Study Indicates Bevacizumab Biosimilar Safe and Effective For Retinal Neovascular Conditions

Published: August 18, 2021

A 2017 study at various eye care centers in India was conducted to evaluate the efficacy and safety profile of intravitreal injection of a bevacizumab biosimilar for different retinal neovascular conditions. The biosimilar injections, 108 in total, were administered for Wet Age-Related Macular Degeneration, Diabetic Macular Edema, and Rental Vein Occlusion.(1)

While there are FDA-approved anti-VEGF drugs for the treatment of retinal diseases, bevacizumab is the most commonly used anti-VEGF drug used worldwide in the treatment of these conditions.(1) Bevacizumab is often used off-label for the treatment of diseases affecting the eye. Multiple studies have been conducted investigating the safety of the biosimilar for the on-label use of bevacizumab. For example, a 2019 study including 719 patients with non-small cell lung cancer, randomized to receive bevacizumab or its biosimilar found “no clinically meaningful differences in safety, pharmacokinetics, or immunogenicity across treatment groups.” Safety profiles were comparable.(2)

The study at the eye care centers in India was an analysis of patients who had undergone intravitreal therapy from August to November 2017, using the bevacizumab biosimilar, Zybev. Of the 108 eyes, 47 had Diabetic Macular Edema, 32 had Wet Age-Related Macular Degeneration, and 29 had Macular Edema secondary to Retinal Vein Occlusion.(1)

The study concluded that the intravitreal injection of the bevacizumab biosimilar “was well tolerated over a period of one month with improvement in Best Corrected Visual Acuity (BCVA) and Central Macular Thickness (CMA).”(1) In the discussion of the study, researchers state that more prospective, randomized studies with repeat injections and larger sample sizes are warranted to evaluate the long-term efficacy and safety of the biosimilar.(1)

The study concluded: “This short-term retrospective analysis suggests this biosimilar can be effective and safe in the management of various retinal neovascular conditions as well.”(1)

 


 

(1) Warudkar, S. M.D., International Journal of Advanced Research, Retrospective Efficacy and Safety Analysis of Zybev (Biosimilar of Bevacizumab) Use at Tertiary Eye care Centres in India: Spectra Study. https://www.journalijar.com/uploads/326_IJAR-21527.pdf
(2) Reinmuth, N., Bryl, M., et. al., National Library of Medicine, PF-06439335 (a Bevacizumab Biosimilar) Compared with Reference Bevacizumab (Avastin®), Both Plus Paclitaxel and Carboplatin, as First-Line Treatment for Advanced Non-Squamous Non-Small-Cell Lung Cancer: A randomized, Double-Blind Study, https://pubmed.ncbi.nlm.nih.gov/31338773/