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

Eye volume 39, pages 2159–2163 (2025)Cite this article

Subjects

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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Fig. 1: Representative Cases.

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Data availability

The data that support the findings of this study are not openly available due to reasons of sensitivity and are available from the corresponding author upon reasonable request. Data are located in controlled access data storage at Lotus Eye Hospital and Institute.

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Author information

Authors and Affiliations

  1. Faculty of Medicine, Tehran Medical Sciences, Islamic Azad University, Tehran, Iran

    Sahar Avadzadeh

  2. Lotus Eye Hospital and Institute, Avinashi road, Coimbatore, TN, India

    Ashish Sharma

  3. Eye Research Center, The Five Senses Health Institute, Moheb Kowsar Hospital, School of Medicine, Iran University of Medical Sciences, Tehran, Iran

    Mohammad Mehdi Parvaresh & Khalil Ghasemi Falavarjani

  4. Stem Cell and Regenerative Medicine Research Center, Iran University of Medical Sciences, Tehran, Iran

    Khalil Ghasemi Falavarjani

  5. Gavin Herbert Eye Institute, University of California, Irvine, Irvine, CA, USA

    Baruch D. Kuppermann

  6. Division of Ophthalmology, Tel Aviv Sourasky Medical Center, Tel Aviv University, Tel Aviv, Israel

    Anat Loewenstein

  7. Department of Ophthalmology, Scientific Institute San Raffaele, University Vita-Salute, Milano, Italy

    Francesco Bandello

  8. Mid Atlantic Retina, The Retina Service of Wills Eye Hospital, Philadelphia, PA, USA

    Carl D. Regillo

  9. Moorfields Eye Hospital NHS FT, London, UK

    Luke Nicholson & Adnan Tufail

  10. Royal Eye Unit, Kingston Hospital NHSFT, London, UK

    Clara Vazquez-Alfageme

  11. Madhavi Netralaya, Ara, Bihar, India

    Nilesh Kumar

  12. Aster Hospital Sharjah, Sharjah, UAE

    Nikulaa Parachuri

  13. Department of Retina Services, Shantilal Shanghvi Eye Institute (SSEI), Mumbai, India

    Jay Sheth

  14. Dr. P.S. Hardia Eye Hospital and Research Center, Rau, Indore, India

    Seemantini Ayachit

  15. Trilochan Netralaya, Sambalpur, Odisha, India

    Chitaranjan Mishra

  16. Department of Vitreoretinal Services, Disha Eye Hospitals, Kolkata, West Bengal, India

    Debdulal Chakraborty

  17. Banker’s Retina Clinic and Laser Centre, Ahmedabad, India

    Alay Banker

  18. Illinois Retina Associates, Chicago, IL, USA

    Kourous A. Rezaei

  19. Sierra Eye Associates, Reno, NV, USA & The University of Nevada, Reno School of Medicine, Reno, NV, USA

    Arshad M. Khanani

  20. Cole Eye Institute, Cleveland Clinic Foundation, Cleveland, OH, USA

    Peter K. Kaiser

  21. Department of Ophthalmology, University of Bonn, Bonn, Germany

    Frank G. Holz

  22. NIHR Moorfields Biomedical Research Centre, Moorfields Eye Hospital and UCL, London, UK

    Sobha Sivaprasad

  23. Wakabayashi Eye Clinic, Nonoichi, Ishikawa, Japan

    Taku Wakabayashi

  24. Department of Ophthalmology; University Vita-Salute, Scientific Institute San Raffaele, Milano, Italy

    Giuseppe Querques

  25. Ophthalmology Department, Gazi University School of Medicine, Besevler, Ankara, Turkey

    Şengül Özdek

  26. Department of Ophthalmology, Croix-Rousse University Hospital, Hospices Civils de Lyon, 69004, Lyon, France & UMR5510 MATEIS, CNRS, INSA Lyon, Université de Lyon 1, 69100, Villeurbanne, France

