Intravitreal faricimab for treatment naïve patients with neovascular age-related macular degeneration: a real-world prospective study

Abstract

Background: Intravitreal faricimab, a bispecific antibody targeting both angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A), was recently introduced for the treatment of neovascular age-related macular degeneration (nAMD), diabetic macular oedema and cystoid macular oedema secondary to retinal vein occlusion. The aim of our study was to assess the efficacy, safety and durability of intravitreal faricimab in a real-world cohort of treatment-naïve patients with nAMD.

Methods: Single-centre, prospective cohort study of 21 eyes from 19 treatment-naïve nAMD patients who were treated with intravitreal faricimab from October 2022 to April 2024. Patients underwent a loading dose (LD) of 4 monthly faricimab injections followed by a treat-and-extend regimen. Primary outcomes included best-corrected visual acuity (BCVA) and structural parameters from spectral-domain optical coherence tomography (SD-OCT). Secondary outcomes included the proportion of eyes achieving a dry macula, maximal fluid-free interval and intended interval at last follow-up.

Results: The study included 21 eyes of 19 patients (mean age 83.1 years). After LD, 93.3% of eyes achieved a dry macular SD-OCT scan within a median time of 8 weeks. At the first extension, 53% of eyes remained dry, while 47% showed fluid recurrence. Long-term analysis (n = 14) revealed significant reductions in macular volume (MV), central subfield thickness (CST), and pigment epithelial detachment (PED) height over a median follow-up of 64.9 weeks, with sustained visual and anatomical improvements. Median BCVA, CST, and MV at the final follow-up were significantly improved from baseline (p < 0.01). The intended interval between injections was ≥ 12 weeks in 42.86% of eyes. No cases of intraocular inflammation were observed, although 10% experienced retinal pigment epithelial tears.

Conclusions: Intravitreal faricimab demonstrated favourable efficacy, safety, and durability outcomes in a real-world cohort of treatment-naïve nAMD patients.

Keywords: Age-related macular degeneration; Anti-angiopoietin 2; Anti-vascular endothelial growth factor; Faricimab; Treat-and-extend.

Fig. 1

A-C. Changes in structural parameters for each study eye (n = 14) between timepoints T0 (baseline), T1 (week 12), T2 (post-first extension), T3 (last visit). Neovascularisation subtypes were identified using different colours (Type 3, blue; polypoidal choroidal vasculopathy, purple; Type 1, green; Type 4, red). A rapid and marked improvement in MV, CST and PED height is noted at T1, with mild changes during the maintenance phase (T1-T3). A. Macular volume (MV). B. Central subfield thickness (CST). C. Pigment epithelial detachment (PED) height

Fig. 2

A-B. a. Heatmap graph showing longitudinal changes in dosing interval trends over 48 weeks. Horizontal lines show trends for each individual case (n = 14) over time, with colder and warmer colours representing shorter or longer dosing intervals, respectively. b. Pie graphs highlighting the proportion of study eyes achieving a longest dry interval (left, green) or achieving an intended interval at last visit (right, blue) ≤ 8-week dosing, between 9 and 11-week dosing or ≥ 12 weeks as per structural spectral-domain macular optical coherence tomography. The proportion of eyes extended or maintained to ≥ 12 weeks at the last clinic visit was 42.86% although only 28.57% of eyes achieved a longest dry interval ≥ 12 weeks, suggesting fluid tolerance in 14.29% of cases

Fig. 3

Variations in median best corrected visual acuity (BCVA) between timepoints T0 (baseline), T1 (week 12), T2 (post-first extension), T3 (last follow-up)