June 2023
Volume 64, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2023
Individualized faricimab dosing up to every 16 weeks maintains robust anatomic and vision outcomes through 2 years in nAMD
Author Affiliations & Notes
  • Varun Chaudhary
    Department of Surgery, Hamilton Regional Eye Institute, McMaster University, Hamilton, Ontario, Canada
  • 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 Ltd., Basel, Switzerland
  • Eugene Shildkrot
    Genentech Inc, South San Francisco, California, United States
  • Balakumar Swaminathan
    F. Hoffmann-La Roche Ltd, Mississauga, Ontario, Canada
  • philippe margaron
    F. Hoffmann-La Roche Ltd., Basel, Switzerland
  • Footnotes
    Commercial Relationships   Varun Chaudhary Alcon, Bayer, Novartis, Roche, Code C (Consultant/Contractor), Bayer, Novartis, Code F (Financial Support); Aachal Kotecha Roche Products Ltd., Code E (Employment); Jeffrey Willis Genentech Inc., Code E (Employment); Audrey Souverain F. Hoffmann-La Roche Ltd., Code E (Employment); Eugene Shildkrot Genentech Inc., Code E (Employment); Balakumar Swaminathan F. Hoffmann-La Roche Ltd, Code E (Employment); philippe margaron F. Hoffmann-La Roche Ltd, Code E (Employment)
  • Footnotes
    Support  F. Hoffmann-La Roche Ltd. (Basel, Switzerland) provided support for the study and participated in the study design; conducting the study; and data collection, management, and interpretation. Third-party writing assistance was provided by Nisha Yeotikar, PhD, of Envision Pharma Group and funded by F. Hoffmann-La Roche Ltd.
Investigative Ophthalmology & Visual Science June 2023, Vol.64, 5056. doi:
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      Varun Chaudhary, Aachal Kotecha, Jeffrey Willis, Audrey Souverain, Eugene Shildkrot, Balakumar Swaminathan, philippe margaron; Individualized faricimab dosing up to every 16 weeks maintains robust anatomic and vision outcomes through 2 years in nAMD. Invest. Ophthalmol. Vis. Sci. 2023;64(8):5056.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : Year 2 data from the TENAYA/LUCERNE (NCT03823287/NCT03823300) trials demonstrate that dual inhibition of the angiopoietin-2/vascular endothelial growth factor-A pathways with faricimab (FAR) promotes vascular stability and durable efficacy in patients with neovascular age-related macular degeneration (nAMD). This study evaluated patient-level imaging biomarkers and visual outcomes with a focus on personalized treat-and-extend-based (T&E) regimen decision making in patients treated for 2 years.

Methods : TENAYA/LUCERNE were randomized, active comparator–controlled, double-masked, 112-week trials. Treatment-naïve patients with nAMD were randomized to FAR 6.0 mg up to every 16 weeks (Q16W) after 4 initial Q4W doses or aflibercept (AFL) 2.0 mg Q8W through study end after 3 initial Q4W doses. Following protocol-defined disease activity assessments at weeks 20 and 24, FAR patients received fixed up to Q16W dosing until week 60, after which they followed a T&E regimen (personalized treatment interval per protocol). During the T&E period, FAR treatment interval decisions were based on clinically relevant markers of disease activity: changes in protocol-defined visual acuity (VA), retinal anatomy assessed with optical coherence tomography, or new macular hemorrhage.

Results : 1329 patients were enrolled (TENAYA, N = 671; LUCERNE, N = 658). Mean change in best-corrected VA and central subfield thickness (CST; averaged over weeks 104–112) were: FAR, 4.4 letters and −148.4 µm; AFL, 4.3 letters and −144.0 µm, respectively. FAR-treated patients received fewer injections than AFL-treated patients overall (week 108 median: 10 vs 15) and during the T&E phase (weeks 60–108 median: 3 vs 6). At week 112, > 60% of FAR-treated patients achieved Q16W dosing and 77.8% achieved ≥ Q12W dosing. Among patients who achieved Q16W dosing at week 60, 68.9% remained on Q16W without deviation during the T&E phase. Among patients who achieved Q12W dosing at week 60, 58.6% extended to Q16W dosing by week 112. FAR was well tolerated, with an acceptable safety profile. We will present representative cases of FAR-treated patients through year 2 of TENAYA/LUCERNE, including retinal images and treatment intervals.

Conclusions : Visual and anatomical improvements were maintained with individualized faricimab dosing in patients with nAMD, with more patients achieving Q16W dosing in year 2 of 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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