EyePoint Pharmaceuticals has dosed the first patients in 2 global phase 3 clinical trials evaluating Duravyu (formerly EYP-1901), an investigational sustained-delivery intravitreal therapy, for diabetic macular edema (DME). The studies, known as COMO and CAPRI, are designed to assess the safety and efficacy of a 6-month dosing regimen compared with on-label aflibercept (Eylea; Regeneron).

Duravyu delivers vorolanib, a selective tyrosine kinase inhibitor, via a bioerodible intravitreal insert. Unlike anti-VEGF biologics that target extracellular ligands, vorolanib acts intracellularly to inhibit VEGF receptors and platelet-derived growth factor receptors, while also suppressing inflammation mediated by interleukin-6 signaling.

Each randomized, double-masked trial is expected to enroll approximately 240 patients, including both treatment-naïve and previously treated individuals, the company reported at the 49th meeting of the Macula Society. Participants are assigned to receive either Duravyu 2.7 mg every 6 months or standard aflibercept injections. The primary endpoint is noninferiority in change from baseline best-corrected visual acuity at weeks 52 and 56. Secondary measures include treatment burden, supplemental injection use, safety, and optical coherence tomography outcomes.

The phase 3 program follows a positive end-of-phase 2 meeting with the US Food and Drug Administration (FDA) and alignment with the European Medicines Agency. Topline data from the DME trials are expected in the second half of 2027.

The vorolanib intravitreal insert is also being evaluated as a potential treatment for neovascular age-related macular degeneration (nAMD) in a pair of pivotal phase 3 trials, LUGANO and LUCIA, that have enrolled more than 900 patients.