EyePoint Pharmaceuticals began its pivotal Phase 3 studies for DURAVYU in diabetic macular edema (DME) by dosing the first patient on March 2, 2026. The company’s announcement marks the start of enrollment in the COMO and CAPRI trials, each designed to enroll roughly 240 participants.
Both trials are randomized, double‑masked, and use aflibercept as the active‑control comparator in a non‑inferiority framework. Patients in the DURAVYU arm receive a single intravitreal implant that releases drug for at least six months, with re‑dosing scheduled every six months from Day 1 of the study.
DURAVYU is a sustained‑release tyrosine‑kinase inhibitor that targets both VEGF‑mediated vascular leakage and IL‑6–driven inflammation. The dual‑mechanism approach positions the drug as a potential first‑in‑class therapy that could reduce the treatment burden for patients who currently require frequent anti‑VEGF injections.
The initiation of these trials brings EyePoint closer to the regulatory data needed for a DME approval, with topline results expected in the second half of 2027. The company’s focus on a single high‑potential asset, coupled with a projected cash runway that extends through Q4 2027, underpins its ability to fund the program through the critical data readouts.
CEO Jay Duker described the progress as “tremendous” and emphasized confidence in DURAVYU’s differentiated clinical profile, while Chief Medical Officer Ramiro Ribeiro highlighted the program’s potential to offer a safe, durable treatment option for patients with DME.
Financially, EyePoint reported a Q3 2025 net revenue of $1 million, down from $10.5 million a year earlier, and a net loss of $59.7 million ($0.85 per share). Despite the losses, the company’s cash runway is sufficient to support operations through the key data milestones in 2026 and 2027.
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