Efficacy and Safety of an Indian Bevacizumab BIOSimilar (BEVATAS) for Treatment-Naïve Diabetic Macular Edema (BIOS-DME Study)

Purpose: To evaluate the anatomical and functional efficacy of bevacizumab biosimilar (Bevatas ® ) in the treatment of diabetic macular edema (DME) in a real-world Indian clinical setting. Patients and Methods: This retrospective observational study included 123 eyes of patients with center-involving DME (CI-DME) treated with intravitreal biosimilar of bevacizumab (IVBb) between January 2022 and December 2025. Eyes received three loading doses followed by pro-re-nata regimen with supplemental focal laser as needed. Best-corrected visual acuity (BCVA), central macular thickness (CMT), intraocular pressure, (IOP), and optical coherence tomography (OCT) biomarkers were assessed at baseline and at months 1, 2, 3, 6, and 12. Treatment burden and safety outcomes were recorded. Results: Mean visual acuity improved from 0.591 ± 0.276 logMAR at baseline to 0.249 ± 0.079 logMAR at month 12, representing a gain of 0.342 logMAR ( P < 0.001). Central macular thickness decreased from 469.9 ± 132.4 μm to 196.9 ± 51.8 μm ( P < 0.001). Hyperreflective foci (HRF), present in 35.8% of eyes at baseline, resolved completely by month 1 and remained absent throughout follow-up. Eyes received a mean of 4.6 ± 1.3 injections over 12 months. Supplemental focal laser was administered in 55.3% of eyes. IOP remained stable Anatomical response showed fluctuation at month 6, with partial recurrence of edema, followed by recovery at month 12. No significant ocular or systemic adverse events were noted. Conclusion: Bevacizumab biosimilar produces meaningful visual and anatomical improvement in CI-DME in a real-world Indian setting. The modest injection frequency reflects practical treatment patterns in resource-limited environments. IVBb represents an accessible and affordable anti-vascular endothelial growth factor (anti-VEGF) option for DME management in India and similar healthcare contexts.