Ranizurel safety evaluation in real-world -(RaSER) study

Abstract

Purpose: To assess the early real-world clinical outcomes regarding safety and efficacy after ranizurel administration. Methods: A retrospective, consecutive, interventional, uncontrolled, multi-centre study was conducted incorporating data from four centres in India. 22 eyes with variable indications were included and all patients were treated with at least one intravitreal injection of ranizurel 0.5 mg between January 2021 and April 2021. Each patient underwent best-corrected visual acuity (BCVA) measurement with a Snellen chart (converted to LogMAR for analysis), central subfield thickness (CST) analysis with spectral-domain optical coherence tomography (SD-OCT) and intraocular pressure (IOP) measurement along with complete ophthalmic examination at baseline and the last follow-up for evaluation of adverse events after ranizurel injection. Results: – None of the sites reported any signs of inflammation, vasculitis or any other ocular or systemic adverse effects in any of the cases. Mean BCVA at baseline was 0.48 ± 0.26 LogMAR (20/63) which improved significantly 0.26 ± 0.28 (20/40) at the last follow-up. (p = 0.001) Mean CST at baseline was 448.4 ± 122.9 μm which improved significantly to 328.3 ± 89.9 μm. (p = 0.001). Conclusion: – The early real-world data from this limited series indicates that ranizurel is a safe alternative biologic for patients who were treatment-naive and in those who had undergone prior treatment with other anti-VEGF agents.

Keywords

• RanizuRel
• Biosimilar
• Real world
• Early experience
• Anti-VEGF