EyePoint Pharmaceuticals has released positive interim data from its phase 2 VERONA clinical trial (NCT06099184) evaluating Duravyu (EYP-1901) as a sustained-release treatment for diabetic macular edema (DME). After 16 weeks, Duravyu 2.7 mg showed an early and sustained improvement in best-corrected visual acuity (BCVA) and central subfield thickness (CST) compared to aflibercept 2 mg. Patients in the Duravyu arm gained +8.9 EDTRS letters, compared to +3.2 letters in the control, and demonstrated a 68 µm reduction in CST compared to a 30.5 µm reduction with aflibercept.
Duravyu is a sustained-release therapy that uses the company’s bioerodible Durasert E technology to deliver vorolanib, a selective tyrosine kinase inhibitor, via intravitreal injection.
VERONA’s primary endpoint measures the time to first supplemental aflibercept injection over 24 weeks. So far, 82% of patients in the Duravyu 2.7 mg group have remained supplement-free at 16 weeks, compared to 50% in the control group. EyePoint anticipates topline results from VERONA in the first quarter of 2025.
Duravyu is also being investigated in the phase 3 LUGANO (NCT06668064) and LUCIA (NCT06683742) trials for neovascular (“wet”) age-related macular degeneration (nAMD), after showing promising results in the DAVIO and DAVIO 2 trials, where the bioerodable insert demonstrated stable visual acuity and an 88% reduction in treatment burden over eight months.