EyePoint Pharmaceuticals reports that its investigational drug Duravyu met primary and secondary endpoints in a phase 2 trial for diabetic macular edema (DME). Duravyu uses the company’s bioerodible Durasert E technology to deliver vorolanib, a selective tyrosine kinase inhibitor, via intravitreal injection every 6 months.

The VERONA trial compared 2 doses of Duravyu (1.34 mg and 2.7 mg) to aflibercept 2 mg, measuring the time before patients required supplemental injections. Both Duravyu doses met the primary endpoint of extended time to first supplemental injection vs the aflibercept control, with the 2.7 mg dose delaying the need for additional treatment in 73% of patients. Patients receiving Duravyu also saw an average best-corrected visual acuity (BCVA) improvement of 7.1 ETDRS letters and a 75.9 µm reduction in central subfield thickness (CST) compared to baseline, according to the 6-month data. EyePoint reported no serious adverse events.

The company said it plans to meet with the US Food and Drug Administration later this year to discuss a potential phase 3 trial for DME. Duravyu is currently being studied as a treatment for neovascular (“wet”) age-related macular degeneration in a pair of phase 3 pivotal trials, LUCIA and LUGANO. The trials began enrolling patients in late 2024, and EyePoint said it expects topline data from these studies next year. RP