June 2023
Volume 64, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2023
Durable vision gains and greater fluid control with extended faricimab dosing vs aflibercept in patients with DME
Author Affiliations & Notes
  • Jennifer I Lim
    Ophthalmology, University of Illinois Chicago, Chicago, Illinois, United States
    Ophthalmology, Illinois Eye and Ear Infirmary, Chicago, Illinois, United States
  • Shih-Jen Chen
    Taipei Veterans General Hospital, National Yang Ming Chiao Tung University, Taipei, Taiwan
  • Nathan Steinle
    Northern California Retina Vitreous Associates Inc, Mountain View, California, United States
  • Glenn J Jaffe
    Ophthalmology, Duke University School of Medicine, Durham, North Carolina, United States
    Duke Reading Center, Duke Medicine, Durham, North Carolina, United States
  • Bianca S Gerendas
    Vienna Reading Center, Medizinische Universitat Wien, Vienna, Wien, Austria
  • Francis Abreu
    Genentech Inc, South San Francisco, California, United States
  • Acner Camino
    Genentech Inc, South San Francisco, California, United States
  • Kara Gibson
    Roche Products Ltd, Welwyn Garden City, Hertfordshire, United Kingdom
  • Nitin Jain
    Roche Products Ltd, Welwyn Garden City, Hertfordshire, United Kingdom
  • Eugene Shildkrot
    Genentech Inc, South San Francisco, California, United States
  • Audrey Souverain
    F Hoffmann-La Roche AG, Basel, Basel-Stadt, Switzerland
  • Yannan Tang
    Genentech Inc, South San Francisco, California, United States
  • Jeffrey Willis
    Genentech Inc, South San Francisco, California, United States
  • Zdenka Haskova
    Genentech Inc, South San Francisco, California, United States
  • Footnotes
    Commercial Relationships   Jennifer Lim Allergan, Aura, Cognition, Eyenuk, Iveric Bio, JAMA Ophthalmology Editorial Board, Luxa, Novartis Pharma AG, Opthea, Quark, Regeneron, Roche/Genentech, Inc., Santen, Unity, Viridian, Code C (Consultant/Contractor), Adverum, Aldeyra, Chengdu Kanghong, Graybug, Janssen, NGM Bio, RegenexBio, Roche/Genentech, Inc., Spring Vision, Stealth, Code F (Financial Support), CRC Press/Taylor and Francis, Code P (Patent), Alimera, Code R (Recipient); Shih-Jen Chen Roche, Bayer, Code C (Consultant/Contractor), Allergan, Novartis, Code R (Recipient); Nathan Steinle Alimera, Allergan, Apellis, Bausch and Lomb, Genentech, Novartis, Opthea, Oyster Point Pharma, Regeneron, Regenxbio, Roche, Vortex Surgical, Zeiss , Code C (Consultant/Contractor), Genentech, Novartis, Regeneron, Regenxbio, Roche, Zeiss, Code F (Financial Support), Regeneron, Vortex Surgery, Code I (Personal Financial Interest); Glenn Jaffe 4D Molecular Therapeutics, Adverum, Annexon, Bausch + Lomb, EyePoint, Innovent, Novartis, Ripple, Roche/Genentech, Inc., Code C (Consultant/Contractor); Bianca S Gerendas Bayer, Novartis, Roche; Funding: Digital Diagnostics, Code C (Consultant/Contractor); Francis Abreu Genentech, Inc, Code E (Employment); Acner Camino Genentech, Inc, Code E (Employment); Kara Gibson Roche Products Ltd, Code E (Employment); Nitin Jain Roche Products Ltd, Code E (Employment); Eugene Shildkrot Genentech, Inc, Code E (Employment); Audrey Souverain F. Hoffman-La Roche Ltd, Code E (Employment); Yannan Tang Genentech, inc, Code E (Employment); Jeffrey Willis Genentech, Inc, Code E (Employment); Zdenka Haskova 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 Ellen M. Ross, PhD, of Envision Pharma Group and funded by F. Hoffmann-La Roche Ltd.
Investigative Ophthalmology & Visual Science June 2023, Vol.64, 2815. doi:
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    • Get Citation

      Jennifer I Lim, Shih-Jen Chen, Nathan Steinle, Glenn J Jaffe, Bianca S Gerendas, Francis Abreu, Acner Camino, Kara Gibson, Nitin Jain, Eugene Shildkrot, Audrey Souverain, Yannan Tang, Jeffrey Willis, Zdenka Haskova; Durable vision gains and greater fluid control with extended faricimab dosing vs aflibercept in patients with DME. Invest. Ophthalmol. Vis. Sci. 2023;64(8):2815.

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

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Abstract

Purpose : Dual angiopoietin-2 (Ang-2) and vascular endothelial growth factor (VEGF)-A pathway inhibition with faricimab may extend treatment durability beyond current anti-VEGF therapies for diabetic macular edema (DME). In YOSEMITE/RHINE, the personalized treat-and-extend–based regimen (T&E) was designed to evaluate the long-term potential of faricimab to reduce treatment burden for patients with DME while maintaining efficacy.

Methods : In YOSEMITE/RHINE (NCT03622580/NCT03622593), patients were randomized 1:1:1 to faricimab 6.0 mg T&E, faricimab 6.0 mg every 8 weeks (Q8W), or aflibercept 2.0 mg Q8W through week 100 (pooled N = 1891). In the T&E arms, patients received faricimab Q4W until central subfield thickness (CST) < 325 µm was achieved at or after week 12. Once achieved, personalized treatment intervals could be extended by 4 weeks (up to Q16W), maintained, or reduced by 4 or 8 weeks (as low as Q4W) based on prespecified CST or best-corrected visual acuity (BCVA) criteria-driven decisions.

Results : Among patients randomized to faricimab T&E (pooled N = 632), 62% achieved Q16W dosing and 78% achieved ≥ Q12W dosing at week 96 (Fig 1) while achieving comparable BCVA gains and greater anatomical benefits, including earlier and sustained fluid control through 2 years, vs aflibercept. Most faricimab-treated patients who achieved ≥ Q12W dosing at week 52 (79%) maintained ≥ Q12W dosing without an interval reduction below Q12W through week 96, and most patients who achieved Q16W dosing at week 52 (76%) maintained Q16W dosing through week 96. Only 3.9% of patients remained on Q4W dosing throughout the 2-year trials (Fig 1). Faricimab T&E dosing dynamics through week 96, illustrative case studies, and a new exploratory data analysis into the parameters driving treatment interval decisions will be presented.

Conclusions : T&E with faricimab in YOSEMITE/RHINE provides relevant criteria-based guidance for clinical practice that offers vision gains and extended durability over 2 years for DME. These results support the potential for faricimab, via its novel mechanism of dual Ang-2/VEGF-A inhibition, to reduce treatment burden for patients with DME compared with currently available anti-VEGF therapies.

This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.

 

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