Half-Year 2022 Financial and Clinical Trials Update
Vabysmo (faricimab)
Bispecific antibody to simultaneously bind Ang-2 and VEGF-A
Indication
Phase/study
# of patients
Design
Phase III
YOSEMITE
N=940
☐
ARM A: Faricimab q8w
-
ARM B: Faricimab PTI up to q16w
ARM C: Aflibercept, q8w
Center-involving diabetic macular edema (CI-DME)
■ ARM A: Faricimab q8w
Phase III
RHINE
N=951
■ ARM B: Faricimab PTI up to q16w
ARM C: Aflibercept, q8w
Primary endpoint
Status
▪ 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
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
CT Identifier
NCT03622580
Ang-2-Angiopoietin-2; VEGF-Vascular endothelial growth factor; PTI=Personalized Treatment Interval; BCVA-best corrected visual acuity
NCT03622593
121
Roche
OphthalmologyView entire presentation