Abstract
Purpose :
Neovascular diseases of the retina represent a significant disease burden with diabetic retinopathy being the leading cause of blindness in the western world. The development of anti-VEGF drugs revolutionized the treatment of these diseases and significantly improved outcomes. In recent studies, bevacizumab has been proven to be noninferior to Ranibizumab, making anti-VEGF more accessible to patients. New biosimilar molecules to bevacizumab have been approved for use in cancer patients but have yet to be approved in the eye. The goal of this study is to demonstrate that these molecules are safe and effective at reducing neovascularization in the eye.
Methods :
Mouse and rabbit models were used to investigate efficacy and safety, respectively, of two novel anti-VEGF biosimilars. Animals were randomized to receive either bevacizumab, Mvasi or Zirabev in one eye; contralateral eyes served as saline or no treatment controls. For the efficacy arm of the study, adult C57BL/6J mice received four laser burns per eye to induce choroidal neovascularization (CNV). Intravitreal anti-VEGF treatments were administered 4,10, and 14 days post-injury followed by fundus fluorescein angiography (FA) and OCT weekly. For the safety study, adult New Zealand White rabbits received a single intravitreal anti-VEGF treatment. Animals were followed weekly with both photopic and scotopic ERG in addition to OCT at endpoint.
Results :
CNV was observed in all groups indicated by fluorescein leakage at each laser-induced lesion. No difference was observed in the change of overall area or mean gray value between injury and endpoint among biosimilar treatments. Further, no difference was observed in the change of area and depth of lesions post biosimilar treatment. Regarding safety, no significant changes were seen in A or B wave amplitude over the 4 weeks across all groups. When compared with the contralateral eye controls (saline only), none of the eyes treated with anti-VEGF showed a decrease in amplitude in either photopic or scotopic ERG.
Conclusions :
To date, we have seen no difference in the efficacy of bevacizumab, Zirabev and Mvasi. Further, there have been no adverse structural changes and no changes in retinal function. We conclude that these drugs may be suitable alternatives to bevacizumab but will need to be further investigated through a clinical trial.
This abstract was presented at the 2022 ARVO Annual Meeting, held in Denver, CO, May 1-4, 2022, and virtually.