Efficacy and Safety of Aflibercept Biosimilars Relative to Reference Aflibercept Therapy for Neovascular Age-Related Macular Degeneration: A Systematic Review and Meta-Analysis

Abstract

Purpose: To assess the efficacy and safety of aflibercept biosimilars compared to reference aflibercept therapy for neovascular age-related macular degeneration (nAMD) through a systematic review and meta-analysis. Methods: A comprehensive literature search was conducted across multiple databases. Randomized controlled trials comparing intravitreal aflibercept biosimilars with reference aflibercept in patients with nAMD were included. The outcomes were changes in best-corrected visual acuity (BCVA), retinal thickness, choroidal neovascularization (CNV) leakage area from baseline based on fluorescein angiography, and adverse events. Results: Five studies involving 2,039 patients were included. No statistically significant differences were found between aflibercept biosimilars and reference aflibercept in terms of BCVA (weighted mean difference [WMD]: 1.05; 95% CI: −0.62 to 2.71; p = 0.22), central subfield thickness (WMD: 3.33; 95% CI: −14.48 to 21.14; p = 0.71), or CNV (WMD: −0.23; 95% CI: −0.58 to 0.12; p = 0.20). SThe incidence of treatment-emergent adverse events was similar between groups. Conclusion: Aflibercept biosimilars demonstrated comparable efficacy and safety profiles to reference aflibercept in the treatment of nAMD. These findings suggest that biosimilars may serve as a cost-effective alternative without compromising patient outcomes.