Sandoz, a Novartis division, announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept. Sandoz will begin enrolling the first patient in MYLIGHT, a clinical Phase III confirmatory efficacy and safety study, shortly.
Aflibercept binds and inhibits ocular VEGF-A, and prevents abnormal growth of blood vessels in the choroid which impact visual function. It improves visual acuity in patients with neovascular retinal diseases like nAMD, Diabetic macular edema (DME), and Retinal vein occlusion (RVO).
MYLIGHT is part of a comprehensive biosimilar development program including analytical, preclinical and clinical data. The study aims to confirm that the proposed biosimilar has equivalent efficacy and comparable safety to the reference medicine in patients with nAMD.
Sandoz has a leading global portfolio with eight marketed biosimilars and a further 15-plus in various stages of development. The Sandoz biosimilar pipeline is a blend of in-house development and collaborations, both for co-development and commercialization, targeting key biologics in oncology, immunology, endocrinology and underserved complex disease areas.