Visual outcomes, safety profile and morphometric response of optical coherence tomography biomarkers to ranibizumab biosimilar treatment in neovascular age-related macular degeneration: Real-world evidence

Abstract

Purpose: The aim of this study was to evaluate the safety, efficacy, and morphological response of intravitreal ranibizumab biosimilar (Razumab) in neovascular age-related macular degeneration (n-AMD) up to 12 weeks. Methods: Retrospective analysis of 20 eyes of n-AMD receiving 4 weekly intravitreal Razumab. Main outcome measures were mean change in best-corrected visual acuity (BCVA), intraretinal-fluid (IRF), subretinal-fluid (SRF), central-subfield thickness (CSFT), maximum central-retinal thickness (CRT), and dimensions of pigment epithelial detachment (PED) from baseline to weeks 4, 8 and 12. Results: Improvement in BCVA was seen at all visits, although not significantly (4 weeks: P = 0.18; 8 weeks: P = 0.4; 12 weeks: P = 0. 06). At 12 weeks, 90% of eyes either maintained or had an improvement in BCVA, with 40% of them showing an improvement of ≥3-lines and only 5% of them losing ≥3-lines of visual acuity. The median PED height and PED width reduced by 20.5 µm (P = 0.03) and 557.5 µm (P = 0.14), respectively, along with a mean reduction of 57.26 µmin CSFT (P < 0.001) and 44.15 µm in CRT (P = 0.004), respectively, at 12 weeks. On qualitative analysis, resolution of SRF and IRF was observed in 45% and 25% of eyes ' at 12 weeks. There were no serious ocular or systemic side effects identified. Conclusion: In real-world scenario, Razumab is an efficacious and economical anti-vascular endothelial growth factor (anti-VEGF) agent for optimal management of n-AMD. The therapeutic outcomes demonstrated reasonable stabilization and improvement in visual acuity, favorable anatomical outcomes pertaining to OCT-biomarkers with an acceptable safety profile.

Keywords

• age-related macular degeneration
• anti-vegf
• biosimilars
• optical coherence tomography
• razumab