EyePoint Stock Plummets on Mixed Primary Data From Blindness Drug Study

EyePoint Inc. (NASDAQ:EYPT) stock plunged on Monday after the company released topline results from its pivotal Phase 3 LUGANO clinical trial evaluating DURAVYU for the treatment of wet age-related macular degeneration.

While key secondary endpoints showed significant clinical progress, the study failed to meet its primary visual acuity endpoint due to a confounding patient subgroup.

LUGANO Trial Visual Acuity Outcomes

The trial evaluated DURAVYU against an on-label 2 mg aflibercept control arm. The primary endpoint of baseline visual acuity changes was impacted by a 4% asymmetric cohort of nine patients who experienced non-wet AMD vision loss.

An ad hoc analysis excluding these patients showed DURAVYU was non-inferior to aflibercept. Meanwhile, zero control group patients lost 15 or more letters, outperforming historical trial rates of 3% to 5%.

Secondary Endpoints And Safety Performance

DURAVYU met crucial secondary endpoints, achieving a superior 42% reduction in treatment burden versus control, equating to two fewer injections on average through Week 56.

Additionally, 76% of DURAVYU patients were supplement-free through Week 32, while 54% remained supplement-free through Week 56 with consistent anatomic control.

The insert proved safe and well-tolerated upon repeat dosing. Cataract, elevated intraocular pressure, and inflammation rates matched the control group, with no occurrences of insert migration, retinal vasculitis, or severe intraocular inflammation.

Regulatory Strategy And Pipeline Timeline

EyePoint expects topline data from its second Phase 3 wet AMD trial, LUCIA, in the fourth quarter of 2026.

The company targets a potential New Drug Application filing for DURAVYU in the first half of 2027. Topline data from Phase 3 DME trials, COMO and CAPRI, are scheduled for the fourth quarter of 2027.

EYPT Price Action: EyePoint shares were down 70.24% at $3.97 at the time of publication on Monday. The stock is trading at a new 52-week low, according to Benzinga Pro data.

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