TY - JOUR
T1 - Aflibercept 2 mg biosimilar (Tyalia)—real-world experience from IRAN (ATRIA study)
AU - International Retina Biosimilar Study Group (Inter BIOS Group)
AU - Avadzadeh, Sahar
AU - Sharma, Ashish
AU - Parvaresh, Mohammad Mehdi
AU - Ghasemi Falavarjani, Khalil
AU - Lee, Christopher Seungkyu
AU - Sagong, Min
AU - Woo, Se Joon
AU - Hayashi, Atsushi
AU - Tsuboi, Kotaro
AU - Yanagisawa, Shuichiro
AU - Nakamura, Tomoko
AU - Ishida, Masaaki
AU - Ueda-Consolvo, Tomoko
AU - Zinkernagel, Martin S.
AU - Spitzer, Martin
AU - March, Francesc
AU - Grewal, Dilraj S.
AU - Eichenbaum, David
AU - Sridhar, Jayanth
AU - Hassan, Tarek
AU - Keane, Pearse A.
AU - DO, Diana V.
AU - Nguyen, Quan Dong
AU - Mruthyunjaya, Prithvi
AU - Parolini, Barbara
AU - Sarao, Valentina
AU - Wintergerst, Maximilian W.M.
AU - Peto, Tunde
AU - Rachitskaya, Aleksandra
AU - Boyer, David
AU - Hilely, Assaf
AU - Corradetti, Giulia
AU - Yannuzzi, Nicolas
AU - Tufail, Adnan
AU - Sakamoto, Taiji
AU - Holekemp, Nancy
AU - Baumal, Caroline
AU - Lanzetta, Paolo
AU - Bilgic, Alper
AU - Laurent, Kodjikian
AU - Özdek, Şengül
AU - Querques, Giuseppe
AU - Wakabayashi, Taku
AU - Sivaprasad, Sobha
AU - Holz, Frank G.
AU - Kaiser, Peter K.
AU - Khanani, Arshad M.
AU - Rezaei, Kourous A.
AU - Banker, Alay
AU - Chakraborty, Debdulal
N1 - Publisher Copyright:
© The Author(s), under exclusive licence to The Royal College of Ophthalmologists 2025.
PY - 2025
Y1 - 2025
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=105004355328&partnerID=8YFLogxK
U2 - 10.1038/s41433-025-03813-2
DO - 10.1038/s41433-025-03813-2
M3 - 学術論文
AN - SCOPUS:105004355328
SN - 0950-222X
JO - Eye (Basingstoke)
JF - Eye (Basingstoke)
M1 - 294
ER -
