Pooled Multicenter Safety Analysis of Lupin's Intravitreal Biosimilar Ranibizumab (Ranieyes) in Chorioretinal Vascular Diseases.

IF 2.6 3区医学 Q2 OPHTHALMOLOGY

Ophthalmology and Therapy Pub Date : 2024-11-19 DOI:10.1007/s40123-024-01065-z

Debdulal Chakraborty, Tushar Kanti Sinha, Sourav Sinha, Aniruddha Maiti, Angshuman Mukherjee, Krishnendu Nandi, Sudipta Das, Saptorshi Majumdar, Dinesh Rungta, Ranabir Bhattacharya

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引用次数: 0

Abstract

Introduction: This study aims to evaluate the ocular and systemic safety profiles of intravitreal biosimilar ranibizumab Ranieyes (Lupin Pharmaceuticals, Mumbai, India) in real-world clinical settings across multiple chorioretinal vascular diseases, including neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), and retinal vein occlusion (RVO) in adults.

Methods: We conducted a retrospective, consecutive, interventional, uncontrolled multicenter study using data from three hospital networks in India. A total of 1401 eyes received 2194 injections of Ranieyes between June 2022 and November 2023. Patients were followed for a minimum of 6 months, and data on ocular and systemic adverse events (AEs) were collected and analyzed.

Results: The study population included 636 male patients and 533 female patients, with a mean age of 58.63 ± 11.54 years. The average number of injections per eye was 1.49 ± 0.23, with the highest frequency in the nAMD group (mean of 2.3 ± 0.23 injections per eye) over 6 months. Non-serious adverse events (nsAEs) were observed in 26.83% of injections, with mild ocular pain and transient blurring of vision being the most common. Serious ocular adverse events were rare, occurring in 0.85% of eyes, with retinal pigment epithelial tear (RPE TEAR) being the most frequent. Systemic adverse events were noted in 5.03% of patients, and all but one were non-serious. One patient developed non-fatal myocardial infarction, the causal relationship of which, however, was not established with the intravitreal agent used. No cases of endophthalmitis were observed.

Conclusions: This large-scale, real-world study demonstrates that Ranieyes is a safe intravitreal antivascular endothelial growth factor (anti-VEGF) agent across various chorioretinal vascular diseases. The safety profile of Ranieyes is consistent with that of the reference product, making it a viable option in resource-constrained settings.

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罗平公司的雷珠单抗（Ranieyes）静脉注射生物仿制药在脉络膜视网膜血管疾病中的多中心汇总安全性分析。

研究简介本研究旨在评估玻璃体内生物仿制药 Ranieibizumab（Lupin Pharmaceuticals，印度孟买）在实际临床环境中治疗多种脉络膜视网膜血管疾病（包括成人新生血管性年龄相关性黄斑变性（nAMD）、糖尿病性黄斑水肿（DME）和视网膜静脉闭塞（RVO））的眼部和全身安全性：我们利用印度三个医院网络的数据开展了一项回顾性、连续性、介入性、非对照多中心研究。在 2022 年 6 月至 2023 年 11 月期间，共有 1401 只眼睛接受了 2194 次 Ranieyes 注射。对患者进行了至少 6 个月的随访，并收集和分析了有关眼部和全身不良事件（AEs）的数据：研究对象包括 636 名男性患者和 533 名女性患者，平均年龄（58.63±11.54）岁。每只眼睛的平均注射次数为（1.49 ± 0.23）次，在 6 个月内，nAMD 组的注射次数最多（每只眼睛的平均注射次数为（2.3 ± 0.23）次）。在 26.83% 的注射中观察到了非严重不良事件（nsAEs），其中最常见的是轻微眼痛和一过性视力模糊。严重的眼部不良事件很少发生，仅占 0.85%，其中最常见的是视网膜色素上皮撕裂（RPE TEAR）。5.03%的患者出现了全身不良反应，除一人外，其余均为非严重不良反应。一名患者发生了非致命性心肌梗死，但与所使用的玻璃体内药物的因果关系并不确定。没有观察到眼内炎病例：这项大规模真实世界研究表明，Ranieyes 是一种安全的玻璃体内抗血管内皮生长因子（anti-VEGF）药物，适用于各种脉络膜视网膜血管疾病。Ranieyes 的安全性与参比产品一致，因此在资源有限的情况下是一种可行的选择。

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来源期刊

Ophthalmology and Therapy OPHTHALMOLOGY-

CiteScore

4.20

自引率

3.00%

发文量

157

审稿时长

6 weeks

期刊介绍： Aims and Scope Ophthalmology and Therapy is an international, open access, peer-reviewed (single-blind), and rapid publication journal. The scope of the journal is broad and will consider all scientifically sound research from preclinical, clinical (all phases), observational, real-world, and health outcomes research around the use of ophthalmological therapies, devices, and surgical techniques. The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports/series, trial protocols and short communications such as commentaries and editorials. Ophthalmology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of quality research, which may be considered of insufficient interest by other journals. Rapid Publication The journal’s publication timelines aim for a rapid peer review of 2 weeks. If an article is accepted it will be published 3–4 weeks from acceptance. The rapid timelines are achieved through the combination of a dedicated in-house editorial team, who manage article workflow, and an extensive Editorial and Advisory Board who assist with peer review. This allows the journal to support the rapid dissemination of research, whilst still providing robust peer review. Combined with the journal’s open access model this allows for the rapid, efficient communication of the latest research and reviews, fostering the advancement of ophthalmic therapies. Open Access All articles published by Ophthalmology and Therapy are open access. 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