Abstract
Purpose To evaluate the safety of intravitreal injection of Stivant, a biosimilar to bevacizumab, in rabbits using electrophysiological and histological analysis.MethodsBoth eyes of 41 New Zealand albino rabbits were injected with 0.1 mL (2.5 mg) of Stivant. The rabbits were scheduled to be sacrificed 1, 2, 7, 14, and 28 days after injection for histopathological evaluations. Clinical examinations and electroretinography (ERG) were performed at baseline and just before sacrificing the rabbits. Fourteen separate rabbits received a reference drug (Avastin) and were considered as the control group. Furthermore, three other rabbits received the same volume of saline (saline control group). Rabbits of both control groups were sacrificed four weeks after injection. ERG was performed 1, 2, 7, 14, and 28 days after injections.ResultsNo significant difference was observed in a- and b-wave amplitudes and latency after intravitreal Stivant injection between baseline and different time points. Moreover, there was no statistically significant difference in wave amplitudes and latency between the Stivant and control groups. The histology of rabbit eyes of the Stivant and control groups after intravitreal injections was not distinguishable.ConclusionThe biosimilar Stivant, up to a dose of 2.5 mg, did not appear to be toxic to the retina in albino rabbits. These results suggest that this drug could be a safe and inexpensive alternative to intravitreal bevacizumab. The efficacy of these injections was not investigated in this study and needs to be evaluated in future studies.
Highlights
Our results showed that a single intravitreal injection of the biosimilar to bevacizumab (Stivant) at doses up to 2.5 mg in albino rabbit eyes did not result in apparent vitreoretinal toxicity at 1, 2, 7, 14, and 28 days after injection, based on electrophysiological and histopathological findings
The ERG responses of the experimental and two control group eyes were similar in a- or b-wave amplitudes and implicit times at different time points after injections
Anti-Vascular endothelial growth factor (VEGF) agents play a key role in the management of different retinal conditions, such as wet age-related macular degeneration (AMD), diabetic macular edema, and retinal vein occlusion.[10,11,12]
Summary
Vascular endothelial growth factor (VEGF) plays a substantial role in angiogenesis and. A Bevacizumab Biosimilar; Lashay et al vasculogenesis It is the main target for the treatment of cancers and ophthalmic vascular disorders.[1, 2] The inhibition of VEGF causes regression of aberrant new vessels in experimental models of proliferative vascular retinopathies and neovascularization of the choroid.[3]
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