Efficacy of an Indian Bevacizumab BIOSimilar (BEVATAS) for Type 1 and Aggressive Posterior Retinopathy of Prematurity (BIOS-ROP Study)

Overview

Journal Clin Ophthalmol

Publisher Dove Medical Press

Specialty Ophthalmology

Date 2024 Jan 11

PMID 38205264

Authors

Somnath Chakraborty

Jay Umed Sheth

Affiliations

Soon will be listed here.

Abstract

Purpose: To evaluate the role of an Indian bevacizumab biosimilar (Bevatas), for the management of type 1 retinopathy of prematurity (ROP) and aggressive posterior ROP (APROP) over 24-weeks.

Patients And Methods: A retrospective, single-center, interventional study of 144 eyes of type 1 (100 eyes) and APROP (44 eyes). All eyes received a single dose of 0.625mg Bevatas injection, and were advised additional laser therapy for suboptimal response.

Results: The study population had a mean gestational age of 28.94 (±2.32) weeks, an average birth weight of 1.2 (±0.34) kg, and modest male predominance (52.05%). Complete regression of ROP was seen in 65.97% of 144 eyes after 24 weeks of bevacizumab monotherapy, and in 97.22% of eyes (140 eyes) after adding laser photocoagulation. The remaining four eyes (all had APROP) developed Stage 4 ROP and needed vitreous surgery. After monotherapy with bevacizumab biosimilar, type 1 ROP eyes had significantly higher rate of complete ROP regression than APROP eyes (87% vs 18.18%; <0.00001). All eyes with type 1 ROP, and 90.91% of eyes with APROP, regressed after receiving additional laser therapy. The study population experienced no ocular or systemic adverse effects.

Conclusion: The BIOS-ROP study demonstrates that intravitreal bevacizumab biosimilar monotherapy offers significant benefit for type 1 ROP, but not APROP. Low-cost biosimilars can help sustain healthcare systems in lower-middle income countries (LMICs) with escalating healthcare expenditures. They can also improve healthcare equity by making vision-saving therapies like bevacizumab more affordable and accessible.

Citing Articles

Comparing safety and efficacy of Bevacizumab, Ranibizumab and Ranibizumab biosimilar in Retinopathy of prematurity.

Maitra P, Jaju S, Agrawal K, Das A, Subramaniam P, Venkatapathy N Eye (Lond). 2025; .

PMID: 40016518 DOI: 10.1038/s41433-025-03735-z.

Efficacy and Safety of an Indian Bevacizumab BIOSimilar (BEVATAS) for Retinal Vein Occlusion (BIOS-RVO Study).

Chakraborty S, Sheth J Clin Ophthalmol. 2024; 18:2865-2871.

PMID: 39398466 PMC: 11471115. DOI: 10.2147/OPTH.S473329.

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