Ranibizumab biosimilar (Oceva) - real-world experience from India (RORE study).

BACKGROUND

To evaluate early real-world clinical outcomes on the safety and efficacy of the ranibizumab biosimilar (Oceva, Sun Pharmaceuticals, India).

RESEARCH DESIGN AND

METHODS

A multicenter, retrospective, uncontrolled observational study evaluating data from 404 eyes that received a total of 742 intravitreal injections of the ranibizumab biosimilar (Oceva 0.5 mg) across four centers in India, administered between August 2024 and May 2025 in variable approved and off label indications. Of the total eyes, 288 were treatment-naïve naïve, while 116 eyes were previously treated.

RESULTS

The mean (SD) follow-up was 14.39 ± 12.5 weeks. The mean BCVA improved significantly from 0.87 to 0.59 LogMAR (p < 0.0001; d = 0.61), and mean CFT reduced from 406.8 µm to 306.5 µm (p < 0.0001; d = 0.66). Naïve eyes showed greater improvements than previously treated ones. No serious ocular or systemic adverse events were observed.

CONCLUSIONS

The preliminary real-world data from this limited early series suggest that ranibizumab biosimilar (Oceva) appears to be efficacious and safe across the approved indications. However, long-term data with a larger population are needed to further strengthen the findings of this study.