Sandoz, a division of Novartis, 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 3 confirmatory efficacy and safety study, shortly.1
Aflibercept (Eylea; Regeneron) is indicated to improve visual acuity in patients with wet age-related macular degeneration (AMD), diabetic macular edema, macular edema secondary to retinal vein occlusion, and other specific neovascular retinal diseases.3
“Neovascular AMD accounts for 10% of all age-related macular degeneration cases, but is responsible for 90% of AMD-related blindness,”2 Florian Bieber, Global Head of Biopharmaceuticals Development, Sandoz, said in a company news release. “Aflibercept is a key treatment in ophthalmology. The initiation of this study marks an important milestone in the development of our biosimilar aflibercept. As with all our biosimilar programs, we aim to expand access to high-quality, more affordable biologics.”
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.1
Sandoz biosimilars help patients to access advanced biologic medicines more sustainably and affordably, according to Sandoz. The Sandoz division has eight marketed biosimilars and a further 15-plus in various stages of development.
MYLIGHT is a randomized, double-blind, parallel 2-arm study, which is projected to include 460 patients across 20 countries. The MYLIGHT study will be conducted in neovascular (wet) age-related macular degeneration as this is an adequately sensitive indication and representative of many patients who are treated with the medicine.1 Wet AMD patients will be randomized to receive either biosimilar aflibercept or the reference medicine for 48 weeks. The primary endpoint is the mean change in best corrected visual acuity (BCVA) score from baseline to week 8, using a standard test chart (EDTRS).
The global development program for Sandoz’ biosimilar aflibercept was developed in consultation with major regulatory agencies and the results from this clinical study are expected to support regulatory submissions.