First-year real-world outcomes of faricimab in clinically significant diabetic macular oedema: a Swiss retina research network report

Aims: Evaluate the efficacy and safety of faricimab for treatment-naïve and pre-treated diabetic macular oedema (DME) in a real-world setting. Methods: This multicentre, retrospective cohort study examined consecutive DME patients treated with faricimab for ≥1 year. Data were collected at predefined time points. Primary outcomes were mean changes in corrected visual acuity (VA), centre-point retinal thickness (CRT) and central subfield thickness (CST) and treatment intervals and adverse events (AEs). Results: 184 eyes with DME were included: 61 (33.2%) were treatment-naïve, and 123 (66.8%) were pretreated. In treatment-naïve eyes, VA improved from 69.7±15 Early Treatment of Diabetic Retinopathy Study letters at baseline to 73.9±14.1 after 12 months (p=0.014), while it remained stable in pretreated eyes (71.2±14.2 vs 73.0±12.9; p=0.14). CST decreased significantly in both groups (treatment-naïve (366.1±108.3 µm to 316.4±113.5 µm, p<0.001); pretreated (339.1±93.1 µm to 298.3±65.8 µm, p<0.001)). Thirty-one percent of naïve eyes and 21.1% of pretreated eyes were completely dry after 12 months. In treatment-naïve eyes, the mean treatment interval was 12.7±6.4 weeks at 12 months. In pretreated eyes, the interval increased from 6.0±3.0 to 7.8±3.6 weeks (p<0.001). Over 12 months, 8.1±2.1 and 9.4±2.5 injections were administered to naïve and pretreated eyes, respectively (p<0.001). Of the five recorded AEs, two cases of non-infectious intraocular inflammation and one cerebrovascular event were reported. Conclusion: Over 12 months, faricimab demonstrated good efficacy and safety in both treatment-naïve and pretreated eyes with DME. There was a reduction in CST and improved VA in treatment-naïve eyes and stable VA in pretreated eyes. The low number of AEs supports a favourable risk-benefit profile of faricimab in a real-world setting.