Twelve months Real-World Outcomes of Faricimab in Treatment-Naïve versus Previously Treated Patients with Neovascular Age-Related Macular Degeneration and Diabetic Macular Edema: visual outcome and macular morphological changes

Abstract Objective To compare the real-world functional and anatomical outcomes of intravitreal Faricimab in treatment-naïve versus previously treated eyes with neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME). Subjects and Methods This prospective, single-center, interventional study recruited 97 eyes of 97 patients with nAMD or DME. All eyes received three consecutive monthly loading doses of Faricimab, followed by an individualized treatment regimen. The primary outcomes were changes in BCVA and CRT from baseline to 6 and 12 months. Results At 6 and 12 months, all groups demonstrated significant improvements in BCVA and CRT from baseline. In nAMD, treatment-naïve patients demonstrated significantly superior functional (+ 28.8 vs. +21.9 ETDRS, P = 0.003) and anatomical outcomes (-268.2 vs. -143.3 µm, P = 0.008) compared to switchers at 12 months. In DME, naïve and switcher patients showed comparable improvements in BCVA (+ 23.4 vs + 20.7 ETDRS letters; P = 0.045) and CRT reduction (− 216.2 vs − 207.7 µm; P = 0.107) at 12 months. Dry retina at 12 months was achieved in 76.6% of naïve nAMD, 66.7% of previously treated nAMD, 85.7% of naïve DME, and 77.3% of previously treated DME eyes. The mean number of injections at 12 months was lower in naïve nAMD and DME patients (7.4 and 6.7 respectively) compared to switchers (8.8 and 8.4 respectively). Conclusion Real-world findings support Faricimab as an effective and well-tolerated treatment for both nAMD and DME, including eyes with previous anti-VEGF treatment, while suggesting greater durability in treatment-naïve eyes. Faricimab demonstrates robust efficacy and achieved high rates of fluid resolution with fewer number of injections.