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Purpose <p>To evaluate the early real-world clinical outcomes regarding safety and efficacy after administering the aflibercept 2 mg biosimilar (Tyalia, Cinnagen, Tehran, Iran).</p> Methods <p>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.</p> Results <p>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 (<i>p</i> &lt; 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%).</p> Conclusions <p>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.</p>

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

  • 期刊论文

  • 发表日期：

    2025年5月3日

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  • Sahar Avadzadeh,
  • Ashish Sharma,
  • Mohammad Mehdi Parvaresh,
  • Khalil Ghasemi Falavarjani,
  • Baruch D. Kuppermann,
  • Anat Loewenstein,
  • Francesco Bandello,
  • Carl D. Regillo,
  • Luke Nicholson,
  • Clara Vazquez-Alfageme,
  • Nilesh Kumar,
  • Nikulaa Parachuri,
  • Jay Sheth,
  • Seemantini Ayachit,
  • Chitaranjan Mishra,
  • Debdulal Chakraborty,
  • Alay Banker,
  • Kourous A. Rezaei,
  • Arshad M. Khanani,
  • Peter K. Kaiser,
  • Frank G. Holz,
  • Sobha Sivaprasad,
  • Taku Wakabayashi,
  • Giuseppe Querques,
  • Şengül Özdek,
  • Kodjikian Laurent,
  • Alper Bilgic,
  • Paolo Lanzetta,
  • Caroline Baumal,
  • Nancy Holekemp,
  • Taiji Sakamoto,
  • Adnan Tufail,
  • Nicolas Yannuzzi,
  • Giulia Corradetti,
  • Assaf Hilely,
  • David Boyer,
  • Aleksandra Rachitskaya,
  • Tunde Peto,
  • Maximilian WM Wintergerst,
  • Valentina Sarao,
  • Barbara Parolini,
  • Prithvi Mruthyunjaya,
  • Quan Dong Nguyen,
  • Diana V. DO,
  • Pearse A. Keane,
  • Tarek Hassan,
  • Jayanth Sridhar,
  • David Eichenbaum,
  • Dilraj S. Grewal,
  • Francesc March,
  • Martin Spitzer,
  • Martin S. Zinkernagel,
  • Tomoko Ueda-Consolvo,
  • Masaaki Ishida,
  • Tomoko Nakamura,
  • Shuichiro Yanagisawa,
  • Kotaro Tsuboi,
  • Atsushi Hayashi,
  • Se Joon Woo,
  • Min Sagong,
  • Christopher Seungkyu Lee

摘要

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.