The Safety and Efficacy of Anti-Vascular Endothelial Growth Factor Biosimilars in Retinopathy of Prematurity.

AIM: Biosimilar anti-vascular endothelial growth factor agents are cheaper alternatives to current treatments, but their safety and efficacy are unknown. This review aims to evaluate the safety and efficacy of biosimilar anti-vascular endothelial growth factors in the management of retinopathy of prematurity.

METHODS

A systematic review of the current literature was undertaken to identify studies that reported safety and efficacy outcomes of intravitreal administration anti-vascular endothelial growth factor biosimilars in preterm infants with retinopathy of prematurity. Data were synthesised to assess safety, success and retreatment rates using random forest plots.

RESULTS

Five studies met the inclusion criteria (382 eyes); three studies used bevacizumab biosimilars (217 eyes) and two used ranibizumab biosimilars (118 eyes). The overall adverse event rate was 0.5%. The pooled treatment success rates were 65% (95% CI: 58%-71%) with bevacizumab biosimilars and 46% (95% CI: 2%-95%) with ranibizumab biosimilars. Five eyes (1%) in the whole cohort required surgery: four in the bevacizumab and one in the ranibizumab group.

CONCLUSIONS

Biosimilar anti-vascular endothelial growth factor agents demonstrated safety and reasonable efficacy. Biosimilars are a cost-effective alternative and may improve clinical outcomes in low-income countries. Randomised controlled trials should compare biosimilars to their reference biologic.

TRIAL REGISTRATION: PROSPERO: CRD420251010789.