Faricimab rapidly improves fluid parameters in patients with nAMD

Abstract

Purpose : Year 2 data from the phase 3 TENAYA/LUCERNE (NCT03823287/NCT03823300) trials demonstrated that faricimab, a dual angiopoietin-2 (Ang-2)/vascular endothelial growth factor-A (VEGF-A) inhibitor, maintained vision with extended treatment durability and fewer injections versus aflibercept in patients with neovascular age-related macular degeneration (nAMD). The purpose of this analysis was to evaluate fluid outcomes, including the time to first absence of fluid in TENAYA/LUCERNE.

Methods : TENAYA/LUCERNE were double-masked, active comparator–controlled, 112-week trials. Trial details have been presented before. In brief, treatment-naïve patients (pooled N = 1329) were randomized 1:1 to faricimab 6.0 mg up to every 16 weeks (Q16W; n = 665) based on protocol-defined disease activity criteria, with fixed up to Q16W dosing in the first year and a treat-and-extend regimen (personalized treatment interval per protocol) in the second, or aflibercept 2.0 mg Q8W (n = 664). In this post hoc analysis, change in central subfield thickness (CST), absence of subretinal and intraretinal fluid (SRF and IRF), and time to absence of SRF and IRF were assessed in the faricimab versus aflibercept arms during the initial matched-dosing period (weeks 0–12).

Results : During the matched-dosing period, faricimab resulted in a significantly greater reduction in CST from baseline versus aflibercept (week 12: –145 vs –133 µm; P ≤ 0.0001; Fig 1). Likewise, a significantly larger proportion of patients achieved absence of SRF and IRF with faricimab versus aflibercept (week 12: 77% vs 67%; P ≤ 0.0001; Fig 1). In patients with SRF and IRF at baseline, absence of IRF and SRF was achieved faster and with fewer injections with faricimab versus aflibercept (75th percentile of the time to first absence of IRF and SRF was week 8 with faricimab versus week 12 with aflibercept; corresponding median number of injections: 2 vs 3).

Conclusions : Dual inhibition of Ang-2 and VEGF-A with faricimab resulted in more rapid improvement in anatomical outcomes, including absence of fluid, in patients with nAMD during the matched-dosing period in TENAYA/LUCERNE.

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