EyePoint, Inc. (EYPT) announced that the first patients have been dosed in its two pivotal Phase 3 trials, COMO and CAPRI, evaluating DURAVYU (vorolanib intravitreal insert) for diabetic macular edema.
This milestone marks the start of late-stage testing for what could become the first tyrosine kinase inhibitor approved for this vision-threatening condition.
Diabetic macular edema (DME), a leading cause of vision loss in people with diabetes, occurs when fluid leaks into the macular, blurring central vision. Current treatments often require frequent injections, creating a heavy burden for patients.
DURAVYU is designed to deliver therapy through Eyepoint's bioerodible insert Durasert E, targeting both VEGF-driven leakage and IL-6-related inflammation, with dosing intervals of at least six months.
The Phase 3 COMO and CAPRI trials are global, randomized, double-masked studies enrolling about 240 patients each, comparing DURAVYU to aflibercept, the current standard of care. The primary goal is to measure improvements in vision over one year, with secondary endpoints assessing safety and reduced treatment burden.
EyePoint expects topline results from the DME program in the second half of 2027, while parallel Phase 3 trials of DURAVYU in wet age-related macular degeneration are already underway, with data anticipated beginning in mid-2026.
EYPT has traded between $3.91 and $19.11 over the past year. The stock closed Friday's session at $17.56, down 1.68%. In premarket trading Monday, the stock is down 1.14% to $17.36.
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