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An analysis of the TENAYA/LUCERNE presented at ARVO 2023 suggests faricimab more rapidly improved anatomic outcomes in patients with nAMD compared to aflibercept.
A post-hoc analysis of pooled data from the head-to-head dosing period of the phase 3 TENAYA and LUCERNE studies revealed faricimab (Vabysmo) rapidly reduced retinal fluid from baseline compared to aflibercept in patients with neovascular age-related macular degeneration (nAMD).
At the 12-week mark, the analysis showed central subfield thickness (CST) reductions were 145 µm in the faricimab arm and 133 µm in the aflibercept arm. The research was presented at the 2023 Association for Research in Vision and Ophthalmology (ARVO) 2023 Annual Meeting in New Orleans, Louisiana.
“It's an exciting study, what we found that Vabysmo led to greater retinal drying in the head-to-head dosing phase and faster drying with fewer injections compared to aflibercept,” Jeff Willis, MD, PhD, Global Development Leader, Ophthalmology, Genentech told HCPLive at ARVO 2023.
Two-year data from the TENAYA and LUCERNE trials showed that dual inhibition of angiopoetin-2 (Ang-2) and vascular endothelial growth factor-A with faricimab maintained vision with extended durability and fewer injections compared to aflibercept in patients with nAMD. The current analysis evaluated fluid outcomes, including the time to first absence of fluid, in the TENAYA and LUCERNE trials.
The trials were double-masked, active-comparator-controlled, 112-week trials, in which treatment-naive 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. The trials included fixed up to Q16W dosing and a treat-and-extend regimen in the second year, or aflibercept 2.0 Q8W (n = 664).
For the purpose of this post-hoc analysis, investigators measured the change in central subfield thickness (CST), absence of subretinal and intraretinal fluid (SRF and IRF), and time to absence of SRF and IRF in the faricimab versus aflibercept arms during the initial matched-dosing period (weeks 0 - 12).
As indicated, faricimab resulted in a significantly greater reduction in CST from baseline versus aflibercept (week 12: –145 vs. –133 µm; P ≤.0001). Additionally, a significantly larger proportion of patients receiving faricimab achieved absence of retinal fluid at 12 weeks (77%) versus aflibercept (67%), as measured by SRF and IRF (P ≤.0001).
In those with SRF and IRF at baseline, the analysis found the absence of IRF and SRF was achieved faster and with fewer injections with faricimab versus aflibercept. In 75% of patients in each treatment arm, the absence of fluid occurred at 8 weeks with faricimab versus 12 weeks with aflibercept, with a corresponding fewer number of injections (2 vs. 3).
For more insight into this analysis, watch the full interview with Willis at ARVO 2023 below.
Disclosures: Jeff Willis, MD, PhD is employed by Genentech, Inc.