Efficacy and Safety of Faricimab in Diabetic Macular Edema: Two-Year Results From the Phase 3 YOSEMITE and RHINE Trials

Track:
Retina
What:
Paper Presentation | Présentation d'article
When:
1:45 PM, Saturday 11 Jun 2022 (7 minutes)
How:

Authors: Geoff Williams, Philip J. Ferrone, Charles C. Wykoff, Ramin Tadayoni, Zdenka Haskova, David Silverman, Jane Ives, Karen Basu, Hugh Lin. 
Author Disclosure Block: G. Williams: Membership on advisory boards or speakers’ bureaus; Name of for-profit or not-for-profit organization(s); Bayer Novartis Roche. Membership on advisory boards or speakers’ bureaus; Description of relationship(s); Advisory Board. Funded grants or clinical trials; Name of for-profit or not-for-profit organization(s); Bayer Novartis Roche Allergan Chengdu Kanghong. Funded grants or clinical trials; Description of relationship(s); Clinical Trial. All other investments or relationships that could be seen by a reasonable, well-informed participant as having the potential to influence the content of the educational activity; Name of for-profit or not-for-profit organization(s); ArticDx. All other investments or relationships that could be seen by a reasonable, well-informed participant as having the potential to influence the content of the educational activity; Description of relationship(s); O. P.J. Ferrone: Membership on advisory boards or speakers’ bureaus; Name of for-profit or not-for-profit organization(s); Genentech Mckesson. Membership on advisory boards or speakers’ bureaus; Description of relationship(s); Advisory Board. Funded grants or clinical trials; Name of for-profit or not-for-profit organization(s); Allergan Genentech. Funded grants or clinical trials; Description of relationship(s); Clinical Trial. All other investments or relationships that could be seen by a reasonable, well-informed participant as having the potential to influence the content of the educational activity; Name of for-profit or not-for-profit organization(s); Genentech Regeneron ArticDx. All other investments or relationships that could be seen by a reasonable, well-informed participant as having the potential to influence the content of the educational activity; Description of relationship(s); O. C.C. Wykoff: Membership on advisory boards or speakers’ bureaus; Name of for-profit or not-for-profit organization(s); Adverum Allergan Bayer Chengdu Kanghong EyePoint Genentech Kodiak Novartis Opthea Regeneron RegenXBio Roche. Membership on advisory boards or speakers’ bureaus; Description of relationship(s); Advisory Board. Funded grants or clinical trials; Name of for-profit or not-for-profit organization(s); Chengdu Kanghong Cleraside Biomedical Genentech Graybug Vsion Kodiak Novartis Opthea Regeneron RgenXBio Roche Samsung Biopis. Funded grants or clinical trials; Description of relationship(s); Clinical Trial. R. Tadayoni: Membership on advisory boards or speakers’ bureaus; Name of for-profit or not-for-profit organization(s); AbbVie Alcon Allergan Apellis Bayer Chengdu Kanghong Iveric Bio Oculis Thea Roche. Membership on advisory boards or speakers’ bureaus; Description of relationship(s); Consultant. Funded grants or clinical trials; Name of for-profit or not-for-profit organization(s); Alcon Bayer Novartis Roche Allergan Chengdu Kanghong Oculis Roche Zeiss. Funded grants or clinical trials; Description of relationship(s); Clinical Trial. Z. Haskova: Any direct financial payments including receipt of honoraria; Name of for-profit or not-for-profit organization(s); Genentech Inc. Any direct financial payments including receipt of honoraria; Description of relationship(s); Employee. D. Silverman: Any direct financial payments including receipt of honoraria; Name of for-profit or not-for-profit organization(s); Roche Products Ltd.. Any direct financial payments including receipt of honoraria; Description of relationship(s); Employee. J. Ives: Any direct financial payments including receipt of honoraria; Name of for-profit or not-for-profit organization(s); Roche Products Ltd.. Any direct financial payments including receipt of honoraria; Description of relationship(s); Employee. K. Basu: Any direct financial payments including receipt of honoraria; Name of for-profit or not-for-profit organization(s); Roche Products Ltd.. Any direct financial payments including receipt of honoraria; Description of relationship(s); Employee. H. Lin: Any direct financial payments including receipt of honoraria; Name of for-profit or not-for-profit organization(s); Genentech Inc. Any direct financial payments including receipt of honoraria; Description of relationship(s); Employee.

Purpose: Faricimab is a bispecific antibody designed to inhibit Ang-2 and VEGF-A, promote vascular stability, and improve outcomes in DME. The YOSEMITE and RHINE trials investigate the efficacy, safety, and durability of faricimab versus aflibercept in patients with DME. 

Study Design: YOSEMITE (NCT03622580, N = 940) and RHINE (NCT03622593, N = 951) are randomized, double-masked, active comparator-controlled, 100-week trials. 

Methods: Patients were randomized to FAR 6 mg Q8W, FAR 6 mg per protocol-driven personalized treatment interval (PTI), or aflibercept (AFL) 2 mg Q8W. 

Results: The primary endpoint was met; mean 1-year BCVA gains with FAR Q8W (10.7 and 11.8 letters in YOSEMITE and RHINE) or FAR PTI (11.6 and 10.8 letters) were noninferior to AFL Q8W (10.9 and 10.3 letters). Anatomic outcomes (CST, fluid) favored FAR. At week 52, > 50% of the FAR PTI arm were on Q16W dosing; > 70% were on ≥Q12W dosing. Case examples will be presented. FAR was well tolerated; no reported vasculitis/occlusive retinitis. Please note that the two-year results will be presented at this meeting. These data are expected to be available by the end-of 2021. The below abstract reflects the results of the 1-year studies and will be updated accordingly. 

Conclusions: The phase 3 YOSEMITE and RHINE trials examined the efficacy, safety, and durability of faricimab in patients with DME. At 1 year, treatment with faricimab was noninferior to aflibercept for gains in BCVA and offered anatomic improvements and potential for extended dosing to Q16W. Faricimab was well tolerated, with low rates of intraocular inflammation and no cases of vasculitis or occlusive retinitis reported.

Speaker
Calgary Retina Consultants

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