Safety of an Intravitreal Bevacizumab Biosimilar (MVASI).

Background: Intravitreal bevacizumab has been used off-label to treat multiple ocular conditions for almost two decades. Reference bevacizumab, Avastin, was discontinued in Australia in 2021. A bevacizumab biosimilar, MVASI, was approved by the Therapeutic Goods Administration for the treatment of metastatic cancer in 2020. There is limited safety data for the off-label intravitreal use of MVASI. This retrospective study evaluates the safety of intravitreal MVASI.

Methods: Retrospective review of all eyes that were given intravitreal MVASI at all metropolitan public hospitals in South Australia between 1st May 2022 and 30th May 2024. Demographic data, injection indications, number of injections per eye, whether patients were switched to another agent, and associated complications were collected from electronic and paper medical records.

Results: A total of 6230 injections were given to 1682 eyes in this study. The mean age of the study population was 69.8 ± 15.6 years. The overall mean number of MVASI injections given per eye was 3.7 ± 2.9 (range 1-21). The indications for treatment were neovascular age-related macular degeneration (2106 injections; 33.8%), diabetic macular oedema (1634 injections; 26.2%), branch retinal vein occlusion (695 injections; 11.2%), proliferative diabetic retinopathy (596 injections; 9.6%), central retinal vein occlusion (558 injections; 9.0%) and other (641 injections; 10.3%). Significant sight-threatening complications included 3 cases of bacterial endophthalmitis (0.05%) and 3 cases of uveitis (0.05%). No cases of retinal vasculitis were observed.

Conclusions: Intravitreal MVASI had a similar ophthalmic safety profile and may be used as an alternative to Avastin.