EyePoint Initiates Pivotal Phase 3 Trial for DURAVYU in Macular Edema
Advances potential six-month treatment for Diabetic Macular Edema, targeting a multi-billion dollar retinal disease market and drawing positive analyst outlook.
EyePoint Pharmaceuticals (NASDAQ: EYPT) has launched a pivotal Phase 3 clinical program for its novel drug candidate, DURAVYU™, targeting the treatment of Diabetic Macular Edema (DME), a leading cause of vision loss among people with diabetes. The move advances the therapy into late-stage trials for one of the largest retinal disease markets, a significant step toward potential commercialization.
The initiation of the Phase 3 program, which will include two identical trials named COMO and CAPRI, follows promising data from earlier studies. , the first patient is expected to be dosed in the first quarter of 2026. This places DURAVYU in Phase 3 development for two major indications, the other being wet age-related macular degeneration (wet AMD).
DURAVYU, a vorolanib intravitreal insert, is designed for sustained drug delivery over six months, potentially offering a significant advantage over existing treatments that require more frequent injections. This reduced treatment burden is a key focus for clinicians and patients. Preclinical data suggests the drug's active ingredient, vorolanib, inhibits both VEGF-mediated vascular leakage and inflammation, addressing two key pathways of the disease.
The strategic development has been met with positive sentiment from Wall Street. , with an average price target of $33.00, suggesting significant upside from its current trading level. Mizuho recently raised its price target to $28.00, citing the drug's progress even as the company navigates the typical financial challenges of a development-stage biotech firm.
The pivotal trials will enroll approximately 240 patients each and will compare DURAVYU to the current standard-of-care, aflibercept, with a primary endpoint measuring visual acuity changes at 52 and 56 weeks. , providing a clear regulatory road forward.
With enrollment for its wet AMD Phase 3 trials already complete and topline data expected in mid-2026, EyePoint is positioning DURAVYU as a potential first-in-class tyrosine kinase inhibitor (TKI) for two of the most prevalent retinal diseases. This latest milestone in the DME space further solidifies its path toward addressing a critical unmet need in eye care.