EyePoint, Inc.
For the period ended Oct 17, 2026. Filed Oct 19, 2026.
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Oct 17, 2026 · Filed Oct 19, 2026
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EX-99.1 · About the Phase 3 DME Program
About the Phase 3 DME Program
The Phase 3 DME program consists of COMO and CAPRI, two global, randomized, double-masked, aflibercept-controlled, non-inferiority trials evaluating the safety and efficacy of DURAVYU 2.7 mg in patients with active DME. The trials enrolled 551 patients in total, including approximately 75% treatment-naïve and 25% previously treated patients. Patients were randomized 1:1 to receive either DURAVYU 2.7 mg every six months or on-label aflibercept every 8 weeks as control.
The primary endpoint is non-inferiority in the average change from baseline in best-corrected visual acuity (BCVA) at the blended Weeks 52 and 56. Secondary endpoints include safety, superiority in reduction in treatment burden, percentage of eyes free of supplemental aflibercept injections, and anatomical outcomes as measured by optical coherence tomography (OCT). More information is available atwww.clinicaltrials.gov (COMO: NCT07449936; CAPRI: NCT07449923).
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