Chakraborty Somnath, Sheth Jay Umed
Department of Vitreoretinal Services, Retina Institute of Bengal, Siliguri, India.
Department of Vitreoretinal Services, Shantilal Shanghvi Eye Institute, Mumbai, MH, India.
Clin Ophthalmol. 2024 Jan 6;18:61-68. doi: 10.2147/OPTH.S443104. eCollection 2024.
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.
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.
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.
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.
评估一种印度贝伐单抗生物类似药（Bevatas）在24周内治疗1型早产儿视网膜病变（ROP）和侵袭性后部ROP（APROP）中的作用。
一项回顾性、单中心、干预性研究，涉及144只眼睛，其中1型ROP（100只眼）和APROP（44只眼）。所有眼睛均接受了单次0.625mg Bevatas注射，并因反应欠佳而建议进行额外的激光治疗。
研究人群的平均胎龄为28.94（±2.32）周，平均出生体重为1.2（±0.34）kg，男性略占优势（52.05%）。贝伐单抗单药治疗24周后，144只眼中有65.97%的ROP完全消退，添加激光光凝后，140只眼中有97.22%的眼睛消退。其余4只眼（均为APROP）发展为4期ROP，需要进行玻璃体手术。使用贝伐单抗生物类似药单药治疗后，1型ROP眼的ROP完全消退率显著高于APROP眼（87%对18.18%；<0.00001）。所有1型ROP眼以及90.91%的APROP眼在接受额外的激光治疗后消退。研究人群未出现眼部或全身不良反应。
BIOS-ROP研究表明，玻璃体内注射贝伐单抗生物类似药单药治疗对1型ROP有显著益处，但对APROP无显著益处。低成本生物类似药有助于在医疗支出不断攀升的中低收入国家（LMICs）维持医疗保健系统。它们还可以通过使贝伐单抗等挽救视力的疗法更具可负担性和可及性来改善医疗公平性。
