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

27/02/2025

Journal of vitreoretinal diseases

Authors: Ashish Sharma, Frank G Holz, Nilesh Kumar, David Sarraf, Seemantini Ayachit, Chitaranjan Mishra, Adnan Tufail, Debdulal Chakraborty, Aleksandra Rachitskaya, David Eichenbaum, Alay Banker, Nikulaa Parachuri, Ashish Kumar, Anat Loewenstein, Francesco Bandello, Taku Wakabayashi, Se Joon Woo, Baruch D Kuppermann

To evaluate the early real-world clinical outcomes regarding the safety and efficacy after administration of a ranibizumab biosimilar (Ranieyes). This multicenter retrospective uncontrolled observational study incorporated data from 7 centers in India. All patients were treated with at least 1 intravitreal injection of 0.5 mg of ranibizumab biosimilar between July 2022 and July 2023 for various indications. A total of 474 ranibizumab biosimilar injections were given in 268 eyes of 254 patients. Indications were diabetic macular edema (DME) (n = 112), macular neovascularization (MNV) (n = 92), retinal vein occlusion (RVO) (n = 54), cystoid macular edema (n = 4), and proliferative diabetic retinopathy with vitreous hemorrhage (n = 6). The mean logMAR BCVA (±SD) improved significantly from baseline to the last follow-up as follows: DME cases, from 0.77 ± 0.37 (Snellen equivalent, 6/36) to 0.43 ± 0.25 (6/15) ( = -8.0; = -0.8); MNV cases, from 0.95 ± 0.53 (6/60) to 0.59 ± 0.42 (6/24) ( = -7.1; = -0.8); RVO cases, from 0.83 ± 0.40 (6/45) to 0.44 ± 0.32 (6/15) ( = -5.5; = -0.8) (all < .001). All groups also had significant improvement in the central subfield thickness (all < .001). No site reported drug-related adverse events (eg, inflammation, vasculitis, systemic adverse effects). The preliminary real-world data from this limited early series suggest that Ranieyes has clinical efficacy and is safe as a ranibizumab biosimilar across the approved indications.

PMID: 40028177