Objective: This study evaluated the efficacy and safety of the biosimilar Rimmyrah versus the reference ranibizumab in patients with diabetic macular edema (DME). Methods: This retrospective study included 70 patients with DME. They were divided into two groups: 35 patients (35 eyes) received the reference ranibizumab, and 35 patients (35 eyes) received the biosimilar ranibizumab. All patients were treated following a 3+ pro re nata (PRN) regimen. Best-corrected visual acuity (BCVA) and central retinal thickness (CRT) were compared between the groups at 3, 6, and 12 months post-treatment. Additionally, the foveal avascular zone (FAZ) area and macular vessel density were compared at baseline and 12 months, along with the total number of intravitreal injections required. Results: There were no statistically significant differences between the two groups in BCVA or CRT at any time point (all P > 0.05). Consistent with the therapeutic effect of ranibizumab, both groups showed significant improvements from baseline in BCVA and CRT (all P < 0.05). Similarly, no intergroup differences were found in FAZ area, superficial vascular density (SVD), or deep vascular density (DVD) at baseline or 12 months (all P > 0.05), with both groups exhibiting significant within-group improvements post-treatment (reduced FAZ, increased SVD and DVD; all P < 0.05). No statistically significant difference was observed in the mean number of intravitreal injections between the reference ranibizumab group (3.43 ± 0.65) and its biosimilar group (3.69 ± 0.76) during the study period (P = 0.1530). No treatmentrelated serious ocular or systemic adverse events occurred in either group during the 12-month follow-up. Conclusion: The ranibizumab biosimilar (Rimmyrah) showed similar safety and efficacy profiles to its reference product in the treatment of diabetic macular edema.
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