Chakraborty Somnath, Sheth Jay Umed
Department of Vitreoretinal Services, Retina Institute of Bengal, Siliguri, India.
Department of Vitreoretinal Services, Shantilal Shanghvi Eye Institute, Mumbai, Maharashtra, India.
Clin Ophthalmol. 2024 Oct 9;18:2865-2871. doi: 10.2147/OPTH.S473329. eCollection 2024.
To evaluate the efficacy and safety of Bevatas, an Indian bevacizumab biosimilar, in the management of both Central Retinal Vein Occlusion (CRVO) and Branch Retinal Vein Occlusion (BRVO) (BIOS-RVO).
The BIOS-RVO study was a retrospective interventional study conducted at a single tertiary eye care facility in India. 154 treatment-naïve eyes with RVO (CRVO: 62 eyes; BRVO: 92 eyes) received intravitreal bevacizumab biosimilar (IVBb) therapy. Data on best-corrected visual acuity (BCVA), central macular thickness (CMT), and intraocular pressure (IOP) were collected at baseline and at 3, 6, and 12 months post-therapy.
The average age of participants was approximately 55.99 (+12.56) years, with a nearly equal gender distribution (M:F = 49.4:50.6). Age differences between BRVO and CRVO groups were not significant (=0.501), but gender distribution varied significantly (=0.035), with more males in the CRVO group. Significant improvements in BCVA were observed in both CRVO and BRVO groups at 3 months, 6 months, and 1 year compared to baseline (<0.001). Both groups showed significant reductions in CMT throughout the follow-up period (<0.001). The mean number of injections was higher in the CRVO group (5.27[±1.45]) compared to the BRVO group (4.27 [±1.28]) (<0.001). Significant IOP increases were observed at 1 month (<0.001) and 6 months (<0.001) in both BRVO and CRVO groups, although not clinically significant. Safety analysis revealed no additional ocular or systemic adverse events during the study period.
The BIOS-RVO study demonstrates that Bevatas is an effective and safe treatment option for both CRVO and BRVO. These findings support the use of Bevatas as a cost-effective alternative to branded anti-VEGF agents, particularly in resource-limited settings.
评估印度贝伐单抗生物类似药Bevatas在治疗视网膜中央静脉阻塞（CRVO）和视网膜分支静脉阻塞（BRVO）（BIOS-RVO）中的疗效和安全性。
BIOS-RVO研究是在印度一家单一的三级眼科护理机构进行的一项回顾性干预研究。154只初治的RVO眼（CRVO：62只眼；BRVO：92只眼）接受了玻璃体内贝伐单抗生物类似药（IVBb）治疗。在基线以及治疗后3个月、6个月和12个月收集最佳矫正视力（BCVA）、中心黄斑厚度（CMT）和眼压（IOP）的数据。
参与者的平均年龄约为55.99（±12.56）岁，性别分布几乎相等（男：女 = 49.4：50.6）。BRVO组和CRVO组之间的年龄差异不显著（P = 0.501），但性别分布差异显著（P = 0.035），CRVO组男性更多。与基线相比，CRVO组和BRVO组在3个月、6个月和1年时的BCVA均有显著改善（P < 0.001）。在整个随访期间，两组的CMT均显著降低（P < 0.001）。CRVO组的平均注射次数（5.27[±1.45]）高于BRVO组（4.27 [±1.28]）（P < 0.001）。BRVO组和CRVO组在1个月（P < 0.001）和6个月（P < 0.001）时眼压均有显著升高，尽管在临床上无显著意义。安全性分析显示，在研究期间未发现额外的眼部或全身不良事件。
BIOS-RVO研究表明，Bevatas是治疗CRVO和BRVO的一种有效且安全的治疗选择。这些发现支持将Bevatas作为品牌抗VEGF药物的一种具有成本效益的替代药物，尤其是在资源有限的环境中。
