EyePoint Pharmaceuticals Inc., (NASDAQ: EYPT) has announced that its drug candidate Durvayu (vorolanib intravitreal insert; EYP-1901) did not meet its primary endpoints in the Phase II PAVIA clinical trial for non-proliferative diabetic retinopathy (NPDR). Although the trial data showed some treatment effect, including a reduction in NPDR progression rates at nine months and a favorable safety profile, the primary endpoint was not achieved. A comprehensive update will be provided once the 12-month data is reviewed.
The study involved 77 NPDR patients, with the primary efficacy endpoint set as an improvement of at least two diabetic retinopathy severity scale (DRSS) levels by week 36 (approximately nine months) post-first injection. In the Durvayu treatment groups, 86% in the 3mg arm and 80% in the 2mg arm showed stable or improved disease at nine months, compared to 70% in the control arm, which received a sham injection. However, only 5% of patients in the 3mg arm and 0% in the 2mg arm achieved a ≥2-step improvement in DRSS score at nine months, compared to 5% in the control arm.
Vorolanib, the active ingredient in Durvayu, is a dual tyrosine kinase inhibitor that targets vascular endothelial growth factor receptor (VEGFR) and platelet-derived growth factor receptor (PDGFR). It is designed to inhibit neovascularization and tumor growth while avoiding common toxic side-effects associated with similar targeted drugs. The rights for the development of vorolanib in Greater China are licensed to Betta Pharmaceuticals (SZ.300558) under a May 2022 deal. Betta secured market approval for vorolanib in combination with everolimus for the treatment of renal cell carcinoma in June 2023, with ongoing work to assess the drug in ophthalmic indications such as wet age-related macular degeneration (w-AMD) and choroidal neovascularization (mCNV).- Flcube.com
