Abstract
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Introduction: Retinopathy of Prematurity (ROP) is a leading cause of preventable childhood blindness, with increasing use of Anti-Vascular Endothelial Growth Factor (anti-VEGF) therapy. However, the high cost of originator biologics limits access in resource-constrained settings, prompting interest in biosimilars as more affordable alternatives.
Methods: A systematic review was conducted following PRISMA guidelines to evaluate the safety and efficacy of intravitreal anti-VEGF biosimilars in preterm infants with ROP. Multiple databases were searched, and eligible studies reporting safety and/or efficacy outcomes were included. Data extraction and risk of bias assessment were performed independently, with treatment success, retreatment rates, and adverse events analysed using a random-effects model where appropriate.
Results: Five retrospective studies involving 382 eyes were included. The overall adverse event rate was 0.5%, with no reported systemic complications. Pooled treatment success was 65% for bevacizumab biosimilars and 46% for ranibizumab biosimilars. Approximately 1% of eyes required surgical intervention, and retreatment rates were high across both groups, reflecting variability in disease severity and treatment response.
Discussion/Conclusion: These findings suggest that biosimilars demonstrate favourable short-term safety but variable efficacy compared to originator anti-VEGF agents. Limitations include small sample sizes, heterogeneity in study design, and lack of long-term outcome data.
Anti-VEGF biosimilars represent a promising, cost-effective strategy to improve access to ROP treatment, particularly in low- and middle-income countries. Further randomised controlled trials are needed to establish comparative effectiveness and inform clinical practice.
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