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Background <p>Faricimab is a bispecific monoclonal antibody targeting both vascular endothelial growth factor A and angiopoietin-2, approved for macular oedema secondary to retinal vein occlusion in 2023. The phase III BALATON and COMINO trials demonstrated non-inferiority to aflibercept at week 24, and several real-world cohorts have subsequently emerged. The aim of this systematic review and meta-analysis was to estimate the pooled effect of faricimab on visual acuity, treatment burden, anatomical outcomes, and safety in this indication.</p> Methods <p>PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials were systematically searched from inception to 1 May 2026 for studies reporting outcomes following intravitreal faricimab. Risk of bias was assessed in duplicate using the Cochrane Risk of Bias 2 tool for the randomised evidence and the Risk Of Bias In Non-randomised Studies of Interventions tool for the observational evidence, with single-arm cohorts evaluated as pre-post comparisons. The primary visual acuity outcome was pooled using random-effects meta-analysis with Hartung-Knapp-Sidik-Jonkman adjustment, stratified by treatment status, while outcomes precluded from pooling by methodological heterogeneity were synthesised narratively. Certainty of evidence was assessed using the Grading of Recommendations, Assessment, Development and Evaluation framework.</p> Results <p>Ten studies comprising 1,620 eyes met eligibility criteria, including the BALATON and COMINO randomised controlled trials and nine non-randomised cohorts. The pooled mean change in best-corrected visual acuity at approximately 6 months was + 16.89 Early Treatment Diabetic Retinopathy Study letters (95% confidence interval 16.05 to 17.72) in treatment-naïve eyes and + 8.73 letters (95% confidence interval 4.75 to 12.71) in refractory switch cohorts, with negligible between-study heterogeneity in both analyses. Narrative synthesis was consistent with treatment interval extension following initiation of or switch to faricimab, statistically significant reductions in central retinal thickness across studies, and a short-term safety profile without identified retinal vasculitis events.</p> Conclusion <p>The synthesis is consistent with intravitreal faricimab use being associated with visual and anatomical improvement in macular oedema secondary to retinal vein occlusion, with the treatment-naïve pooled estimate primarily reflecting registration trial data and the switch cohort estimate characterising refractory phenotypes.</p>

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Effectiveness and safety of intravitreal faricimab for macular oedema secondary to retinal vein occlusion: a systematic review and meta-analysis

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年7月9日

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  • Ali Alseneid,
  • Shivam Bhindi,
  • Mohammad Saleki,
  • Diya Baker

摘要

Background

Faricimab is a bispecific monoclonal antibody targeting both vascular endothelial growth factor A and angiopoietin-2, approved for macular oedema secondary to retinal vein occlusion in 2023. The phase III BALATON and COMINO trials demonstrated non-inferiority to aflibercept at week 24, and several real-world cohorts have subsequently emerged. The aim of this systematic review and meta-analysis was to estimate the pooled effect of faricimab on visual acuity, treatment burden, anatomical outcomes, and safety in this indication.

Methods

PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials were systematically searched from inception to 1 May 2026 for studies reporting outcomes following intravitreal faricimab. Risk of bias was assessed in duplicate using the Cochrane Risk of Bias 2 tool for the randomised evidence and the Risk Of Bias In Non-randomised Studies of Interventions tool for the observational evidence, with single-arm cohorts evaluated as pre-post comparisons. The primary visual acuity outcome was pooled using random-effects meta-analysis with Hartung-Knapp-Sidik-Jonkman adjustment, stratified by treatment status, while outcomes precluded from pooling by methodological heterogeneity were synthesised narratively. Certainty of evidence was assessed using the Grading of Recommendations, Assessment, Development and Evaluation framework.

Results

Ten studies comprising 1,620 eyes met eligibility criteria, including the BALATON and COMINO randomised controlled trials and nine non-randomised cohorts. The pooled mean change in best-corrected visual acuity at approximately 6 months was + 16.89 Early Treatment Diabetic Retinopathy Study letters (95% confidence interval 16.05 to 17.72) in treatment-naïve eyes and + 8.73 letters (95% confidence interval 4.75 to 12.71) in refractory switch cohorts, with negligible between-study heterogeneity in both analyses. Narrative synthesis was consistent with treatment interval extension following initiation of or switch to faricimab, statistically significant reductions in central retinal thickness across studies, and a short-term safety profile without identified retinal vasculitis events.

Conclusion

The synthesis is consistent with intravitreal faricimab use being associated with visual and anatomical improvement in macular oedema secondary to retinal vein occlusion, with the treatment-naïve pooled estimate primarily reflecting registration trial data and the switch cohort estimate characterising refractory phenotypes.