EyePoint Pharmaceuticals has completed enrollment for its phase 3 LUGANO trial evaluating the vorolanib intravitreal insert (Duravyu, formerly EYP-1901), a potential treatment for neovascular age-related macular degeneration (nAMD), the company reported this week. More than 400 patients have been randomized into the study within 7 months.

LUGANO is the first of 2 pivotal noninferiority trials in the Duravyu phase 3 program. All patients began treatment on the first day of enrollment, with a primary endpoint at 1 year. The company expects topline data in mid-2026. A second trial, LUCIA, is still enrolling and expected to complete enrollment by the third quarter of 2025.  

Duravyu is a sustained-release tyrosine kinase inhibitor delivered through an intravitreal injection every 6 months. The treatment is designed to reduce the burden of frequent dosing, a challenge associated with existing anti-VEGF therapies. The LUGANO and LUCIA trials compare DURAVYU to aflibercept, with endpoints focused on visual acuity, safety, and treatment burden. EyePoint developed the program in alignment with the FDA following positive results from earlier trials.

The vorolanib intravitreal insert is also being evaluated as a potential treatment for diabetic macular edema (in the phase 2 VERONA trial) and for nonproliferative diabetic retinopathy (in the phase 2 PAVIA trial). RP