Avadzadeh Sahar, Sharma Ashish, Parvaresh Mohammad Mehdi, Ghasemi Falavarjani Khalil
Faculty of Medicine, Tehran Medical Sciences, Islamic Azad University, Tehran, Iran.
Lotus Eye Hospital and Institute, Avinashi road, Coimbatore, TN, India.
Eye (Lond). 2025 May 3. doi: 10.1038/s41433-025-03813-2.
To evaluate the early real-world clinical outcomes regarding safety and efficacy after administering the aflibercept 2 mg biosimilar (Tyalia, Cinnagen, Tehran, Iran).
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.
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%).
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.
评估注射阿柏西普2mg生物类似药（Tyalia，Cinnagen，伊朗德黑兰）后早期真实世界中的安全性和有效性临床结果。
进行了一项回顾性、非对照观察性研究，共对148例患者的189只眼进行了499次Tyalia注射，适应证多样。所有患者均接受至少一次玻璃体内注射2mg Tyalia；分析纳入了102只患有新生血管性年龄相关性黄斑变性（n-AMD）的眼、67只患有糖尿病性黄斑水肿（DMO）的眼以及20只患有与黄斑水肿相关的视网膜静脉阻塞（RVO）的眼。
整个研究组的平均中心子野厚度（CST）从基线到最后一次随访时从408.8±155.1µ改善至353.4±142.4µ（p<0.001）。发现整个队列中最佳矫正视力稳定。不良事件（AE）总数为（0.4%）。
这个有限的早期系列的初步真实世界数据表明，在获批适应证范围内，Tyalia似乎与阿柏西普2mg原研药具有相似的临床疗效和安全性。然而，需要更多人群的长期数据来进一步强化本研究的结果。
