Biosimilar Ranibizumab (Ranieyes) Safety and Efficacy in the Real World: BRESER Study

Area of Science:

• Ophthalmology
• Retinal diseases
• Pharmacology

Background:

• Ranibizumab is a key treatment for neovascular age-related macular degeneration and other retinal conditions.
• The development of biosimilars offers potential for cost-effective alternatives in ophthalmic treatments.
• Real-world data is crucial for understanding the clinical utility of new therapeutic agents like biosimilars.

Purpose of the Study:

• To assess the early clinical outcomes, focusing on safety and efficacy, of the ranibizumab biosimilar Ranieyes.
• To evaluate Ranieyes in a real-world setting across diverse ophthalmic indications.

Main Methods:

• A multicenter, retrospective, uncontrolled observational study was conducted across 7 centers in India.
• Data from 254 patients (268 eyes) receiving at least one intravitreal injection of 0.5 mg Ranieyes between July 2022 and July 2023 were analyzed.
• Indications included diabetic macular edema (DME), macular neovascularization (MNV), and retinal vein occlusion (RVO), among others.

Main Results:

• Significant improvements in best-corrected visual acuity (BCVA) were observed across all major indication groups (DME, MNV, RVO) from baseline to last follow-up (P < .001).
• Central subfield thickness also showed significant reduction in all patient groups (P < .001).
• No drug-related adverse events, such as inflammation, vasculitis, or systemic effects, were reported by any participating site.

Conclusions:

• Preliminary real-world evidence suggests Ranieyes demonstrates clinical efficacy in treating various retinal conditions.
• The ranibizumab biosimilar Ranieyes appears to be safe for use in clinical practice.
• These early findings support the use of Ranieyes as a viable ranibizumab biosimilar option.