EyePoint Pharmaceuticals 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), the company said in a press release. Duravyu uses EyePoint's bioerodible Durasert E technology to deliver vorolanib, a selective tyrosine kinase inhibitor, via intravitreal injection every 6 months.

According to the company, 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. 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, the company said in the press release. 

Duravyu is also being investigated in the VERONA Phase 2 trial (NCT06099184) for diabetic macular edema, 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 as measured by optical coherence tomography, reflecting positive anatomical changes, the company said.