Real-world outcomes of ranibizumab biosimilars in various retinal diseases: a Korean multi-center experience-ROSE Korea Study

Abstract

This study aims to investigate efficacy and safety of ranibizumab biosimilars (Amelivu (R) and LucenBS (R)) across retinal diseases in Korean clinical practice. This retrospective, multicenter study enrolled 1153 eyes from 1075 patients across five centers in South Korea between May 2022 and October 2024. Patients received intravitreal ranibizumab biosimilars for neovascular age-related macular degeneration, retinal vein occlusion with macular edema, diabetic macular edema, and other retinal diseases. Treatment-na & iuml;ve eyes comprised 408 cases (35.4%), while 745 eyes (64.6%) had prior anti-VEGF treatment. Amelivu was administered to 1007 eyes with 3.1 +/- 1.9 injections over 10.2 +/- 6.1 months; LucenBS to 146 eyes with 3.1 +/- 2.0 injections over 12.0 +/- 4.9 months. Amelivu demonstrated significant BCVA(logMAR) improvements from baseline (0.63 +/- 0.62) to 12 months (0.55 +/- 0.61, P < 0.01). LucenBS maintained logMAR VA from 0.64 +/- 0.63 to 0.63 +/- 0.68 at 12 months (P = 0.40). Both biosimilars achieved significant CMT reductions through 12 months: Amelivu from 398.0 +/- 169.4 mu m to 323.0 +/- 128.8 mu m (P < 0.01); LucenBS from 368.7 +/- 172.0 mu m to 306.0 +/- 144.1 mu m (P < 0.01). Treatment-na & iuml;ve eyes showed superior CMT reduction (111.8 mu m) compared to previously treated eyes (53.5 mu m). Only one injection-related adverse event occurred: asymptomatic anterior chamber cells in the Amelivu group, resolving with topical treatment. Ranibizumab biosimilars demonstrated visual stabilization and significant anatomical improvements across retinal diseases with excellent safety profiles.