Retrospective efficacy and safety analysis of zybev (biosimilar of bevacizumab) use at tertiary eye care centres in India: Spectra study

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Sandesh Warudkar

Cadila Healthcare Ltd, India

: J Nephrol Ren Dis

Abstract

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Purpose: The purpose of this study was to evaluate the efficacy and safety profile of intravitreal injection of bevacizumab biosimilar (Zybev) for various retinal neovascular conditions. Methods: Retrospective analysis was carried out on 108 injections which were administered with intravitreal Zybev injection at different tertiary eye care centers in India. The injections were administered for various indications such as wet age‑related macular degeneration (AMD), diabetic macular edema (DME), and retinal vein occlusion (RVO). Results: The mean age of the patients was 62.7 ± 8.40 years. A total of 61.1% injections were administered to men and 39.9% to women. The indications for which the injection was administered were DME (43.6%), wet AMD (28.7 %), and RVO (27.7%). Mean pretreatment BCVA was 0.94 ± 0.29 logMAR with CMT 355.76 ± 54.9 μm and post injection BCVA at day 30 was 0.81 ± 0.26 logMAR with CMT reducing to 292.20 ± 40.81 μm, indicating statistical significance (P = 0.001 and P < 0.0001, respectively) for all groups. Among the ocular side effects, none of the patients were reported with severe inflammation, endophthalmitis or rise in intraocular pressure (IOP) >21 mm of Hg during follow up period of one month post injection. No systemic adverse events were noted in study population. Conclusion: This retrospective analysis provides real world evidence regarding the efficacy and safety profile of biosimilar of bevacizumab, Zybev. However, more long term, prospective safety and efficacy studies are still awaited, this short term retrospective data suggest that Zybev can be effective and safe in the management of ocular conditions including DME, wet AMD and RVO.

Biography

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E-mail: sandx.pharma@gmail.com