Background <p>Faricimab, a monoclonal bispecific antibody, has recently been incorporated into clinical practice in China. This study main to evaluate the efficacy and safety of intravitreal faricimab in patients with previously treated nAMD and DME under real-world clinical conditions, and to investigate potential associations.</p> Methods <p>In this study, patients with nAMD or DME previously treated with other anti-VEGF (Anti-vascular endothelial growth factor) agents or Ozurdex received faricimab. Changes in best-corrected visual acuity (BCVA), central subfield thickness (CST), and central subfield maximum thickness (CSMT) were assessed. For nAMD, choroidal neovascularization cross-sectional area (CSA) was measured. Optical coherence tomography (OCT) biomarkers were analyzed, and their correlation with BCVA was examined using Spearman analysis.</p> Results <p>At week 16, BCVA improved from 0.92 to 0.76 logMAR in nAMD and from 0.86 to 0.68 logMAR in DME. CST and CSMT significantly decreased from week 4 to 16 (CST: 539.38 to 408.50&#xa0;μm in nAMD, 502.81 to 292.64&#xa0;μm in DME; CSMT: 710.18 to 526.79&#xa0;μm in nAMD, 586.96 to 356.82&#xa0;μm in DME). CSA reduced from 9.06 to 7.26&#xa0;mm². BCVA positively correlated with subretinal fluid in nAMD and with external limiting membrane/ellipsoid zone integrity in DME, but negatively with subretinal hyperreflective material. No serious adverse events occurred. No serious adverse events were observed.</p> Conclusions <p>In a real-world setting, intravitreal faricimab demonstrated a favorable safety profile and robust anatomical response in treating treatment-experienced nAMD and DME. However, the anatomical response was stronger than the visual gain in these treatment-experienced eyes, which often have limited visual potential.</p> Trial registration <p>This study was a Retrospective observational study that approved by the Second Affiliated Hospital of Chongqing Medical University(2025IIT904).</p>

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A real-world study of Faricimab: efficacy and biomarkers in treatment-experienced neovascular age-related macular degeneration(nAMD) and diabetic macular edema (DME) patients

  • Ruimin Fan,
  • Danning Liu

摘要

Background

Faricimab, a monoclonal bispecific antibody, has recently been incorporated into clinical practice in China. This study main to evaluate the efficacy and safety of intravitreal faricimab in patients with previously treated nAMD and DME under real-world clinical conditions, and to investigate potential associations.

Methods

In this study, patients with nAMD or DME previously treated with other anti-VEGF (Anti-vascular endothelial growth factor) agents or Ozurdex received faricimab. Changes in best-corrected visual acuity (BCVA), central subfield thickness (CST), and central subfield maximum thickness (CSMT) were assessed. For nAMD, choroidal neovascularization cross-sectional area (CSA) was measured. Optical coherence tomography (OCT) biomarkers were analyzed, and their correlation with BCVA was examined using Spearman analysis.

Results

At week 16, BCVA improved from 0.92 to 0.76 logMAR in nAMD and from 0.86 to 0.68 logMAR in DME. CST and CSMT significantly decreased from week 4 to 16 (CST: 539.38 to 408.50 μm in nAMD, 502.81 to 292.64 μm in DME; CSMT: 710.18 to 526.79 μm in nAMD, 586.96 to 356.82 μm in DME). CSA reduced from 9.06 to 7.26 mm². BCVA positively correlated with subretinal fluid in nAMD and with external limiting membrane/ellipsoid zone integrity in DME, but negatively with subretinal hyperreflective material. No serious adverse events occurred. No serious adverse events were observed.

Conclusions

In a real-world setting, intravitreal faricimab demonstrated a favorable safety profile and robust anatomical response in treating treatment-experienced nAMD and DME. However, the anatomical response was stronger than the visual gain in these treatment-experienced eyes, which often have limited visual potential.

Trial registration

This study was a Retrospective observational study that approved by the Second Affiliated Hospital of Chongqing Medical University(2025IIT904).