Innovator ranibizumab (IR) received the United States Food and Drug Administration (US-FDA) approval in 2006 and the European Medical Agency (EMA) approval in 2007 [1, 2]. Ranibizumab biosimilar {Razumab (RB) Intas Pharmaceuticals Ltd, India} was approved by the drug controller general of India (DGCI) in 2015 [3]. Since then, Razumab has been widely implemented in India as a cost-effective treatment option. There are multiple single-arm scientific studies that have been published related to the efficacy and safety of RB [4,5,6,7,8,9]. However, to the best of our knowledge, no comparative data on RB vs IR has been published yet. This is the first study that compares the efficacy and safety of RB vs IR in neovascular age-related macular degeneration (n-AMD).

We retrospectively reviewed charts of treatment naïve n-AMD patients who were treated with at least 2 consecutive injections at 4 weeks interval with either 0.5 mg of RB or IR between Dec 2018 and Dec 2020. We found 42 eyes in the RB group and 44 eyes in the IR group to be eligible for analysis according to the inclusion criteria. The methodology adhered to the tenets of the declaration of Helsinki. Institute’s committee on human research approved the protocol. Informed consent was taken as per the routine protocol of the institute regarding data utilization for the research purpose. A minimum of 8-week follow-up from the time of diagnosis of n-AMD was required to be included in the study. Eyes with structural changes other than n-AMD and patients with vitreo-retinal interface diseases were excluded. Furthermore, patients who were switched to another drug in any of the groups during the initial 6 months were also excluded. Each patient underwent best-corrected visual acuity (BCVA) measurement with Snellen chart {converted to Early Treatment Diabetic Retinopathy Study (ETDRS) letter score for analysis}, central subfield thickness (CST) with spectral-domain optical coherence tomography (SD-OCT) (Optovue Fremont, CA, USA) and intraocular pressure (IOP) measurement along with complete ophthalmic examination at each follow-up visit. Follow-up visit at 8 weeks was considered as the primary outcome for efficacy and safety. Further analysis of safety and efficacy was performed at 24 weeks. Efficacy was determined on the basis of comparison of BCVA and CMT. Safety was assessed on the basis of the occurrence of ocular or systemic adverse events noted at each follow-up visit. Amongst safety, predominantly clinical immunogenicity was tested and it was considered positive if the clinician (AS) had documented any anterior chamber inflammation (cells/flare) and/OR posterior chamber inflammation (vitritis/ snow banking/ snow balls/ retinitis/ retinal vasculitis) during any of the visits. Otherwise, it was considered negative. Descriptive statistics including mean, standard deviation (SD), median, and range were calculated for continuous variables. Unpaired t-test was used to measure mean differences between RB and IR. The Chi-square test was used for the comparison of categorical data. The baseline data were matched in terms of age, BCVA, and CMT.

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