Clinical Ophthalmology (Jan 2024)

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

  • Chakraborty S,
  • Sheth JU

Journal volume & issue
Vol. Volume 18
pp. 61 – 68

Abstract

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Somnath Chakraborty,1 Jay Umed Sheth2 1Department of Vitreoretinal Services, Retina Institute of Bengal, Siliguri, India; 2Department of Vitreoretinal Services, Shantilal Shanghvi Eye Institute, Mumbai, MH, IndiaCorrespondence: Somnath Chakraborty, Department of Vitreoretinal Services, Retina Institute of Bengal, Siliguri, West Bengal, India, Email [email protected]: 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%; P< 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.Keywords: retinopathy of prematurity, laser photocoagulation, bevacizumab, biosimilar, bevatas

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