EFFECTIVENESS AND SAFETY OF BIOSIMILAR ANTIVASCULAR ENDOTHELIAL GROWTH FACTOR FOR RETINAL DISEASES: A Systematic Review and Meta-Analysis.

PURPOSE: To evaluate the comparative effectiveness and safety of biosimilar antivascular endothelial growth factor (VEGF) versus reference anti-VEGF intravitreal injections for the treatment of retinal diseases.

METHODS

A systematic review and meta-analysis was performed on studies identified through searches of Ovid MEDLINE, Embase, and the Cochrane Library between January 2015 and September 2024. Studies evaluating effectiveness and/or safety outcomes of biosimilar anti-VEGF were included. Meta-analysis was performed with a random-effects model. Risk of bias assessment was performed with the Joanna Briggs Institute tools, and certainty of evidence was evaluated with the Grading of Recommendations, Assessment, Development, and Evaluation criteria.

RESULTS

A total of 25 studies were included in the meta-analysis. Diagnoses studied were neovascular age-related macular degeneration, diabetic macular edema, retinal vein occlusion, and polypoidal choroidal vasculopathy. There were no significant differences in final visual acuity, change in visual acuity, final retinal thickness, change in retinal thickness, and incidence of adverse events over a follow-up duration of 12 to 63.6 weeks. Subgroup analyses of randomized controlled trials, observational studies, age-related macular degeneration, diabetic macular edema, and agent-specific analysis (aflibercept and ranibizumab) were not significant. Findings are supported by evidence of moderate to high certainty as per the Grading of Recommendations, Assessment, Development, and Evaluation tool. There was a low to moderate risk of bias in the included study as per the Joanna Briggs Institute tools.

CONCLUSION

Biosimilar anti-VEGF is comparable with reference anti-VEGF regarding safety profile and visual outcomes. Future research should prioritize including diverse patient populations and adopting standardized, extended follow-up periods to enhance the assessment of long-term safety and effectiveness of biosimilars.