EyePoint Pharmaceuticals has dosed the first patients in its phase 3 LUGANO clinical trial 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.

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. The LUGANO (NCT06668064) and LUCIA (NCT06683742) trials 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. The company recently announced promising 16-week interim results from VERONA, which found that a 2.7 mg dose of Duravyu demonstrated a significant early improvement in BCVA, with a gain of +8.9 letters from baseline, compared to +3.2 in the aflibercept control arm. Additionally, Duravyu achieved a 68 µm reduction in central subfield thickness (CST) as measured by optical coherence tomography, reflecting positive anatomical changes.