June 2023
Volume 64, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2023
Faricimab rapidly improves fluid parameters in patients with nAMD
Author Affiliations & Notes
  • Giuseppe Querques
    School of Medicine, Vita-Salute San Raffaele University, Milan, Italy
  • Nikolas London
    Retina Consultants San Diego, San Diego, California, United States
  • Aachal Kotecha
    Roche Products Ltd., Welwyn Garden City, United Kingdom
  • Jeffrey Willis
    Genentech Inc, South San Francisco, California, United States
  • Audrey Souverain
    F. Hoffmann-La Roche, Basel, Switzerland
  • Eugene Shildkrot
    Genentech Inc, South San Francisco, California, United States
  • philippe margaron
    F. Hoffmann-La Roche, Basel, Switzerland
  • Footnotes
    Commercial Relationships   Giuseppe Querques Alfa Intes, Alimera Sciences, Inc., Abbvie, Apellis, Baush & Lomb, Bayer Healthcare Pharmaceuticals, Boehringer Ingelheim, CenterVue, Heidelberg Engineering, Lumithera, Novartis Pharmaceuticals, Roche, Thea, Zeiss., Code C (Consultant/Contractor); Nikolas London Amgen, Annexon, Apellis, Bayer, Gyroscope, Ionis, Kodiak Sciences, NGM Bio, Oxurion, Regenxbio, Regeneron, Sandoz, Code C (Consultant/Contractor), Alimera, Genentech, Inc., Ophthea, Code S (non-remunerative); Aachal Kotecha Roche Products Ltd., Code E (Employment); Jeffrey Willis Genentech, Inc., Code E (Employment); Audrey Souverain F. Hoffmann-La Roche, Code E (Employment); Eugene Shildkrot Genentech, Inc., Code E (Employment); philippe margaron F. Hoffmann-La Roche Ltd., Code E (Employment)
  • Footnotes
    Support  Genentech, Inc., South San Francisco, CA, provided support for the study and participated in the study design; conducting the study; and data collection, management, and interpretation.
Investigative Ophthalmology & Visual Science June 2023, Vol.64, 2185. doi:
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      Giuseppe Querques, Nikolas London, Aachal Kotecha, Jeffrey Willis, Audrey Souverain, Eugene Shildkrot, philippe margaron; Faricimab rapidly improves fluid parameters in patients with nAMD. Invest. Ophthalmol. Vis. Sci. 2023;64(8):2185.

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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.

 

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