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Introduction <p>Reducing intravitreal injection frequency while maintaining efficacy is a critical goal in alleviating the burden associated with anti-vascular endothelial growth factor (VEGF) therapy in patients with diabetic macular edema (DME) or neovascular age-related macular degeneration (nAMD). In clinical trials, aflibercept 8 mg and faricimab 6 mg administered at extended dosing intervals have demonstrated similar efficacy compared with aflibercept 2 mg, but with fewer injections. This network meta-analysis (NMA) indirectly compared numbers of injections and efficacy between aflibercept 8 mg and faricimab 6 mg administered according to a treat-and-extend (T&amp;E)-based regimen in patients with DME or nAMD.</p> Methods <p>A systematic literature review was conducted on 10 January 2025, to identify randomized controlled trials of aflibercept 8 mg or faricimab T&amp;E with observation periods of approximately 2 years. Outcomes included number of injections, absolute change from baseline in best-corrected visual acuity (BCVA), and absolute and percentage change from baseline in central subfield thickness (CST). NMAs were performed with Bayesian statistical models. Injection numbers were adjusted to 104 weeks to account for differences in trial observation periods.</p> Results <p>The NMA included 2-year data from six trials: PHOTON, YOSEMITE, and RHINE (DME); and PULSAR, TENAYA, and LUCERNE (nAMD). Treatment with aflibercept 8 mg was associated with significantly fewer injections compared with faricimab T&amp;E in patients with DME (mean difference −3.62 [95% credible interval −4.22, −3.02]) or nAMD (−1.47 [−1.90, −1.05]). Mean changes from baseline in BCVA (absolute) or CST (absolute and percentage) did not differ significantly between the two treatments.</p> Conclusion <p>This NMA indicated that aflibercept 8 mg required significantly fewer injections while maintaining similar efficacy over 2 years of treatment compared with faricimab T&amp;E in patients with DME or nAMD.</p>

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Aflibercept 8 mg versus Faricimab Treat-and-Extend for Diabetic Macular Edema or Neovascular Age-Related Macular Degeneration: A Bayesian Fixed-Effect Network Meta-analysis of Clinical Trials

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年9月25日

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  • Scott M. Friedman,
  • Yingxin Xu,
  • Steven Sherman,
  • Andreas Kuznik,
  • Ali Mojebi,
  • Sam Keeping,
  • Keith Chan,
  • Theodore Leng,
  • Nimesh Patel

摘要

Introduction

Reducing intravitreal injection frequency while maintaining efficacy is a critical goal in alleviating the burden associated with anti-vascular endothelial growth factor (VEGF) therapy in patients with diabetic macular edema (DME) or neovascular age-related macular degeneration (nAMD). In clinical trials, aflibercept 8 mg and faricimab 6 mg administered at extended dosing intervals have demonstrated similar efficacy compared with aflibercept 2 mg, but with fewer injections. This network meta-analysis (NMA) indirectly compared numbers of injections and efficacy between aflibercept 8 mg and faricimab 6 mg administered according to a treat-and-extend (T&E)-based regimen in patients with DME or nAMD.

Methods

A systematic literature review was conducted on 10 January 2025, to identify randomized controlled trials of aflibercept 8 mg or faricimab T&E with observation periods of approximately 2 years. Outcomes included number of injections, absolute change from baseline in best-corrected visual acuity (BCVA), and absolute and percentage change from baseline in central subfield thickness (CST). NMAs were performed with Bayesian statistical models. Injection numbers were adjusted to 104 weeks to account for differences in trial observation periods.

Results

The NMA included 2-year data from six trials: PHOTON, YOSEMITE, and RHINE (DME); and PULSAR, TENAYA, and LUCERNE (nAMD). Treatment with aflibercept 8 mg was associated with significantly fewer injections compared with faricimab T&E in patients with DME (mean difference −3.62 [95% credible interval −4.22, −3.02]) or nAMD (−1.47 [−1.90, −1.05]). Mean changes from baseline in BCVA (absolute) or CST (absolute and percentage) did not differ significantly between the two treatments.

Conclusion

This NMA indicated that aflibercept 8 mg required significantly fewer injections while maintaining similar efficacy over 2 years of treatment compared with faricimab T&E in patients with DME or nAMD.