VISION GAINS
VISION GAINS
Primary endpoint was defined as the mean change from baseline in BCVA (measured by the ETDRS letter score) at 1 year (average of weeks 48, 52, and 56) and was tested for non-inferiority using a margin of 4 letters.1
*After 4 monthly loading doses for the Variable arm and 6 monthly loading doses for the Q8W arm. Minimum interval post-loading phase was Q4W and maximum was Q16W. Extension-of-dosing-interval data are based on medians from the pivotal trials.
BCVA=best corrected visual acuity; DME=diabetic macular edema; ETDRS=Early Treatment Diabetic Retinopathy Study; ITT=intent to treat; LS=least squares; Q4W=every 4 weeks; Q8W=every 8 weeks; Q16W=every 16 weeks.
TREATMENT INTERVALS
VABYSMO Variable treatment intervals through week 561,10,12
Patients could have received 3 to 11 doses after the loading phase through week 56. Week 52 decision reflects week 56 visit.
†After 4 monthly loading doses.1
‡Similar results were observed in RHINE.10
DME=diabetic macular edema; Q4W=every 4 weeks; Q8W=every 8 weeks; Q12W=every 12 weeks; Q16W=every 16 weeks.
ANATOMICAL OUTCOMES
Change in CST from baseline through week 56 in DME10,12
Assessment and Limitations:
Reduction in CST (ILM-BM) over time was a prespecified secondary endpoint. P values (for superiority testing) are nominal and not adjusted for multiplicity; no formal statistical conclusion should be made based on the P values. Clinical significance has not been established, and conclusions regarding treatment effect cannot be drawn.12
Percentage of patients with absence of IRF in DME10,12
Assessment and Limitations:
Absence of IRF was a prespecified secondary endpoint. P values (for superiority testing) are nominal and not adjusted for multiplicity; no formal statistical conclusion should be made based on the P values. Clinical significance has not been established, and conclusions regarding treatment effect cannot be drawn.12
An actual patient's CST response: VABYSMO Q8W-Q12W DME Patient
An actual patient’s CST response: VABYSMO Q16W DME Patient
Actual patient OCT scans taken by YOSEMITE & RHINE investigators are representative of the average CST response. Individual results may vary.
CST=central subfield thickness; DME=diabetic macular edema; ILM-BM=inner limiting membrane-Bruch membrane; IRF=intraretinal fluid; ITT=intent to treat; OCT=optical coherence tomography; Q4W=every 4 weeks; Q8W=every 8 weeks; Q12W=every 12 weeks; Q16W=every 16 weeks.
VABYSMO [package insert]. South San Francisco, CA: Genentech, Inc; 2022.
VABYSMO [package insert]. South San Francisco, CA: Genentech, Inc; 2022.
Beovu® (brolucizumab) [package insert]. East Hanover, NJ: Novartis; 2020.
Beovu® (brolucizumab) [package insert]. East Hanover, NJ: Novartis; 2020.
Eylea® (aflibercept) [package insert]. Tarrytown, NY: Regeneron Pharmaceuticals, Inc; 2021.
Eylea® (aflibercept) [package insert]. Tarrytown, NY: Regeneron Pharmaceuticals, Inc; 2021.
LUCENTIS® (ranibizumab) [package insert]. South San Francisco, CA: Genentech, Inc; 2018.
LUCENTIS® (ranibizumab) [package insert]. South San Francisco, CA: Genentech, Inc; 2018.
SUSVIMO™ (ranibizumab injection) [package insert]. South San Francisco, CA: Genentech, Inc; 2022.
SUSVIMO™ (ranibizumab injection) [package insert]. South San Francisco, CA: Genentech, Inc; 2022.
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Wykoff C, et al. Lancet. Published online January 24, 2022. doi:10.1016/S0140-6736(22)00018-6
Wykoff C, et al. Lancet. Published online January 24, 2022. doi:10.1016/S0140-6736(22)00018-6
Heier J, et al. Lancet. Published online January 24, 2022. doi:10.1016/S0140-6736(22)00010-1
Heier J, et al. Lancet. Published online January 24, 2022. doi:10.1016/S0140-6736(22)00010-1
Data on file. South San Francisco, CA: Genentech, Inc.
Data on file. South San Francisco, CA: Genentech, Inc.
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