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 eight 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. The primary endpoint will be changes in best-corrected visual acuity (BCVA) at weeks 52 and 56, with secondary measures including safety and the need for supplemental injections.
Duravyu is also being investigated in the VERONA phase 2 trial (NCT06099184) for diabetic macular edema (DME), with topline results anticipated in early 2025.