    Kodjikian Laurent

  27. Augen Zentrum Gutenberg AG, Bern, Switzerland

    Alper Bilgic

  28. Department of Ophthalmology, University of Udine, Udine, Italy

    Paolo Lanzetta & Valentina Sarao

  29. Tufts University School of Medicine, New England Eye Center, Boston, MA, USA

    Caroline Baumal

  30. Roche Pharmaceuticals, Basel, Switzerland

    Nancy Holekemp

  31. Department of Ophthalmology, Kagoshima University, Kagoshima, Japan

    Taiji Sakamoto

  32. Department of Ophthalmology, Bascom Palmer Eye Institute, Miami, FL, USA

    Nicolas Yannuzzi & Jayanth Sridhar

  33. Doheny Eye Institute, Pasadena, CA, USA

    Giulia Corradetti

  34. Division of Ophthalmology, Tel Aviv Medical, Tel Aviv University, Tel Aviv, Israel

    Assaf Hilely

  35. Retina Vitreous Associates Medical Group, Los Angeles, Los Angeles, CA, USA

    David Boyer

  36. Cole Eye Institute, Cleveland Clinic, Cleveland, OH, USA

    Aleksandra Rachitskaya

  37. Centre for Public Health, Queen’s University Belfast, Belfast, UK

    Tunde Peto

  38. Department of Ophthalmology, University Hospital Bonn, Venusberg-Campus 1, 53127, Bonn, Germany

    Maximilian WM Wintergerst

  39. Istituto Clinico S. Anna, Via del Franzone, 31, 25127, Brescia, Brescia, Italy

    Barbara Parolini

  40. Spencer Center for Vision Research, Byers Eye Institute, Stanford University, Palo Alto, CA, USA

    Prithvi Mruthyunjaya

  41. Byers Eye Institute, Stanford University, Palo Alto, CA, USA

    Quan Dong Nguyen & Diana V. DO

  42. NIHR Biomedical Research Centre at Moorfields, Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, UK

    Pearse A. Keane

  43. Associated Retinal Consultants PC, Royal Oak, MI, USA & Oakland University William Beaumont School of Medicine, Royal Oak, MI, USA

    Tarek Hassan

  44. Retina Vitreous Associates of Florida, Tampa, FL, USA

    David Eichenbaum

  45. Department of Ophthalmology, Duke University School of Medicine, Durham, NC, USA

    Dilraj S. Grewal

  46. University of Otago, Dunedin, New Zealand & University of Girona, Girona, Spain

    Francesc March

  47. Klinik und Poliklinik für Augenheilkunde, Universitätsklinikum Hamburg-Eppendorf (UKE), Martinistr. 52, 20246, Hamburg, Deutschland

    Martin Spitzer

  48. Department for BioMedical Research, University of Bern, Murtenstrasse 24, CH-3008, Bern, Switzerland & Department of Ophthalmology, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 15, CH-3010, Bern, Switzerland

    Martin S. Zinkernagel

  49. Department of Ophthalmology, Graduate School of Medicine and Pharmaceutical Sciences, University of Toyama, Toyama, Japan

    Tomoko Ueda-Consolvo, Masaaki Ishida, Tomoko Nakamura, Shuichiro Yanagisawa & Atsushi Hayashi

  50. Department of Ophthalmology, Aichi Medical University, Nagakute, Aichi, Japan

    Kotaro Tsuboi

  51. Department of Ophthalmology, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea

    Se Joon Woo

  52. Yeungnam Eye Center, Yeungnam University Hospital, Daegu, Korea

    Min Sagong

  53. Institute of Vision Research, Department of Ophthalmology, Severance Eye Hospital, Yonsei University College of Medicine, Seoul, Korea

    Christopher Seungkyu Lee

Authors
  1. Sahar Avadzadeh
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  2. Ashish Sharma
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  3. Mohammad Mehdi Parvaresh
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  4. Khalil Ghasemi Falavarjani
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Consortia

International Retina Biosimilar Study Group (Inter BIOS Group)

  • 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

Contributions

KGF: conception, analysis, drafting, integrity check, final approval. SA, AS, MMP: data, drafting, revision, analysis, integrity check.

Corresponding author

Correspondence to Ashish Sharma.

Ethics declarations

Competing interests

KGF: Consultant for CinnaGen. Ashish Sharma: Consultant for Bayer, Lupin, Novartis, Allergan, Roche and Intas. SA and MMP: None.

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Avadzadeh, S., Sharma, A., Parvaresh, M.M. et al. Aflibercept 2 mg biosimilar (Tyalia)—real-world experience from IRAN (ATRIA study). Eye 39, 2159–2163 (2025). https://doi.org/10.1038/s41433-025-03813-2

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  • DOI: https://doi.org/10.1038/s41433-025-03813-2

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