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. 2025 Feb 27:24741264251322213.
doi: 10.1177/24741264251322213. Online ahead of print.

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

Affiliations

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

Ashish Sharma et al. J Vitreoretin Dis. .

Abstract

Purpose: To evaluate the early real-world clinical outcomes regarding the safety and efficacy after administration of a ranibizumab biosimilar (Ranieyes). Methods: 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. Results: 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) (z = -8.0; r = -0.8); MNV cases, from 0.95 ± 0.53 (6/60) to 0.59 ± 0.42 (6/24) (z = -7.1; r = -0.8); RVO cases, from 0.83 ± 0.40 (6/45) to 0.44 ± 0.32 (6/15) (z = -5.5; r = -0.8) (all P < .001). All groups also had significant improvement in the central subfield thickness (all P < .001). No site reported drug-related adverse events (eg, inflammation, vasculitis, systemic adverse effects). Conclusions: 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.

Keywords: Ranieyes; anti-VEGF; biosimilars; ophthalmology; ranibizumab; retina.

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Conflict of interest statement

The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of the article: Dr. Sharma is a consultant to Allergan, Bayer, Intas, Lupin, and Novartis. Dr. Holz reported research grants and personal fees from Acucela, Allergan, Apellis, Bayer, Bioeq/Formycon, Geuder, Heidelberg Engineering, Iveric Bio, Novartis, Pixium Vision, Roche/Genentech, and Zeiss and personal fees from Aerie, Alexion, Grayburg Vision, LinBioscience, Oxurion, and Stealth BioTherapeutics. Dr. Kumar is a consultant to Intas and Lupin. Dr. Sarraf has or had an affiliation (financial or otherwise) with Amgen, Bayer, Genentech, Heidelberg, Novartis, Optovue, Regeneron, and Topcon; is a consultant to Iveric Bio; and received a research grant from Boehringer. Dr. Tufail is a consultant to Apellis, Adverum, Allergan, Bayer, Boehringer-Ingelheim, Heidelberg Engineering, Hofmann La Roche, Iveric Bio, Novartis, Samsung, and Thrombogenics. Dr. Rachitskaya is a consultant to and speaker for Apellis, Genentech Roche, Novartis, and Regeneron. Dr. Eichenbaum is a consultant to Alimera, Allergan, Apellis, Bausch + Lomb, Dutch Ophthalmic, EyePoint, Genentech Inc, Gyroscope, Iveric Bio, KKR, Kodiak, Novartis, Recens Medical, Regeneron, RegenxBio, and Vial; has equity in and/or is a stockholder in Boston Image Reading Center, Clearside, Hemera, Network Eye, and US Retina; is the founder of Network Eye; is an investigator for Alkahest, Annexon, AsclepiX, Bayer, Chengdu, EyePoint, Gemini, Genentech Inc, Gyroscope, Ionis, Iveric Bio, Kodiak, Mylan, NGM, Novartis, Ocular Therapeutix, Ophthea, Recens Medical, Regeneron, RegenxBio, and Unity; and is a speaker for Allergan, Apellis, Bayer, Dutch Ophthalmic, EyePoint, Genentech Inc, and Novartis. Dr. Loewenstein is a consultant to and speaker for Allergan, Bayer Health Care, Beyeonics, Forsightslabs, Novartis, Notal Vision, Regeneron, and Roche. Dr. Bandello is a consultant to Allergan, Bayer, Boehringer-Ingelheim, Fidia Sooft, Hofmann La Roche, Novartis, NTC Pharma, Sifi, Thrombogenics, and Zeiss. Dr Woo is a consultant to Panolos Bioscience and Samsung Bioepis; is a cofounder of Retimark; is on advisory board of Novartis and Novelty Nobility; has received grants and personal fees from Alteogen, Curacle, Kookje, Novartis, Novelty Nobility, and Samsung Bioepis; and has received lecture fees from AbbVie, Alcon, Allergan, Alteogen, Bayer, Novartis, SCAI Therapeutics, and Taejoon. Dr. Kuppermann is a clinical researcher for Alcon, Alimera, Allegro, Allergan, Apellis, Clearside, Genentech, GSK, Ionis, jCyte, Novartis, Regeneron, and ThromboGenics and is a consultant to Alimera, Allegro, Allergan, Cell Care, Dose, Eyedaptic, Galimedix, Genentech, Glaukos, Interface Biologics, jCyte, Novartis, Ophthotech, Regeneron, Revana, and Theravance Biopharma. None of the other authors declared potential conflicts of interest with respect to the research, authorship, and/or publication of the article.

Figures

Figure 1.
Figure 1.
(A) Representative case of diabetic macular edema (DME) (left) at baseline and (right) 4 weeks after a single Ranieyes injection, showing complete resolution of the DME. (B) Representative case of neovascular age-related macular degeneration with the subretinal fluid (SRF) (left) at baseline and (right) 4 weeks after a single Ranieyes injection, showing complete resolution of the SRF. (C) Representative case of branch retinal vein occlusion with cystoid macular edema (CME) (left) at baseline and (right) 4 weeks after a single Ranieyes injection, showing complete resolution of the CME.

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