Ranibizumab Biosimilar Demonstrates Noninferiority to Innovator Counterpart Treating Myopic CNVM

A ranibizumab biosimilar, Razumab (Intas Pharmaceuticals), demonstrated noninferior visual and anatomical outcomes compared with its innovator counterpart (Lucentis, Accentrix; Genentech, Novartis) when treating patients with myopic choroidal neovascular membrane (mCNVM), according to clinical findings published in Clinical Ophthalmology.

The findings show support for payer adoption of the biosimilar as a cost-effective, high-quality alternative, especially for patients hindered by high costs or restricted resources.¹

mCNVM is a condition that can occur in patients with any degree of myopia, even in the absence of characteristic degenerative retinal changes. It is reported to affect about 5% to 11% of patients with pathologic myopia, and among these patients, about 62% developed the condition before 50 years of age. A diagnosis is considered for a middle-aged myope who presents with sudden vision loss, metamorphopsia, and typi­cal funduscopic changes. Diagnosis in elderly patients is often more challenging because other conditions that can lead to CNV—such as age-related macular degeneration—may also be present.²

Regarding treatment, ranibizumab is an FDA-approved anti-VEGF agent indicated for mCNVM. Bevacizumab (Avastin; Genentech) and aflibercept (Eylea; Regeneron) are also used off-label, and for those contraindicated for anti-VEGF treatments, verteporfin photodynamic therapy may be considered.²

For this study, the investigators assessed the efficacy and safety of the biosimilar Razumab compared with innovator ranibizumab in the treatment of mCNVM. This retrospective, multicenter study enrolled 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. Patients were eligible for inclusion if they were 18 years of age or older, had an axial length greater than 26.5 mm or a spherical equivalent to or greater than –6.00 D, had a diagnosis confirmed by multimodal imaging, and a minimum 12-month follow-up.¹

The assessed outcomes included change in best-corrected visual acuity (BCVA; ETDRS letters), central macular thickness (CMT), intraocular pressure (IOP), injection frequency, and safety profile.¹

For this study, a total of 80 eyes were analyzed and sorted into either group A, in which everyone received the innovator (n = 38), or group B, in which everyone received the biosimilar (n = 42). At the 12-month point, the mean BCVA was observed to improve 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 (p > .05). Additionally, CMT reduced significantly in both the innovator (332.03 ± 39.22 µm to 268.32 ± 18.78 µm) and biosimilar (315.03 ± 44.20 µm to 271.12 ± 20.39 µm) groups (p > .05). The mean number of injections was about 2.68 ± 0.51 and 2.71 ± 0.49 in the innovator and biosimilar groups, respectively. Generally, IOP remained stable in both cohorts, and no significant ocular or systemic adverse events were observed, reported the investigators.¹

Although the study was considered to be robust due to its multicenter, real-world design, the authors wrote there were a few limitations. The study was retrospective, meaning that long-term complications—such as the progression of chorioretinal atrophy or recurrence patterns—could not be fully assessed because of the relatively short 12-month follow-up period. Additionally, the findings are specific to the mCNVM indication; therefore, the authors warned that extrapolation to other retinal diseases should only be performed when supported by indication-specific data.¹

REFERENCES

1. Chakraborty D, Sinha TK, Sinha S, et al. Biosimilar Versus Innovator Ranibizumab in Myopic CNVM: Comparative Real-World Outcomes- The BRIM Study. Clin Ophthalmol. 2025:19:3741-3747. doi:10.2147/OPTH.S549744.

2. Perez D, Schwartz S, Loewenstein A. Myopic Choroidal Neovascularization. March 1, 2020. Accessed November 5, 2025. https://www.aao.org/eyenet/article/myopic-choroidal-neovascularization