Background and objective: This study evaluated treatment patterns and outcomes among patients with diabetic macular edema (DME) treated with the bispecific antibody faricimab in routine clinical practice in the United States.
Patients and methods: FARETINA-DME was a retrospective study among patients with DME initiating faricimab from February 2022 to June 2023 identified from the United States IRIS® Registry.
Results: Four thousand five hundred fourteen (4,514) patients (6,204 eyes) previously treated with anti-vascular endothelial growth factor (anti-VEGF) therapy and 691 treatment-naïve patients (851 eyes) were included. In previously treated eyes, mean ± SD visual acuity was 64.0 ± 18.3 letters at index and 65.3 ± 19.0 at faricimab injection 4. In treatment-naïve eyes, visual acuity improved from 60.3 ± 19.8 to 63.9 ± 18.5 letters (P < 0.01). Mean ± SD central subfield thickness improved from 364.3 ± 132.2 to 330.1 ± 121.2 μm in previously treated eyes and 359.6 ± 115.0 to 307.4 ± 114.6 μm in treatment-naïve eyes (both P < 0.01).
Conclusions: In patients with DME receiving faricimab, visual acuity was maintained in previously treated and improved in treatment-naïve eyes. Both groups had anatomical improvement.