control at the longer dosing interval.

Safety and tolerability remained favorable with repeat dosing. EyePoint reported no differences between Duravyu and REGN’s Eylea in cataracts, elevated intraocular pressure or intraocular inflammation. The company also reported no cases of insert migration, anterior chamber opacities, free-floating drug particles, retinal vasculitis or severe intraocular inflammation. The safety findings support continued evaluation of six-month dosing.

REGN co-develops Eylea with Bayer BAYRY. Per the terms of the agreement, Bayer holds the license to exclusive marketing rights of Eylea outside the United States and the profits from its sales are shared equally between REGN and BAYRY. Regeneron retains exclusive commercial rights to Eylea Injection in the United States.

EYPT’s Next Steps

The next major catalyst for EyePoint is top-line data from LUCIA, the second pivotal phase III wet AMD study. LUGANO and LUCIA are identical studies, and both are evaluating six-month redosing of Duravyu against on-label Eylea. EyePoint expects to report LUCIA top-line results in the fourth quarter of 2026. The phase III LUCIA study readout will help determine the path toward a potential regulatory filing.

EyePoint currently anticipates potentially submitting a new drug application for Duravyu in wet AMD in the first half of 2027, pending the LUCIA results. The company also plans to present additional LUGANO analyses, including subgroup data, at major retina conferences beginning with the Retina Society’s annual meeting in September 2026.

Beyond wet AMD, Duravyu is also being evaluated in diabetic macular edema (DME) in two late-stage studies. The phase III COMO and CAPRI studies of the candidate for DME are fully enrolled, with top-line data expected in the fourth quarter of 2027. The LUCIA and DME study readouts will be key to Duravyu’s longer-term development prospects.

EyePoint, Inc. Price and Consensus

EyePoint, Inc. price-consensus-chart | EyePoint, Inc. Quote

EYPT’s Zacks Rank & Stock to Consider

EyePoint currently carries a Zacks Rank #4 (Sell).

A better-ranked stock in the biotech sector is Amneal Pharmaceuticals AMRX, currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Over the past 60 days, earnings estimates for Amneal Pharmaceuticals have increased from $1.00 to $1.02 for 2026. Over the same period, earnings estimates increased from $1.12 to $1.21 for 2027. AMRX shares have risen 46.1% year to date.

Amneal Pharmaceuticals beat earnings in each of the trailing four quarters, delivering an average surprise of 32.82%.

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