Income Statement Presentation 2023 slide image

Income Statement Presentation 2023

VABYSMO Roche Vabysmo: Chosen disease criteria impacts dosing interval Vabysmo nAMD trials use vision or anatomical disease activity criteria, reflecting clinical practice¹ ≥ 5 letters BCVA loss vs avg. BCVA over previous 2 scheduled visits, due to nAMD* Different ≥Q12W disease criteria as applied to TENAYA/LUCERNE patients Stringent criteria (as actually applied in TENAYA/LUCERNE)** Treatment change if ANY criteria are met (based on criteria used in pivotal trials) OR ≥ 10 letters BCVA loss vs highest BCVA recorded over previous 2 scheduled visits, due to nAMD* Share of patients assigned to >Q12W dosing Assessment done at week 20 > 50 μm CST increase vs avg. OR OR CST over previous 2 scheduled visits ≥ 75 μm CST increase vs lowest CST recorded at OR either of previous 2 scheduled visits 22% macular hemorrhage*, due to nAMD activity Less stringent criteria (post hoc analysis) Treatment change if ALL criteria are met > 25 μm CST increase vs week Presence of new 4% 78% >Q12W Q8W >5 letters BCVA loss vs week 16 BCVA AND 16 CST or new macular hemorrhage 96% . Ph III TENAYA/LUCERNE trial with stringent patient-centric criteria resulted in 22% of patients being allocated to Q8W dosing Using less stringent criteria, only 4% of patients would have been assigned to Q8W dosing (post hoc analysis) 1 Heier et al. Lancet. 2022;399(10326):729-40; TENAYA (NCT03823287) & LUCERNE (NCT03823300); *per the investigator; **Additional patients with a missing Week 20 assessment were considered to have met disease activity criteria and were treated Q8W; Q8W-every 8 weeks; BCVA-best-corrected visual acuity; nAMD-neovascular age-related macular degeneration; CST=central subfield thickness; Note: This analysis is not intended as a cross-trial comparison; This analysis cannot predict whether faricimab-treated patients in TENAYA & LUCERNE would have achieved non-inferiority vs aflibercept 2mg if the treatment regimen had been modified; This analysis is not intended to state or imply long term efficacy or safety 33
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