Aflibercept 2 mg biosimilar (Tyalia)-real-world experience from IRAN (ATRIA study).

IF 2.8 3区医学 Q1 OPHTHALMOLOGY

Eye Pub Date : 2025-05-03 DOI:10.1038/s41433-025-03813-2

Sahar Avadzadeh, Ashish Sharma, Mohammad Mehdi Parvaresh, Khalil Ghasemi Falavarjani

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引用次数: 0

Abstract

Purpose: To evaluate the early real-world clinical outcomes regarding safety and efficacy after administering the aflibercept 2 mg biosimilar (Tyalia, Cinnagen, Tehran, Iran).

Methods: A retrospective, uncontrolled observational study was conducted with a total of 499 Tyalia injections given in 189 eyes of 148 patients for variable indications. All patients were treated with at least one intravitreal injection of Tyalia 2 mg; 102 eyes with neovascular age-related macular degeneration (n-AMD), 67 eyes with diabetic macular oedema (DMO), and 20 eyes with retinal vein occlusion (RVO) associated with macular oedema were included in the analysis.

Results: The mean central subfield thickness (CST) of the overall group improved from baseline to the last follow-up from 408.8 ± 155.1 µ to 353.4 ± 142.4 µ (p < 0.001). Best corrected visual acuity was found to be stable in the total cohort. The total number of adverse events (AEs) was (0.4%).

Conclusions: The preliminary real-world data from this limited early series suggest that Tyalia appears to have similar clinical efficacy and safety as aflibercept 2 mg innovator across the approved indications. However, long-term data with a larger population are needed to further strengthen the findings of this study.

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afliberept 2 mg生物类似药(Tyalia)-来自伊朗的真实世界经验（ATRIA研究）。

目的：评估使用afliberept 2mg生物类似药后的早期真实世界临床结果的安全性和有效性（Tyalia, Cinnagen，德黑兰，伊朗）。方法：回顾性、非对照观察性研究，对148例不同适应症患者189只眼进行499次Tyalia注射。所有患者均接受至少一次Tyalia 2 mg玻璃体内注射治疗；102只新生血管性年龄相关性黄斑变性（n-AMD）眼、67只糖尿病性黄斑水肿（DMO）眼和20只视网膜静脉闭塞（RVO）伴黄斑水肿眼纳入分析。结果：从基线到最后一次随访，整个组的平均中心亚野厚度（CST）从408.8±155.1µ提高到353.4±142.4µ(p)。结论：这个有限的早期系列的初步真实世界数据表明，在批准的适应症中，Tyalia似乎与阿伯西普2mg innovator具有相似的临床疗效和安全性。然而，需要更大人群的长期数据来进一步加强本研究的结果。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Eye 医学-眼科学

CiteScore

6.40

自引率

5.10%

发文量

481

审稿时长

3-6 weeks

期刊介绍： Eye seeks to provide the international practising ophthalmologist with high quality articles, of academic rigour, on the latest global clinical and laboratory based research. Its core aim is to advance the science and practice of ophthalmology with the latest clinical- and scientific-based research. Whilst principally aimed at the practising clinician, the journal contains material of interest to a wider readership including optometrists, orthoptists, other health care professionals and research workers in all aspects of the field of visual science worldwide. Eye is the official journal of The Royal College of Ophthalmologists. Eye encourages the submission of original articles covering all aspects of ophthalmology including: external eye disease; oculo-plastic surgery; orbital and lacrimal disease; ocular surface and corneal disorders; paediatric ophthalmology and strabismus; glaucoma; medical and surgical retina; neuro-ophthalmology; cataract and refractive surgery; ocular oncology; ophthalmic pathology; ophthalmic genetics.