Roche Pharmaceutical Development and Sales Overview
Vabysmo (faricimab, RG7716)
Bispecific antibody to simultaneously bind Ang-2 and VEGF-A
Indication
Wet age related macular degeneration (wAMD)
Phase/study
# of patients
Design
Phase III
TENAYA
N=671
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ARM A: Faricimab 6.0mg q16w flexible after 4 IDs
ARM B: Aflibercept 2.0mg q8w after 3 IDs
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◉
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Change from baseline in BCVA week 40, 44 & 48
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Primary endpoint
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Status
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Phase III
LUCERNE
N=658
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
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 and EU Q3 2022
Π
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
100
Roche
OphthalmologyView entire presentation