Isfahan University of Medical Sciences

Science Communicator Platform

Stay connected! Follow us on X network (Twitter):
Share By
Evaluating the Efficacy and Safety of Aflibercept Biosimilar (P041) Compared With Originator Product in Patients With Neovascular Age-Related Macular Degeneration Publisher Pubmed



Karkhaneh R1 ; Faghihi H1 ; Riaziesfahani H1 ; Abrishami M2 ; Bazvand F1 ; Ebrahimiadib N3 ; Johari M4 ; Akhlaghi M5 ; Shoeibi N2 ; Norouzzadeh MH4 ; Ansari Astaneh MR2 ; Khojasteh H1 ; Imani Fooladi M1 ; Khodabande A1 Show All Authors
Authors
  1. Karkhaneh R1
  2. Faghihi H1
  3. Riaziesfahani H1
  4. Abrishami M2
  5. Bazvand F1
  6. Ebrahimiadib N3
  7. Johari M4
  8. Akhlaghi M5
  9. Shoeibi N2
  10. Norouzzadeh MH4
  11. Ansari Astaneh MR2
  12. Khojasteh H1
  13. Imani Fooladi M1
  14. Khodabande A1
  15. Ghassemi F1
  16. Khalili Pour E1
  17. Zarei M6
  18. Mirshahi A1
  19. Fazel F5
  20. Ashraf H4
  21. Hosseini SM2
  22. Dourandeesh M7
  23. Feghhi M8
  24. Alizadeh Y9
  25. Behboudi H7
  26. Azadi P10
  27. Sabzvari A11
  28. Kafi H12
  29. Ghasemi Falavarjani K13, 14

Source: Ophthalmology Retina Published:2024


Abstract

Objective: To assess the noninferiority of biosimilar aflibercept (P041, CinnaGen) to the originator aflibercept (AFL, Regeneron) in terms of efficacy, safety, and immunogenicity. Design: This was a phase Ш, 52-week, multicenter, randomized, double-masked, and active control trial involving eyes in a 1:1 ratio. Subjects: Patients with active subfoveal choroidal neovascularization secondary to age-related macular degeneration randomized into the 2 groups of P041 and AFL. Methods: Patients received an injection of aflibercept every 4 weeks for 3 doses, followed by administration every 8 weeks up to week 48. Main Outcome Measures: The primary outcome was the noninferiority analysis of eyes maintaining vision at week 52. Secondary outcomes included the changes in visual acuity and retinal thickness, safety evaluation, and immunogenicity during the study. Results: In total, 168 eyes of 168 patients were included. At week 52, the proportion of patients maintaining vision was 94.44% in the P041 group compared with 94.52% in the AFL group. The 95% confidence interval (CI) for the difference of maintaining vision from baseline did not exceed the predefined noninferiority margin of 10% (difference, −0.0008; 95% CI, −0.074 to 0.074; P = 0.98). Secondary outcomes indicated similar results in both arms (all P > 0.05). Safety measured outcomes and immunogenicity were similar between the 2 study groups. Conclusions: Biosimilar aflibercept was noninferior to AFL in eyes with neovascular age-related macular degeneration. Other efficacy and safety findings also indicated the similarity of 2 products. Financial Disclosures: Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article. © 2024 American Academy of Ophthalmology
Other Related Docs
4. Ocular Disorders in Renal Transplant Patients, Journal of Ophthalmic and Vision Research (2007)
13. Comparison of Applanation Tonometry With and Without Fluorescein, Journal of Isfahan Medical School (2011)
17. Effects of Propranolol in Patients With Central Serous Chorioretinopathy, Journal of Research in Medical Sciences (2008)