
A Phase III, double-blind, multicenter trial compared the efficacy, safety, and immunogenicity of OPTIMAB® (Alkem Laboratories Ltd./Enzene Biosciences Ltd.), a biosimilar ranibizumab, with Innovator Ranibizumab in treatment-naive patients with neovascular age-related macular degeneration (nAMD). Among 152 patients, 141 (92.8%) completed the 12-week study. Both groups showed equivalent results, with 100% of patients maintaining a loss of < 15 letters in best-corrected visual acuity (BCVA) at week 12. Mean BCVA improvement was similar (OPTIMAB®: 11.8, Innovator Ranibizumab: 12.9; P = 0.5509), as were reductions in central subfoveal thickness (OPTIMAB®: −76.6 μm, Innovator Ranibizumab: −73.1 μm; P = 0.8422). Safety profiles and immunogenicity were comparable, with no patients developing anti-ranibizumab antibodies.
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