A proposed biosimilar to reference ranibizumab met the primary outcome of similarity to ranibizumab for efficacy and safety in the treatment of patients with treatment-naive nAMD, according to a poster presented at AAO 2020 Virtual.
A total of 429 patients were randomized to receive the biosimilar FYB201 (n = 215) or ranibizumab (n = 214) every 4 weeks for 48 weeks. The mean change from baseline in best corrected visual acuity (BCVA) at 8 weeks was 5.2 and +6.0 EDTRS letters for patients treated with FYB201 and ranibizumab, respectively. At 48 weeks, similar efficacy was maintained with a mean change of +7.9 and +8.5 EDTRS letters, respectively.
Secondary efficacy endpoints, safety, immunogenicity, and pharmacokinetics were similar between the groups.
Holz FG, et al. COLUMBUS-AMD: Efficacy and Safety of FYB201, a Proposed Biosimilar to Ranibizumab, in nAMD. Presented at: AAO 2020 Virtual.