The Real-World Efficacy and Safety of Faricimab in Neovascular Age-Related Macular Degeneration: The TRUCKEE Study - 2 Year Results

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 included 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 2622 eyes across 2212 patients were recorded. The average age was 80.1 years, 57.0% were female and 46.6% had switched from aflibercept. All eyes switched from any anti-VEGF post one injection of faricimab (n=2250) had a BCVA increase of +0.54 letters (p=0.353), a CST decrease of -24.76um (p<0.00001), and SRF/IRF resolution rates of 29.8% and 25.5%. Eyes switched from aflibercept post one injection of faricimab (n=1007) had a BCVA increase of +0.48 letters (p=0.54), a CST decrease of -21.03um (p<0.0004), and SRF/IRF resolution rates 29.3% and 24.1%. All eyes switched from any anti-VEGF post six injections of faricimab (n=397) had a BCVA increase of +0.47 letters (p=0.55), a CST decrease of -24.08um (p<0.0003), and SRF/IRF resolution rates of 26.3% and 11.7%. Eyes switched from aflibercept post six injections of faricimab (n=219) had a BCVA decrease of -0.78 letters (p=0.62), a CST decrease of -48.98um (p=0.0018), and SRF/IRF resolution rates 35.4% and 34.1%. Intraocular inflammation was noted at a rate of 0.02% per injection.

Conclusions : Faricimab has demonstrated efficacy via anatomic and visual parameters, in previously treated patients, a demographic not studied in the trials leading to FDA-approval. Safety is comparable to current agents, with multiple cases attributable to non-drug related processes. Future results will continue to investigate the long term safety, efficacy and durability of faricimab in real-world patients with nAMD. First time two-year data will be presented at ARVO 2024.

This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.