June 2022
Volume 63, Issue 7
Open Access
ARVO Annual Meeting Abstract  |   June 2022
Faricimab in neovascular age-related macular degeneration: updated week 48 efficacy, safety, and durability in the phase 3 TENAYA and LUCERNE trials
Author Affiliations & Notes
  • Nikolas London
    Retina Consultants San Diego, San Diego, California, United States
  • Robyn H Guymer
    Centre for Eye Research Australia Ltd, Melbourne, Victoria, Australia
    Royal Victorian Eye and Ear Hospital, Melbourne, Victoria, Australia
  • Anna-Maria Demetriades
    Genentech Inc, South San Francisco, California, United States
  • Carlos Quezada Ruiz
    Genentech Inc, South San Francisco, California, United States
  • David Silverman
    Roche Products Ltd, Welwyn Garden City, Hertfordshire, United Kingdom
  • Jane Ives
    Roche Products Ltd, Welwyn Garden City, Hertfordshire, United Kingdom
  • Karen Basu
    Roche Products Ireland Limited, Dublin, Ireland
  • Hugh Lin
    Genentech Inc, South San Francisco, California, United States
  • Footnotes
    Commercial Relationships   Nikolas London Alimera, Amgen, Genentech, Inc., Regenxbio, NGMbio, Kodiak, Opthea, Bayer, Regeneron, Sandoz, Annexon, Gyroscope, Ionis, Apellis, Oxurion, Code F (Financial Support); Robyn Guymer Apellis, Bayer, Novartis, F. Hoffman-La Roche Ltd., Genentech, Inc., Code C (Consultant/Contractor); Anna-Maria Demetriades Genentech, Inc., Code E (Employment); Carlos Quezada Ruiz Genentech, Inc., Code E (Employment); David Silverman Roche Products Ltd. , Code E (Employment); Jane Ives Roche Products Ltd. , Code E (Employment); Karen Basu Roche Products Ltd. , Code E (Employment); Hugh Lin Genentech, Inc., 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 Ashley Sizer, PhD, of Envision Pharma Group and funded by F. Hoffmann-La Roche Ltd.
Investigative Ophthalmology & Visual Science June 2022, Vol.63, 3120. doi:
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      Nikolas London, Robyn H Guymer, Anna-Maria Demetriades, Carlos Quezada Ruiz, David Silverman, Jane Ives, Karen Basu, Hugh Lin; Faricimab in neovascular age-related macular degeneration: updated week 48 efficacy, safety, and durability in the phase 3 TENAYA and LUCERNE trials. Invest. Ophthalmol. Vis. Sci. 2022;63(7):3120.

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

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Abstract

Purpose : Dual inhibition of angiopoietin-2 and vascular endothelial growth factor-A with faricimab, a bispecific antibody designed for intraocular use, may promote vascular stability and durable efficacy in patients with neovascular age-related macular degeneration (nAMD). Here we report updated week 48 results of the phase 3 TENAYA (NCT03823287) and LUCERNE (NCT03823300) trials, comparing efficacy, safety, and durability of faricimab with aflibercept in patients with nAMD.

Methods : Patients with nAMD (pooled N = 1329) were randomized 1:1 to faricimab up to every 16 weeks (Q16W; n = 665) or aflibercept every 8 weeks (Q8W; n = 664). After 4 initial doses every 4 weeks (Q4W), faricimab-treated patients were treated Q8W, every 12 weeks (Q12W), or Q16W based on prespecified central subfield thickness (CST) and best-corrected visual acuity (BCVA) criteria at weeks 20 or 24. The primary endpoint was mean change from baseline in BCVA averaged over weeks 40, 44, and 48. Secondary efficacy endpoints, including visual and anatomic outcomes and safety, were assessed Q4W through week 48.

Results : Faricimab up to Q16W treatment resulted in comparable visual acuity outcomes compared to aflibercept Q8W, including noninferior BCVA gains averaged over weeks 40–48 (+6.2 and +5.9 Early Treatment Diabetic Study letters, respectively). Anatomical outcomes were also comparable between treatment arms, including mean reductions in CST from baseline averaged over weeks 40–48. Regarding durability, at week 48, 45.3% of faricimab-treated patients were on Q16W dosing and 78.7% were on Q12W dosing or longer. Representative cases of patients achieving Q16W dosing and associated retinal images will be presented. Faricimab was well tolerated, with low rates of intraocular inflammation and no vasculitis or occlusive retinitis events reported.

Conclusions : Pooled data from TENAYA/LUCERNE demonstrate that through week 48, faricimab up to Q16W offered durable vision gains and meaningful anatomic improvements that were comparable with aflibercept Q8W and was well tolerated.

This abstract was presented at the 2022 ARVO Annual Meeting, held in Denver, CO, May 1-4, 2022, and virtually.

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