Biosimilar Versus Innovator Ranibizumab in Myopic CNVM: Comparative Real-World Outcomes- The BRIM Study

To compare the efficacy and safety of biosimilar ranibizumab (Razumab^®) versus innovator ranibizumab (Lucentis^®/Accentrix^®) in the treatment of myopic choroidal neovascular membrane (mCNVM).

This retrospective, multicenter study included treatment-naïve patients with mCNVM between January 2021 and December 2023. Patients received intravitreal injections of either innovator or biosimilar ranibizumab, following a pro re nata (PRN) protocol. Inclusion criteria were: age ≥18years, axial length >26.5 mm or spherical equivalent ≥ -6.00 D, diagnosis confirmed by multimodal imaging, and a minimum 12-month follow-up. Outcomes assessed included change in best-corrected visual acuity (BCVA; ETDRS letters), central macular thickness (CMT), intraocular pressure (IOP), injection frequency, and safety profile.

A total of 80 eyes were analyzed (Group A: Innovator, n=38; Group B: Biosimilar, n=42). Mean BCVA improved from 51.0 ± 16.5 to 64.5 ± 5.5 ETDRS letters in the Innovator group and from 52.5 ± 16.5 to 64.5 ± 4.5 in the Biosimilar group at 12 months (p > 0.05). CMT reduced significantly in both groups (Innovator: from 332.03 ± 39.22 µm to 268.32 ± 18.78 µm; Biosimilar: from 315.03 ± 44.20 µm to 271.12 ± 20.39 µm; (p > 0.05). The mean number of injections was 2.68 ± 0.51 in the Innovator Ranibizumab group and 2.71 ± 0.49 in the Biosimilar Ranibizumab group. IOP remained stable in both cohorts, and no significant ocular or systemic adverse events were observed.

Biosimilar ranibizumab demonstrated non-inferior visual and anatomical outcomes compared to innovator ranibizumab in the treatment of mCNVM, with a similar safety profile and treatment burden.