Loading dose and 12-month outcomes in treatment-naïve patients with neovascular age-related macular degeneration treated with faricimab, with AI-based analysis of fluid dynamics.

PURPOSE: To evaluate the effects of loading dose and 12 months of faricimab treatment on visual function, retinal anatomy, and fluid dynamics in a real-world cohort of treatment-naïve patients with neovascular age-related macular degeneration (nAMD). METHODS: Patients received intravitreal faricimab 6 mg monthly (to Month 4) followed by personalized treat-and-extend regimens allowing 4-week interval adjustments. Best-corrected visual acuity (BCVA), retinal anatomy, and fluid dynamics (evaluated using an artificial intelligence-based automated fluid quantification system) were assessed monthly to Month 4, then at Months 6, 9, and 12. RESULTS: Fifty-one patients (57 study eyes; mean [SD] BCVA: 66.5 [13.4] letters; mean [SD] central retinal thickness [CRT]: 340.7 [84.7] μm at baseline) were enrolled. Significant improvements in mean BCVA (+ 3.3 letters; P < 0.001) and CRT (- 70.5 μm; P < 0.001) were observed by Month 4. Maximal pigment epithelium detachment (PED) height reduced significantly from baseline to Month 4. Improvements were maintained to Month 12. Intra- and subretinal fluid and PED volumes were significantly reduced versus baseline at all time points. At Month 12, 73.3% of patients were on treatment intervals of 12 weeks or longer. Three adverse events were observed, including one mild intraocular inflammation. CONCLUSION: Treatment with faricimab resulted in rapid and sustained functional and anatomical improvements in treatment-naïve nAMD.