Sandoz to begin Phase III trial of aflibercept biosimilar

On May 3, 2021, Sandoz announced that it will begin enrolling patients in MYLIGHT, a clinical Phase III confirmatory efficacy and safety study for its proposed biosimilar to Regeneron’s EYLEA (aflibercept) product.  EYLEA is indicated for neovascular age-related macular degeneration (nAMD), diabetic macular oedema, macular oedema secondary to retinal vein occlusion, and other neovascular retinal diseases.

MYLIGHT is a randomized, double-blind, parallel 2-arm trial with a projected enrollment of 460 patients with nAMD in 20 countries.  Patients with nAMD will be randomized to receive either the biosimilar candidate or EYLEA for 48 weeks.  The mean change in best corrected visual acuity score from baseline to week 8 will serve as the primary end point.  The study aims to confirm that the biosimilar candidate has equivalent efficacy and comparable safety to EYLEA in patients with nAMD.