Multicentre safety study on the use of bevacizumab biosimilar in treatment of type I retinopathy of prematurity

Abstract

Purpose: To report the initial experience with a bevacizumab biosimilar (MVASI) across Australian centres in the treatment of type I retinopathy of prematurity (ROP) Method: A one-year retrospective multicentre audit. Infants treated for type I ROP using intravitreal MVASI (bevacizumab-awwb) at the Royal Brisbane Women's Hospital, Mater Hospital Brisbane and Royal Children's Hospital Melbourne between August 2022 and August 2023 were included. Results: Eighty-three eyes of 42 children received MVASI as management of type I ROP. The mean gestational age and birth weight was 24.6 weeks and 659.3 g respectively. No eyes that received MVASI had any immunogenic reaction post injection. No medication related complications were detected over an average follow-up period of 68 weeks. Ten eyes had laser treatment prior to MVASI injection. Of the 73 eyes that received MVASI as initial therapy, 27 eyes (37%) required retreatment for reactivation. The average postmenstrual age at retreatment post primary MVASI therapy was 44.9 weeks with time to reactivation being 56.8 days. Modality for retreatment was primarily laser (18 eyes, 66.7%), followed by repeat intravitreal bevacizumab (seven eyes, 25.9%) with two eyes requiring combined therapy (2.7%). Conclusion: This is the first study of biosimilar drug safety and efficacy in the treatment of ROP. This multicentre case series supports the use of MVASI as a safe and equivalent alternative to Avastin for treatment of type I ROP in neonates. No ophthalmic complications were recorded during the study period.