June 2021
Volume 62, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2021
Efficacy, durability, and safety of faricimab in diabetic macular edema (DME): one-year results from the phase 3 YOSEMITE and RHINE trials
Author Affiliations & Notes
  • John A Wells
    Palmetto Retina Center, West Columbia, South Carolina, United States
  • Charles Clifton Wykoff
    Retina Consultants of Houston, Houston, Texas, United States
  • Jeffrey R Willis
    Genentech Inc, South San Francisco, California, United States
  • Zdenka Haskova
    Genentech Inc, South San Francisco, California, United States
  • Hugh Lin
    Genentech Inc, South San Francisco, California, United States
  • David Silverman
    Roche Products Ltd, Welwyn Garden City, Hertfordshire, United Kingdom
  • Anthony P Adamis
    Genentech Inc, South San Francisco, California, United States
  • Jane Ives
    Roche Products Ltd, Welwyn Garden City, Hertfordshire, United Kingdom
  • Francis Abreu
    Genentech Inc, South San Francisco, California, United States
  • Karen Basu
    Roche Products Ireland Limited, Dublin, Ireland
  • Ramin Tadayoni
    Université de Paris, Lariboisière, Saint Louis, and Fondation Adolphe de Rothschild Hospitals, Paris, France
  • Footnotes
    Commercial Relationships   John Wells, Adverum (C), Adverum (R), Alimera (R), Bayer (R), Genentech, Inc. (C), Genentech, Inc. (R), Iveric Bio (R), Kodiak Sciences (R), Neurotech (R), Regeneron (R), Roche (C), Roche (R); Charles Wykoff, Adverum (C), Adverum (R), Allergan (C), Bayer (C), Chengdu Kanghong Biotechnology (C), Chengdu Kanghong Biotechnology (R), Clearside Biomedical (R), EyePoint (C), Genentech, Inc. (C), Genentech, Inc. (R), Graybug Vision (R), Kodiak Sciences (C), Kodiak Sciences (R), Novartis (C), Novartis (R), Opthea (C), Opthea (R), Regeneron (C), Regeneron (R), RegenXBio (C), RegenXBio (R), Roche (C), Roche (R), Samsung Bioepis (R); Jeffrey Willis, Genentech, Inc. (E); Zdenka Haskova, Genentech, Inc. (E); Hugh Lin, Genentech, Inc. (E); David Silverman, Roche Products Ltd. (E); Anthony Adamis, Genentech, Inc. (E); Jane Ives, Roche Products Ltd. (E); Francis Abreu, Genentech, Inc. (E); Karen Basu, Roche Products (Ireland) Ltd. (E); Ramin Tadayoni, AbbVie Allergan (C), AbbVie Allergan (F), AbbVie Allergan (R), Alcon (C), Alcon (F), Apellis (C), Bayer (C), Bayer (F), Bayer (R), Genentech, Inc. (C), Genentech, Inc. (R), Iveric Bio (C), KHB (C), KHB (R), Novartis (C), Novartis (F), Novartis (R), Oculis (C), Oculis (R), Roche (C), Roche (R), Thea (C), Zeiss (F)
  • 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 Karina Hamilton-Peel, PhD, CMPP, of Envision Pharma Group and funded by F. Hoffmann-La Roche Ltd.
Investigative Ophthalmology & Visual Science June 2021, Vol.62, 1037. doi:
  • Views
  • Share
  • Tools
    • Alerts
      ×
      This feature is available to authenticated users only.
      Sign In or Create an Account ×
    • Get Citation

      John A Wells, Charles Clifton Wykoff, Jeffrey R Willis, Zdenka Haskova, Hugh Lin, David Silverman, Anthony P Adamis, Jane Ives, Francis Abreu, Karen Basu, Ramin Tadayoni; Efficacy, durability, and safety of faricimab in diabetic macular edema (DME): one-year results from the phase 3 YOSEMITE and RHINE trials. Invest. Ophthalmol. Vis. Sci. 2021;62(8):1037.

      Download citation file:


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

      ×
  • Supplements
Abstract

Purpose : Data from the phase 2 BOULEVARD trial and preclinical models suggest that dual inhibition of the angiopoietin-2 and VEGF-A pathways with faricimab, the first bispecific antibody designed for intraocular use, may reduce inflammation and vascular leakage, promote vascular stability, and improve outcomes beyond anti-VEGF monotherapy for DME. The phase 3 YOSEMITE and RHINE trials were designed to compare the efficacy, durability, and safety of faricimab with aflibercept in patients with DME.

Methods : YOSEMITE (NCT03622580) and RHINE (NCT03622593) are identical, randomized, double-masked, active comparator–controlled, 100-week, phase 3 trials of faricimab in treatment-naïve and previously anti-VEGF–treated patients with center-involving DME. Patients were randomized 1:1:1 to faricimab 6.0 mg every 8 weeks (Q8W) after 6 initial Q4W doses; faricimab 6.0 mg per personalized treatment interval (PTI) after 4 initial Q4W doses; or aflibercept 2.0 mg Q8W after 5 initial Q4W doses. The PTI algorithm is a protocol-driven regimen based on the treat-and-extend concept, using prespecified BCVA and CST criteria to adjust treatment intervals at active dosing visits. Noninferiority, followed by superiority in treatment-naïve patients and then the overall population, was assessed separately for each faricimab arm against aflibercept. The primary efficacy endpoint was mean change in BCVA from baseline averaged over weeks 48, 52, and 56. A key secondary endpoint was the proportion of patients with ≥ 2-step ETDRS-DRSS improvement from baseline; other endpoints included the proportion of patients gaining ≥ 15 ETDRS letters from baseline, change in CST from baseline, and the proportion of patients in the PTI arm on Q4W, Q8W, Q12W, or Q16W dosing at 1 year. Safety was assessed by the incidence and severity of ocular and nonocular adverse events.

Results : In BOULEVARD, faricimab Q4W demonstrated superior vision gains and greater improvements in diabetic retinopathy severity at week 24, and showed potential for extended durability in a 16-week off-treatment observation period, when compared with ranibizumab Q4W. YOSEMITE and RHINE are ongoing trials, with year 1 results to be presented at the meeting.

Conclusions : YOSEMITE and RHINE evaluate the efficacy, durability, and safety of faricimab Q8W or per PTI, a protocol-driven regimen based on treat-and-extend, in patients with DME.

This is a 2021 ARVO Annual Meeting abstract.

×
×

This PDF is available to Subscribers Only

Sign in or purchase a subscription to access this content. ×

You must be signed into an individual account to use this feature.

×