Real-Life Clinical Effectiveness of Razumab® (World’s First Biosimilar Ranibizumab) in Wet Age- Related Macular Degeneration, Diabetic Macular Edema, and Retinal Vein Occlusion: A Retrospective Pooled Analysis

Abstract

Purpose: To evaluate the effectiveness of Razumab^® (world's first biosimilar ranibizumab; Intas Pharmaceuticals Ltd., India) in Indian patients with wet age-related macular degeneration (wet AMD), diabetic macular edema (DME) and retinal vein occlusion (RVO). Methods: RE-ENACT, a retrospective, multicenter study, analyzed pooled data of patients with wet AMD, DME, and RVO. Patients who had received ≥3 injections of Razumab^® between January and August 2016, were included. Endpoints were: improvement in best corrected visual acuity (BCVA, measured by logMAR/Snellen's chart), decrease in central macular thickness (CMT, measured by Spectral Domain Optical Coherence Tomography), and proportion of patients with intraretinal fluid (IRF) and subretinal fluid (SRF) at Weeks 4, 8 and 12. Results: Of 561 patients included, 348 (62.04%) were men. Mean ± SE BCVA improved from baseline (0.75 ± 0.01) to Week 4 (0.72 ± 0.01, p = 0.0318), attained significance at Week 8 (0.59 ± 0.01, p ＜ 0.0001), which was maintained at Week 12 (0.49 ± 0.01, p ＜ 0.0001). Mean ± SE CMT significantly (p ＜ 0.0001) decreased from baseline (418.47 ± 4.78μm) to Weeks 4 (407.35 ± 4.65μm), 8 (342.10 ± 3.66μm), and 12 (301.17 ± 2.82μm). Proportion of patients with IRF and SRF significantly (p ＜ 0.0001) decreased from baseline to Weeks 4, 8 and 12 (67.02% vs. 48.48%, 42.60%, and 34.22%, respectively for IRF; and 72.37% vs. 48.48%, 37.97%, 31.37%, respectively for SRF). No new safety concerns with biosimilar ranibizumab were observed. Conclusions: Razumab^® is effective in reducing macular thickness and improving visual acuity in patients with wet agerelated macular degeneration, diabetic macular edema, and retinal vein occlusion in routine clinical practice. Razumab^® demonstrated considerable effectiveness with no new safety concerns.