In recent findings from the TENAYA and LUCERNE phase 3 clinical trials, faricimab showed faster resolution of retinal fluid and greater reductions in central subfield thickness during the 12-week head-to-head dosing phase, compared with aflibercept in patients with neovascular age-related macular degeneration.

TENAYA and LUCERNE were randomized, double-masked, comparator-controlled trials with 1,329 patients aged 50 years and over with treatment-naïve neovascular age-related macular degeneration (nAMD). According to the recent data published in Ophthalmology, patients were randomized 1:1 to receive faricimab 6.0 mg every 16 weeks after initial monthly doses or aflibercept 2.0 mg every 8 weeks after initial monthly doses. Central subfield thickness (CST) reduction, resolution of intraretinal fluid (IRF) and subretinal fluid (SRF), and time to first absence of IRF and SRF were analyzed. 

Faricimab achieved significantly greater CST reductions than aflibercept. At week 4, adjusted mean reduction in CST was -128.8 µm vs. -115.0 µm with aflibercept. At week 8, the mean reduction with faricimab was -140.3 µm compared with -127.7 µm for aflibercept. At week 12, the mean reduction was -145.4 µm vs. -133.0 µm with aflibercept. Also at week 12, 87.9% of patients treated with faricimab achieved absence of SRF vs. 79.0% of patients treated with aflibercept, and 77.2% of faricimab patients achieved absence of both IRF and SRF, compared to 66.5% of patients on aflibercept. Throughout the study, the proportions of patients with absence of IRF was comparable for both drugs.

Faricimab also achieved the first absence of IRF and SRF faster than aflibercept. Median time to fluid resolution was 4 weeks with faricimab and 8 weeks with aflibercept. 

At week 12, faricimab and aflibercept achieved comparable improvements in best-corrected visual acuity: +6.7 letters (faricimab) vs. +5.9 letters (aflibercept). Both drugs exhibited similar safety profiles, with no significant differences in adverse events. Comparisons beyond 12 weeks were not feasible due to differences in treatment regimens.

The researchers hypothesized, "the early disease control observed with faricimab treatment is driven by the vascular stabilizing effects of Ang-2 inhibition beyond anti-VEGF-A alone,” a suggestion that is supported by preclinical studies, the phase 2 CANDELA trial, and the HARBOR trial. Faster fluid resolution may enable earlier extension of treatment intervals, they described, reducing patient burden and healthcare costs due to the lower number of faricimab injections that may be necessary to achieve and maintain disease control.

A full list of author disclosures can be found in the published research