Half-Year 2022 Financial and Clinical Trials Update
VABYSMO
Roche
Ophthalmology franchise: Vabysmo in nAMD
At 112 weeks Q16W dosing increases to ≥ 60%
Ph III (LUCERNE, TENAYA) in nAMD: Dosing intervals of patients at year 1 and 2
48 weeks
TENAYA
LUCERNE
Q8W
Q8W
20.3%
22.2%
Q16W
Q16W
44.9%
45.7%
Q12W
34.0%
Q12W
32.9%
Q12W + Q16W
79.7%
Q12W + Q16W
77.8%
112 weeks
TENAYA
LUCERNE
ASRS
NYC
ANNUAL MEETING 2022
Q8W
Q8W
18.8%
25.8%
Q16W
Q12W
Q16W
59.0%
14.3%
66.9%
Q12W
15.1%
Q12W + Q16W
74.1%
Q12W + Q16W
81.2%
•
New dual MoA to promote vascular stability, potentially leading to a more durable therapy with maintanance of long-term vision gains
Proportion of patients achieving Q16W dosing increased from >45% at week 52 to ≥ 60% at week 112; Vabysmo given at interval of up to every 4 months achieved comparable vision gains
and reductions in central subfield thickness (CST) versus aflibercept given every two months
At two years of treatment Vabysmo was well tolerated. No cases of retinal vasculitis or occlusive retinal vasculitis were reported in the Ph III studies
Ph Ill extension studies (AVONELLE-X in nAMD & Rhone-X in DME) for Vabysmo to generate long-term (up to 4 years) safety and tolerability data ongoing
Demetriades A.-M. et al., ASRS conference 2022; nAMD-neovascular age-related macular degeneration; BCVA-best-corrected visual acuity; CST-central subfield thickness; DME-diabetic macular edema; Q16W-every 16
weeks; MoA-mechanism of action; Eylea (aflibercept) is a registered trademark/product of Regeneron
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