Roche Pharmaceutical Development and Sales Overview
Vabysmo (faricimab, RG7716)
Bispecific antibody to simultaneously bind Ang-2 and VEGF-A
Indication
Center-involving diabetic macular edema (CI-DME)
Phase/study
# of patients
ARM A: Faricimab q8w
Design
Phase III
YOSEMITE
N=940
ARM B: Faricimab PTI up to q16w
ARM C: Aflibercept, q8w
Primary endpoint
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Change from baseline in BCVA at 1 year
FPI Q3 2018
Recruitment completed Q3 2019
Study met primary endpoint Q4 2020
Data presented at Angiogenesis 2021
Status
ā
ARM A: Faricimab q8w
Phase III
RHINE
N=951
ARM B: Faricimab PTI up to q16w
ARM C: Aflibercept, q8w
"
"
"
Change from baseline in BCVA at 1 year
FPI Q4 2018
Recruitment completed Q3 2019
Study met primary endpoint Q4 2020
Data presented at Angiogenesis 2021
Filed in US and EU Q2 2021
Published in the Lancet 2022 Feb 19;399(10326):741-755.
2-year data presented at Angiogenesis 2022
Approved in US Q1 2022 and EU Q3 2022
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CT Identifier
NCT03622580
Ang-2-Angiopoietin-2; VEGF-Vascular endothelial growth factor; PTI-Personalized Treatment Interval; BCVA-best corrected visual acuity
Roche
NCT03622593
99
99
OphthalmologyView entire presentation