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

Avadzadeh, S; Sharma, A; Parvaresh, MM; Ghasemi Falavarjani, K; Lee, CS; Sagong, M; Woo, SJ; ... Kuppermann, BD; + view all (2025) Aflibercept 2 mg biosimilar (Tyalia)—real-world experience from IRAN (ATRIA study). Eye 10.1038/s41433-025-03813-2. (In press).

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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.

Type: Article
Title: Aflibercept 2 mg biosimilar (Tyalia)—real-world experience from IRAN (ATRIA study)
DOI: 10.1038/s41433-025-03813-2
Publisher version: https://doi.org/10.1038/s41433-025-03813-2
Language: English
Additional information: This version is the author accepted manuscript. For information on re-use, please refer to the publisher's terms and conditions.
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences > Institute of Ophthalmology
URI: https://discovery.ucl.ac.uk/id/eprint/10209398
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