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.