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Turkish Journal of Medical Sciences

Abstract

Background/aim: Bevacizumab biosimilars are increasingly used as alternatives to reference bevacizumab in ophthalmic practice, but comparative real-world evidence in treatment-naïve neovascular age-related macular degeneration (nAMD) remains limited. In this study, the short-term anatomical, functional, and documented safety outcomes associated with bevacizumab, bevacizumab-bvzr (Zirabev), and bevacizumab-awwb (Mvasi) were evaluated in treatment-naïve patients with nAMD in a multicentre real-world setting.

Materials and methods: This multicentre retrospective cohort included 250 treatment-naïve eyes with nAMD from 16 centres in Türkiye that completed a 3-month loading regimen with the same bevacizumab agent. Central macular thickness (CMT) was the prespecified primary longitudinal outcome; best-corrected visual acuity (BCVA) was secondary, while intraretinal fluid (IRF) and subretinal fluid (SRF) were repeated binary outcomes. CMT and BCVA were analysed using longitudinal linear mixed-effects models, whereas IRF and SRF were analysed using binomial generalised linear mixed-effects models with a logit link. Documented adverse events were assessed descriptively.

Results: In the primary longitudinal CMT analysis, time (p < 0.001) and the agent-by-time interaction (p = 0.016) were significant, whereas the overall agent effect was not (p = 0.932). At the third follow-up, adjusted mean CMT was 295.1 (95% CI, 276.5–313.6), 302.4 (277.1–327.8), and 306.2 (281.7–330.7) μm for bevacizumab, bevacizumab-bvzr, and bevacizumab-awwb, respectively. For BCVA, time (p < 0.001), agent (p = 0.042), and the agent-by-time interaction (p = 0.031) were significant; corresponding adjusted mean BCVA values were 0.721 (95% CI, 0.632–0.810), 0.605 (0.483–0.726), and 0.897 (0.779–1.016) logMAR. IRF decreased over time (p = 0.001), without significant agent or interaction effects. Time-averaged adjusted SRF probability was lower with bevacizumab-bvzr than with bevacizumab and bevacizumab-awwb. No systemic adverse events were documented; ocular adverse-event observations were infrequent.

Conclusion: Short-term anatomical and visual outcomes changed during the three-injection loading phase, with adjusted longitudinal trajectories differing for CMT and BCVA. These findings represent exploratory observational associations and do not demonstrate superiority or equivalence among the agents.

Author ORCID Identifier

EYÜPCAN ŞENSOY: 0000-0002-4401-8435

MEHMET ÇITIRIK: 0000-0001-6200-0506

BURHAN BAŞKAN: 0000-0002-2481-9892

HASAN ÖNCÜL: 0000-0003-0513-6065

ABDULLAH BEYOĞLU: 0000-0003-1948-7755

DOI

10.55730/1300-0144.6383

Keywords

Bevacizumab, bevacizumab biosimilars, neovascular age-related macular degeneration, retrospective cohort study, short-term outcomes

First Page

1373

Last Page

1383

Publisher

The Scientific and Technological Research Council of Türkiye (TÜBİTAK)

Creative Commons License

Creative Commons Attribution 4.0 International License
This work is licensed under a Creative Commons Attribution 4.0 International License.

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