Anatomic Outcomes with Faricimab vs Aflibercept in Head-to-Head Dosing Phase of the TENAYA/LUCERNE Trials in Neovascular Age-related Macular Degeneration

Abstract

Purpose: To compare early anatomic outcomes after treatment with faricimab versus aflibercept in a pooled analysis of the head-to-head dosing phase of the TENAYA/LUCERNE trials in neovascular age-related macular degeneration (nAMD).

Design: TENAYA/LUCERNE (NCT03823287/NCT03823300) were identical, randomized, double-masked, active comparator-controlled phase 3 noninferiority trials.

Participants: Patients aged ≥ 50 years with treatment-naïve nAMD.

Methods: Patients were randomized (1:1) to intravitreal faricimab 6.0 mg up to every 16 weeks (Q16W) after 4 initial doses every 4 weeks (Q4W) or aflibercept 2.0 mg every 8 weeks (Q8W) after 3 initial doses given Q4W.

Main outcome measures: Post hoc analyses comparing faricimab with aflibercept in terms of change in central subfield thickness (CST) from baseline and proportion of patients with an absence of subretinal fluid (SRF) and intraretinal fluid (IRF) during initial 12-week head-to-head dosing phase, when both arms received 3 injections, and time to first absence of IRF and SRF.

Results: A total of 1329 patients were enrolled across TENAYA/LUCERNE (n = 665 faricimab; n = 664 aflibercept). There were greater (nominal P < 0.0001) reductions in adjusted mean CST from baseline with faricimab versus aflibercept at weeks 4, 8, and 12, with comparable vision outcomes. At week 12, more patients (95% confidence interval) achieved an absence of SRF (87.9% [85.4%-90.4%] vs. 79.0% [76.0%-82.1%]) and both IRF and SRF (77.2% [74.0%-80.4%] vs. 66.5% [62.9%-70.0%]) but not IRF (88.4% [86.0%-90.8%] vs. 85.0% [82.3%-87.6%]), with faricimab versus aflibercept, respectively. In patients with IRF or SRF at baseline (n = 581 faricimab; n = 591 aflibercept), the 75th percentile of time to first absence of IRF and SRF was reached at week 8 with faricimab and week 12 with aflibercept. At week 12, cumulative incidence of first-time absence of IRF and SRF was 85.5% (82.3%-88.1%) with faricimab and 75.0% (71.3%-78.3%) with aflibercept.

Conclusions: Faricimab resulted in greater improvement in anatomic outcomes than aflibercept during the head-to-head dosing phase and a faster time to first absence of retinal fluid.

Financial disclosure(s): Proprietary or commercial disclosure may be found after the references.

Keywords: Anatomic control; Angiopoietin-2 (Ang-2); Faricimab; Neovascular age-related macular degeneration; VEGF-A.