Alvotech announced positive top-line results from a confirmatory clinical study for AVT06, Alvotech's proposed biosimilar to Eylea (aflibercept). Eylea is a widely used biologic for the treatment of eye disorders, including diseases which can lead to vision loss or blindness, such as wet AMD, macular edema, and diabetic retinopathy. The AVT06-GL-C01 confirmatory clinical study is a randomized, double-masked, parallel-group, multicenter, therapeutic equivalence study evaluating the efficacy, safety, and immunogenicity of AVT06 compared with Eylea in patients with neovascular (wet) AMD.

The primary outcome measure was change from baseline to Week 8 in Best-Corrected Visual Acuity (BCVA). The study met its primary endpoint, with results demonstrating therapeutic equivalence between Alvotech?s biosimilar candidate and Eylea.