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Mirshahi A, Lashay A, Riazi-Esfahani H, Ebrahimiadib N, Khojasteh H, Ghassemi F, Bazvand F, Khodabande A, Roohipour R, Khalili Pour E, Faghihi H. Intraocular Injection of Stivant® (A Biosimilar to Bevacizumab): A Case Series. JOVR [Internet]. 2021Jan.20 [cited 2024May4];16(1):28–33. Available from: https://knepublishing.com/index.php/JOVR/article/view/8248

https://doi.org/10.18502/jovr.v16i1.8248

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authors

  • Ahmad Mirshahi

    Ahmad Mirshahi

    Translational Ophthalmology Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran
  • Alireza Lashay

    Alireza Lashay

    Translational Ophthalmology Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran
  • Hamid Riazi-Esfahani

    Hamid Riazi-Esfahani

    Translational Ophthalmology Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran
  • Nazanin Ebrahimiadib

    Nazanin Ebrahimiadib

    Translational Ophthalmology Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran
  • Hassan Khojasteh

    Hassan Khojasteh

    Translational Ophthalmology Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran
  • Fariba Ghassemi

    Fariba Ghassemi

    Translational Ophthalmology Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran
  • Fatemeh Bazvand

    Fatemeh Bazvand

    Translational Ophthalmology Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran
  • Alireza Khodabande

    Alireza Khodabande

    Translational Ophthalmology Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran
  • Ramak Roohipour

    Ramak Roohipour

    Translational Ophthalmology Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran
  • Elias Khalili Pour

    Elias Khalili Pour

    Translational Ophthalmology Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran
  • Hooshang Faghihi

    Hooshang Faghihi

    Translational Ophthalmology Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran

Published Date

  • Jan 20, 2021
This journal is publishing all the articles under Creative Commons Attribution License CC BY 4.0.

Intraocular Injection of Stivant® (A Biosimilar to Bevacizumab): A Case Series

Journal of Ophthalmic and Vision Research (JOVR) / January–March 2021, Volume 16, Issue 1 / Pages 28–33

Abstract

Purpose: To report the results of intravitreal injection of a bevacizumab biosimilar called Stivant®.


Methods: This prospective interventional case series was conducted on eyes with neovascular age-related macular degeneration (nAMD), retinal vein occlusion (RVO), and diabetic macular edema (DME). Stivant® was injected in three consecutive months and changes in best-corrected visual acuity (BCVA) and central macular thickness (CMT) were measured at baseline and monthly up to one month after the third injection.


Results: Three hundred and eighty-five eyes with DME (234 eyes, 61%), nAMD (87 eyes, 22%), and macular edema secondary to RVO (64 eyes, 17%) were enrolled. The mean ± standard deviation age of the patients was 61.7 ± 7.20 years. The mean BCVA and CMT changed from 0.63 ± 0.3 to 0.51 ± 0.3 LogMAR (P = 0.12 ) and from 420.4 ± 47.3μm at baseline to 316.7 ± 50.6 μm (P < 0.001) in the DME group; from 0.79 ± 0.3 to 0.68 ± 0.3 LogMAR (P = 0.19) and from 376.1 ± 31.7 μm to 303 ± 31.3 μm (P = 0.019) in the nAMD group; and from 0.81 ± 0.4 to 0.63 ± 0.4 LogMAR (P = 0.05) and from 424.21 ± 18 μm to 303.4 ± 18.8 μm (P < 0.001) in the RVO group, respectively.


Conclusion: Our limited experience showed that the intravitreal injection of Stivant® was well tolerated. Although the results of this case series showed relative improvement in CMT one month after the last injection of Stivant®, BCVA improvement was statistically significant only in the RVO group. This would be essential to design a randomized clinical trial to evaluate the non-inferiority of Stivant® in comparison to bevacizumab.

Keywords:

Stivant®, Bevacizumab, Anti-VEGFs, Anti-vascular Endothelial Growth Factors, Diabetic Macular Edema, Retinal Vein Occlusion (RVO), Neovascular Age-related Macular Degeneration (nAMD)

References
1. Ferrara N, Adamis AP. Ten years of anti-vascular endothelial growth factor therapy. Nat Rev Drug Discov 2016;15:385.

2. Berg K, Pedersen TR, Sandvik L, Bragadóttir R. Comparison of ranibizumab and bevacizumab for neovascular age-related macular degeneration according to LUCAS treat-and-extend protocol. Ophthalmology 2015;122:146–152.

3. Chakravarthy U, Harding SP, Rogers CA, Downes SM, Lotery AJ, Culliford LA, et al. et al. Alternative treatments to inhibit VEGF in age-related choroidal neovascularisation: 2-year findings of the IVAN randomised controlled trial. The Lancet 2013;382:1258–1267.

4. Ehlers JP. The MANTA 1-year results: the anti-VEGF debate continues. BMJ Publishing Group Ltd; 2013.

5. Group CR. Ranibizumab and bevacizumab for neovascular age-related macular degeneration. N Engl J Med 2011;364:1897–1908.

6. Kodjikian L, Souied EH, Mimoun G, Decullier E, Huot L, Aulagner G. Ranibizumab versus bevacizumab for neovascular age-related macular degeneration: results from the GEFAL noninferiority randomized trial. Ophthalmology 2013;120:2300–2309.

7. Parikh R, Ross JS, Sangaralingham LR, Adelman RA, Shah ND, Barkmeier AJ. Trends of anti-vascular endothelial growth factor use in ophthalmology among privately insured and Medicare advantage patients. Ophthalmology 2017;124:352–358.

8. Lashay A, Faghihi H, Mirshahi A, Khojasteh H, Khodabande A, Riazi-Esfahani H, et al, et al. Safety of intravitreal injection of Stivant®, a biosimilar to bevacizumab, in rabbit eyes. J Ophthalmic Vis Res 2020;15:341–350.

9. Scavone C, Rafaniello C, Berrino L, Rossi F, Capuano A. Strengths, weaknesses and future challenges of biosimilars’ development. An opinion on how to improve the knowledge and use of biosimilars in clinical practice. Pharmacol Res 2017;126:138–142.

10. Sharma A, Kumar N, Kuppermann BD, Bandello F, Loewenstein A. Understanding biosimilars and its regulatory aspects across the globe: an ophthalmology perspective. Br J Ophthalmol 2019;104:2–7.

11. Sharma A, Reddy P, Kuppermann BD, Bandello F, Lowenstein A. Biosimilars in ophthalmology: “is there a big change on the horizon?” Clin Ophthalmol 2018;12:2137.

12. Zarbin M. The development pathway for biosimilar biotherapeutics. J Ophthalmic Vis Res 2020;15:273–274.

13. Sameera V, Apoorva A, Joshi S, Guruprasad A. Safety and efficacy of Razumab–the new biosimilar in India: our experience. Kerala J Ophthalmol 2016;28:180.

14. Sharma S, Khan MA, Chaturvedi A. Real-life clinical effectiveness of Razumab® (the world’s first biosimilar of Ranibizumab) in retinal vein occlusion: a subgroup analysis of the pooled retrospective RE-ENACT study. Ophthalmologica 2019;241:24–31.

15. Warudkar S. Retrospective efficacy and safety analysis of zybev (biosimilar of bevacizumab) use at tertiary eye care centres in India: spectra trial. Int J Adv Res 2018;6:406– 410.