Real-Life Comparison of Off-Label Intravitreal Biosimilar Bevacizumab-awwb and Reference Bevacizumab in Treatment-Naïve Patients with Neovascular Age-Related Macular Degeneration, Diabetic Macular Edema, and Retinal Vein Occlusion

Mehmet Orkun Sevik; Simge Gizem Koyu; Aslan Aykut; Didem Dizdar Yiğit; Özlem Şahin

doi:10.31067/acusaglik.1528212

EN

Real-Life Comparison of Off-Label Intravitreal Biosimilar Bevacizumab-awwb and Reference Bevacizumab in Treatment-Naïve Patients with Neovascular Age-Related Macular Degeneration, Diabetic Macular Edema, and Retinal Vein Occlusion

Abstract

Purpose: To compare the functional, anatomical, and safety results of intravitreal biosimilar bevacizumab-awwb (IVB-awwb; Mvasi®) and reference bevacizumab (IVB; Altuzan®) in patients with neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), and macular edema secondary to retinal vein occlusion (RVO). Methods: This non-randomized, retrospective, real-life study included 191 treatment-naïve eyes (62 nAMD, 96 DME, and 33 RVO) of 150 patients receiving three monthly IVB and IVB-awwb loading doses. Baseline and final (one month after the third injection) best-corrected visual acuity (BCVA; logMAR) and central macular thickness (CMT; µm) of the eyes with nAMD, DME, and RVO, disease activity rates for nAMD, and overall endophthalmitis rates were compared between IVB and IVB-awwb groups. Results: The mean baseline and final BCVA and CMT were comparable for nAMD (32 vs. 30 eyes), DME (47 vs. 49 eyes), and RVO (14 vs. 19 eyes) in IVB and IVB-awwb groups. The final nAMD activity rates were 53.1% and 63.3% in the groups, respectively (p=0.578). In DME eyes, BCVA significantly improved in the IVB group (p=0.002) with no significant difference in the IVB-awwb group (p=0.152), and the mean change in BCVA was -0.180.38 and -0.090.45 logMAR, respectively (p=0.033). Culture-negative endophthalmitis (n=2; 2.0% overall) was observed only in the IVB-awwb group (p=0.498). Conclusion: This real-life study suggests that intravitreal biosimilar bevacizumab-awwb could yield comparable or worse but no better results than reference bevacizumab in eyes with nAMD, DME, and macular edema secondary to RVO. Further randomized studies are required to elucidate the efficacy and safety of IVB-awwb.

Keywords

Supporting Institution

Not applicable.

Project Number

Not applicable.

Ethical Statement

The study protocol was approved by the institutional review board of Marmara University School of Medicine, Istanbul, Turkey (No: 09.2023.873, 09.2023.874, and 09.2023.875).

Thanks

Not applicable.

References

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Details

Primary Language

English

Subjects

Ophthalmology

Journal Section

Research Article

Authors

Mehmet Orkun Sevik ^*
0000-0001-7130-4798
Türkiye

Simge Gizem Koyu
0000-0003-2035-1273
Türkiye

Aslan Aykut
0000-0001-5426-1992
Türkiye

Didem Dizdar Yiğit
0000-0001-7309-3293
Türkiye

Özlem Şahin
0000-0003-2907-2852
Türkiye

Publication Date

July 1, 2025

Submission Date

August 5, 2024

Acceptance Date

January 29, 2025

Published in Issue

Year 2025 Volume: 16 Number: 3

DOI

https://doi.org/10.31067/acusaglik.1528212

IZ

https://izlik.org/JA28RK53SY

Cite

RIS / Bibtex

EndNote

Sevik MO, Koyu SG, Aykut A, Dizdar Yiğit D, Şahin Ö (July 1, 2025) Real-Life Comparison of Off-Label Intravitreal Biosimilar Bevacizumab-awwb and Reference Bevacizumab in Treatment-Naïve Patients with Neovascular Age-Related Macular Degeneration, Diabetic Macular Edema, and Retinal Vein Occlusion. Acıbadem Üniversitesi Sağlık Bilimleri Dergisi 16 3 352–361.