Safety of Intravitreal Injection of Stivant, a Biosimilar to Bevacizumab, in Rabbit Eyes

Purpose: To evaluate the safety of intravitreal injection of Stivant, a biosimilar to bevacizumab, in rabbits using electrophysiological and histological analysis. Methods: Both eyes of 41 New Zealand albino rabbits were injected with 0.1 mL (2.5 mg) of Stivant. The rabbits were scheduled to b...

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Main Authors: Alireza Lashay, Hooshang Faghihi, Ahmad Mirshahi, Hassan Khojasteh, Alireza Khodabande, Hamid Riazi-Esfahani, Fahimeh Asadi Amoli, Elias Khalili Pour, Elham Delrish
Format: Article
Language:English
Published: Knowledge E 2020-08-01
Series:Journal of Ophthalmic & Vision Research
Subjects:
Online Access:https://doi.org/10.18502/jovr.v15i3.7453
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author Alireza Lashay
Hooshang Faghihi
Ahmad Mirshahi
Hassan Khojasteh
Alireza Khodabande
Hamid Riazi-Esfahani
Fahimeh Asadi Amoli
Elias Khalili Pour
Elham Delrish
author_facet Alireza Lashay
Hooshang Faghihi
Ahmad Mirshahi
Hassan Khojasteh
Alireza Khodabande
Hamid Riazi-Esfahani
Fahimeh Asadi Amoli
Elias Khalili Pour
Elham Delrish
author_sort Alireza Lashay
collection DOAJ
description Purpose: To evaluate the safety of intravitreal injection of Stivant, a biosimilar to bevacizumab, in rabbits using electrophysiological and histological analysis. Methods: Both 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. Results: No 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. Conclusion: The 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.
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spelling doaj.art-2fa3ceb81745447a8a27e787dccc9aae2022-12-22T02:43:26ZengKnowledge EJournal of Ophthalmic & Vision Research2008-322X2020-08-0115334135010.18502/jovr.v15i3.7453jovr.v15i3.7453Safety of Intravitreal Injection of Stivant, a Biosimilar to Bevacizumab, in Rabbit EyesAlireza Lashay0Hooshang Faghihi1Ahmad Mirshahi2Hassan Khojasteh3Alireza Khodabande4Hamid Riazi-Esfahani5Fahimeh Asadi Amoli6Elias Khalili Pour7Elham Delrish8 Translational Ophthalmology Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran Translational Ophthalmology Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran Translational Ophthalmology Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran Translational Ophthalmology Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran Translational Ophthalmology Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran Translational Ophthalmology Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran Translational Ophthalmology Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran Translational Ophthalmology Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran Translational Ophthalmology Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, IranPurpose: To evaluate the safety of intravitreal injection of Stivant, a biosimilar to bevacizumab, in rabbits using electrophysiological and histological analysis. Methods: Both 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. Results: No 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. Conclusion: The 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.https://doi.org/10.18502/jovr.v15i3.7453biosimilarintravitreal injectionsafetystivant
spellingShingle Alireza Lashay
Hooshang Faghihi
Ahmad Mirshahi
Hassan Khojasteh
Alireza Khodabande
Hamid Riazi-Esfahani
Fahimeh Asadi Amoli
Elias Khalili Pour
Elham Delrish
Safety of Intravitreal Injection of Stivant, a Biosimilar to Bevacizumab, in Rabbit Eyes
Journal of Ophthalmic & Vision Research
biosimilar
intravitreal injection
safety
stivant
title Safety of Intravitreal Injection of Stivant, a Biosimilar to Bevacizumab, in Rabbit Eyes
title_full Safety of Intravitreal Injection of Stivant, a Biosimilar to Bevacizumab, in Rabbit Eyes
title_fullStr Safety of Intravitreal Injection of Stivant, a Biosimilar to Bevacizumab, in Rabbit Eyes
title_full_unstemmed Safety of Intravitreal Injection of Stivant, a Biosimilar to Bevacizumab, in Rabbit Eyes
title_short Safety of Intravitreal Injection of Stivant, a Biosimilar to Bevacizumab, in Rabbit Eyes
title_sort safety of intravitreal injection of stivant a biosimilar to bevacizumab in rabbit eyes
topic biosimilar
intravitreal injection
safety
stivant
url https://doi.org/10.18502/jovr.v15i3.7453
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