Retrospective Efficacy and Safety Analysis of Zybev (Biosimilar of Bevacizumab) Use at Tertiary Eye Care Centres in India: Spectra Trial.

Warudkar., Sandesh

doi:10.21474/ijar01/6234

Cited by 3 publications

(2 citation statements)

References 3 publications

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“…[ 9 , 10 ] Warudkar et al . [ 11 ] showed the safety and efficacy of intravitreal injection of Zybev (Cadila Healthcare, India) as a bevacizumab bio-similar product for macular edema secondary to retinal vascular diseases. Mirshahi et al .…”

Section: Discussionmentioning

confidence: 99%

Efficacy and safety analysis of intravitreal bio-similar products of bevacizumab in patients with macular edema because of retinal diseases

Agarwal

Gupta

Agrawal

2023

Indian Journal of Ophthalmology

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Purpose: The purpose of this study was to evaluate retrospectively the efficacy and safety profile of intravitreal injection of bevacizumab bio-similar product Zybev(Z) for macular edema because of retinal diseases. Methods: A retrospective analysis was conducted on patients with macular edema because of retinal diseases, who had been administered intravitreal injections of bio-similar bevacizumab at a tertiary eye care center. Changes in the retinal thickness and visual acuity were evaluated to judge the efficacy, and adverse events were noted for the safety profile over a period of 6 weeks. Results: A total of 104 patients were included in the study. The mean age of the patients was 53 ± 13.5 years. The mean pre-injection best corrected visual acuity (BCVA) was 1.32 ± 0.70 log minimum angle of resolution (logMAR) with a central subfield thickness (CST) of 429.26 ± 204.30 μm, and the post-injection BCVA at 6 weeks was 1.13 ± 0.71 logMAR with a CST of 302.26 ± 104.50 μm; this change was statistically significant ( P < 0.05) for all groups. The mean average cube thickness (μm) decreased from 11.85 ± 1.96 pre-injection to 10.52 ± 1.75 post-injection, and the mean average cube volume (mm 3 ) decreased from 329.30 ± 54.35 to 302.23 ± 49.56 ( P < 0.05). During the follow-up period after injection, no patient had inflammation, endophthalmitis, an increase in intra-ocular pressure, or systemic side effects. Conclusion: This short-term retrospective analysis provides evidence regarding the efficacy and safety of intravitreal injection of bio-similar products of bevacizumab for the treatment of macular edema because of retinal diseases.

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Section: Discussionmentioning

confidence: 99%

Efficacy and safety analysis of intravitreal bio-similar products of bevacizumab in patients with macular edema because of retinal diseases

Agarwal

Gupta

Agrawal

2023

Indian Journal of Ophthalmology

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“…[13,14] Afterward, Warudkar et al showed the safety and efficacy of intravitreal injection of Zybev (Cadila Healthcare, India) as a bevacizumab biosimilar for macular edema secondary to retinal vascular diseases. [15] As the patent of Avastin has recently expired, it is speculated that its biosimilars will soon grow in number. [10,11] Biosimilar production is >25% cheaper than that of the reference drug.…”

Section: Discussionmentioning

confidence: 99%

Intraocular Injection of Stivant® (A Biosimilar to Bevacizumab): A Case Series

Mirshahi

Lashay

Riazi-Esfahani

et al. 2021

JOVR

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Purpose: To report the results of intravitreal injection of a bevacizumab biosimilar called Stivant®. Methods: This prospective interventional case series was conducted on eyes with neovascular age-related macular degeneration (nAMD), retinal vein occlusion (RVO), and diabetic macular edema (DME). Stivant® was injected in three consecutive months and changes in best-corrected visual acuity (BCVA) and central macular thickness (CMT) were measured at baseline and monthly up to one month after the third injection. Results: Three hundred and eighty-five eyes with DME (234 eyes, 61%), nAMD (87 eyes, 22%), and macular edema secondary to RVO (64 eyes, 17%) were enrolled. The mean ± standard deviation age of the patients was 61.7 ± 7.20 years. The mean BCVA and CMT changed from 0.63 ± 0.3 to 0.51 ± 0.3 LogMAR (P = 0.12 ) and from 420.4 ± 47.3μm at baseline to 316.7 ± 50.6 μm (P < 0.001) in the DME group; from 0.79 ± 0.3 to 0.68 ± 0.3 LogMAR (P = 0.19) and from 376.1 ± 31.7 μm to 303 ± 31.3 μm (P = 0.019) in the nAMD group; and from 0.81 ± 0.4 to 0.63 ± 0.4 LogMAR (P = 0.05) and from 424.21 ± 18 μm to 303.4 ± 18.8 μm (P < 0.001) in the RVO group, respectively. Conclusion: Our limited experience showed that the intravitreal injection of Stivant® was well tolerated. Although the results of this case series showed relative improvement in CMT one month after the last injection of Stivant®, BCVA improvement was statistically significant only in the RVO group. This would be essential to design a randomized clinical trial to evaluate the non-inferiority of Stivant® in comparison to bevacizumab.

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Initial Experience With Biosimilar Bevacizumab-bvzr For Intravitreal Use in Children: A Case Series and Literature Review

Jung¹,

Lee²,

Nagiel³

2023

Ophthalmic Surg Lasers Imaging Retina

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Background and Objective: We report our initial experience with intravitreal bevacizumab-bvzr, a bevacizumab biosimilar approved by the US Food and Drug Administration in 2019 and recently introduced by our institution for off-label ophthalmologic use in children. Patients and Methods: This was an Institutional Review Board-approved single-institution retrospective case series of pediatric patients 21 years or younger who received at least one intravitreal injection of biosimilar bevacizumab-bvzr. Results: Twelve eyes of 9 patients were identified as having received intravitreal bevacizumab-bvzr, with a total of 13 injections performed. Indications for injection included retinopathy of prematurity (7/13), choroidal neovascularization (3/13), retinal vein occlusion (2/13), and Coats disease (1/13). Following injection of bevacizumab-bvzr, all patients experienced a positive clinical response. No occurrences of postinjection inflammation, intraocular pressure anomalies, or endophthalmitis were observed with a median follow-up of 18 weeks. Conclusion: In the absence of controlled studies, this case series supports the use of intravitreal bevacizumab-bvzr as an anti-vascular endothelial growth factor therapy option, including in the pediatric population and resource-poor settings. [ Ophthalmic Surg Lasers Imaging Retina 2023;54:84–88.]

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Retrospective Efficacy and Safety Analysis of Zybev (Biosimilar of Bevacizumab) Use at Tertiary Eye Care Centres in India: Spectra Trial.

Cited by 3 publications

References 3 publications

Efficacy and safety analysis of intravitreal bio-similar products of bevacizumab in patients with macular edema because of retinal diseases

Efficacy and safety analysis of intravitreal bio-similar products of bevacizumab in patients with macular edema because of retinal diseases

Intraocular Injection of Stivant® (A Biosimilar to Bevacizumab): A Case Series

Initial Experience With Biosimilar Bevacizumab-bvzr For Intravitreal Use in Children: A Case Series and Literature Review

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