The Real-World Efficacy and Safety of Faricimab in Neovascular Age-Related Macular Degeneration: The TRUCKEE Study

Abstract

Purpose : Faricimab was FDA-approved for neovascular age-related macular degeneration (nAMD) in Jan 2022. This multi-center, prospective study evaluates the safety and efficacy of faricimab in real-world patients diagnosed with nAMD.

Methods : This study investigates both treatment-naïve patients and patients switched to faricimab from other anti-VEGF agents. Data collected includes demographics, treatment history, best-corrected visual acuity (BCVA), central subfield thickness (CST), and presence of subretinal or intraretinal fluid (SRF or IRF). Snellen visual acuity was converted to Early Treatment Diabetic Retinopathy Study (ETDRS) scoring. Improvements in visual acuity and CST are evaluated as averages. Improvements in retinal fluid are evaluated as a proportion. Observed and calculated data is reported. Safety is summarized.

Results : A total of 670 eyes across 584 patients were recorded. The average age was 80.3 years and 57.3% were female. Of the 475 eyes with follow-up, 60.4% had switched from aflibercept. All eyes post one injection of faricimab (n=475) had a BCVA increase of +0.98 letters (p=0.025), a CST decrease of -30.99mm (p<0.00001), and SRF/IRF resolution rates of 33.6% and 15.1%. Eyes switched from aflibercept post one injection of faricimab (n=287) had a BCVA increase of +0.36 letters (p=0.75), a CST decrease of -25.73mm (p<0.00001), and SRF/IRF resolution rates 32.0% and 9.4%. All eyes post three injections of faricimab (n=213) had a BCVA increase of +3.17 letters (p=0.001), a CST decrease of -45.04mm (p<0.00001), and SRF/IRF resolution rates of 38.1% and 31.1%. Eyes switched from aflibercept post three injections of faricimab (n=140) had a BCVA increase of +2.89 letters (p=0.008), a CST decrease of -40.74mm (p=0.00007), and SRF/IRF resolution rates of 37.3% and 15.7%. Of 1,882 injections, no cases of faricimab-related vasculitis or retinal artery occlusion have been reported.

Conclusions : Faricimab has demonstrated efficacy via anatomic and visual parameters, in both treatment-naïve and previously treated patients, a demographic not studied in the trials leading to FDA-approval. Safety is comparable to current agents, with multiple adverse events attributable to non-drug related processes. Future results will continue to investigate the safety and efficacy of faricimab in real-world patients suffering from nAMD. Latest data will be presented at ARVO 2023.

This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.