EyePoint Pharmaceuticals has dosed the first patients in its global Phase 3 LUCIA clinical trial (NCT06683742) for Duravyu (EYP-1901), a sustained-release therapy for neovascular (wet) age-related macular degeneration (nAMD). Duravyu uses the company’s bioerodible Durasert E technology to deliver vorolanib, a selective tyrosine kinase inhibitor, via intravitreal injection every 6 months.
LUCIA represents the second pivotal study in EyePoint’s Phase 3 program, alongside the ongoing LUGANO trial (NCT06668064), with topline data anticipated in 2026. Duravyu showed promising results in the DAVIO and DAVIO 2 trials, demonstrating stable visual acuity and a >85% reduction in treatment burden over 8 months. LUGANO and LUCIA are expected to enroll about 400 patients globally, with Duravyu dosed every 6 months, and will compare the therapy to aflibercept injections. According to the company, the primary endpoint will be changes in BCVA at weeks 52 and 56, with secondary measures including safety and the need for supplemental injections.
In addition, Duravyu is also being investigated in the VERONA Phase 2 trial (NCT06099184) for diabetic macular edema (DME), with topline results anticipated in early 2025.