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
Primary endpoint
Status
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Phase III
TENAYA
N=671
ARM A: Faricimab 6.0mg q16w flexible after 4 IDs
ARM B: Aflibercept 2.0mg q8w after 3 IDs
Change from baseline in BCVA week 40, 44 & 48
Wet age related macular degeneration (wAMD)
Phase III
LUCERNE
N=658
ARM A: Faricimab 6.0mg q16w flexible after 4 IDs
ARM B: Aflibercept 2.0mg q8w after 3 IDs
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■ Change from baseline in BCVA week 40, 44 & 48
FPI Q1 2019
Recruitment completed Q4 2019
Study met primary endpoint Q1 2021
Data presented at Angiogenesis 2021
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FPI Q1 2019
Recruitment completed Q4 2019
Study met primary endpoint Q1 2021
Data presented at Angiogenesis 2021
Filed in US and EU Q2 2021
▪ Published in Lancet 2022 Feb 19;399(10326):729-740
Approved in US Q1 2022
■ 2-year data presented at ASRS 2022
CT Identifier
NCT03823287
BCVA-best corrected visual acuity; Ang-2-Angiopoietin-2; VEGF-Vascular endothelial growth factor; IDs-initiating doses; ASRS-American Society of Retina Specialists
NCT03823300
Roche
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OphthalmologyView entire presentation