EyePoint Pharmaceuticals said an independent data safety monitoring committee has recommended that its phase 3 LUGANO and LUCIA trials of the vorolanib intravitreal insert (Duravyu, formerly EYP-1901) for neovascular (“wet”) age-related macular degeneration (nAMD) continue without changes. The review, completed after all participants in the 2 trials reached their initial dosing visit, found no safety concerns that warranted adjustments.

LUGANO and LUCIA have enrolled more than 900 patients and are comparing Duravyu, a sustained-release tyrosine kinase inhibitor delivered through an intravitreal injection every 6 months, with standard of care aflibercept 2 mg (Eylea; Regeneron). Both trials are designed to establish noninferiority in visual acuity outcomes at weeks 52 and 56, with secondary measures including treatment burden and anatomical results on optical coherence tomography. About one-quarter of patients receiving the study drug have reached the planned redosing visit at week 32. The committee, which meets every 6 months, evaluates unmasked safety data but does not assess efficacy.

EyePoint said the latest recommendation reinforces its confidence in the treatment’s safety profile. Ramiro Ribeiro, MD, PhD, the company’s chief medical officer, said the program remains on track to report topline data in mid-2026.

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