Efficacy of an Indian Bevacizumab BIOSimilar (BEVATAS) for Type 1 and Aggressive Posterior Retinopathy of Prematurity (BIOS-ROP Study)
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 Instit...
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| Format: | Article |
| Language: | English |
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Dove Medical Press
2024-01-01
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| Series: | Clinical Ophthalmology |
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| Online Access: | https://www.dovepress.com/efficacy-of-an-indian-bevacizumab-biosimilar-bevatas-for-type-1-and-ag-peer-reviewed-fulltext-article-OPTH |
| _version_ | 1797362690461532160 |
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| author | Chakraborty S Sheth JU |
| author_facet | Chakraborty S Sheth JU |
| author_sort | Chakraborty S |
| collection | DOAJ |
| description | 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 somnathboom@gmail.comPurpose: 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 |
| first_indexed | 2024-03-08T16:10:07Z |
| format | Article |
| id | doaj.art-18aff928ad0d4107bf05fcea135a63b3 |
| institution | Directory Open Access Journal |
| issn | 1177-5483 |
| language | English |
| last_indexed | 2024-03-08T16:10:07Z |
| publishDate | 2024-01-01 |
| publisher | Dove Medical Press |
| record_format | Article |
| series | Clinical Ophthalmology |
| spelling | doaj.art-18aff928ad0d4107bf05fcea135a63b32024-01-07T18:06:43ZengDove Medical PressClinical Ophthalmology1177-54832024-01-01Volume 18616889549Efficacy of an Indian Bevacizumab BIOSimilar (BEVATAS) for Type 1 and Aggressive Posterior Retinopathy of Prematurity (BIOS-ROP Study)Chakraborty SSheth JUSomnath 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 somnathboom@gmail.comPurpose: 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, bevatashttps://www.dovepress.com/efficacy-of-an-indian-bevacizumab-biosimilar-bevatas-for-type-1-and-ag-peer-reviewed-fulltext-article-OPTHretinopathy of prematuritylaser photocoagulationbevacizumabbiosimilarbevatas |
| spellingShingle | Chakraborty S Sheth JU Efficacy of an Indian Bevacizumab BIOSimilar (BEVATAS) for Type 1 and Aggressive Posterior Retinopathy of Prematurity (BIOS-ROP Study) Clinical Ophthalmology retinopathy of prematurity laser photocoagulation bevacizumab biosimilar bevatas |
| title | Efficacy of an Indian Bevacizumab BIOSimilar (BEVATAS) for Type 1 and Aggressive Posterior Retinopathy of Prematurity (BIOS-ROP Study) |
| title_full | Efficacy of an Indian Bevacizumab BIOSimilar (BEVATAS) for Type 1 and Aggressive Posterior Retinopathy of Prematurity (BIOS-ROP Study) |
| title_fullStr | Efficacy of an Indian Bevacizumab BIOSimilar (BEVATAS) for Type 1 and Aggressive Posterior Retinopathy of Prematurity (BIOS-ROP Study) |
| title_full_unstemmed | Efficacy of an Indian Bevacizumab BIOSimilar (BEVATAS) for Type 1 and Aggressive Posterior Retinopathy of Prematurity (BIOS-ROP Study) |
| title_short | Efficacy of an Indian Bevacizumab BIOSimilar (BEVATAS) for Type 1 and Aggressive Posterior Retinopathy of Prematurity (BIOS-ROP Study) |
| title_sort | efficacy of an indian bevacizumab biosimilar bevatas for type 1 and aggressive posterior retinopathy of prematurity bios rop study |
| topic | retinopathy of prematurity laser photocoagulation bevacizumab biosimilar bevatas |
| url | https://www.dovepress.com/efficacy-of-an-indian-bevacizumab-biosimilar-bevatas-for-type-1-and-ag-peer-reviewed-fulltext-article-OPTH |
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