VISION GAINS
VABYSMO met its primary endpoint of non-inferiority vs aflibercept 2 mg in the mean change from baseline in BCVA at year 1 (avg. of weeks 40, 44, and 48).1
Primary endpoint was measured by the ETDRS letter score and tested for non-inferiority using a margin of 4 letters. Differences in LS means for VABYSMO were +0.7 letters (CI: [95%] -1.1, +2.5) in TENAYA; and 0.0 letters (CI: [95%] -1.7, +1.8) in LUCERNE.1
*After 4 monthly loading doses.1 See additional dosing interval information in the Treatment Intervals section.
ANATOMICAL OUTCOMES
Assessment and Limitations:
Reduction in CST (ILM-RPE) over time were 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.6
†After 4 monthly loading doses.1 See additional dosing interval information in the Treatment Intervals section.
Assessment and Limitations:
Retinal drying is defined as absence of IRF and SRF. Absence of IRF or SRF, and absence of IRF and SRF were prespecified secondary endpoints. 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.6
TREATMENT INTERVALS
Assessment and Limitations:
Percentages may not be generalizable to a broader nAMD population. Different inclusion/exclusion criteria and disease activity criteria may generate different results. Enrollment was limited to treatment-naive, newly diagnosed nAMD patients. The disease activity criteria utilized are not validated and the aflibercept arm was not dosed similarly, interpret percentages with caution.6
‡Q16W=weeks 28 and 44; Q12W=weeks 24, 36, and 48; Q8W=weeks 20, 28, 36, and 44.1
This patient was a participant with nAMD receiving VABYSMO in clinical trials. Individual results may vary.
No serious ocular adverse drug reactions were observed/reported in the treated eye.
BCVA=best corrected visual acuity; CST=central subfield thickness; ETDRS=Early Treatment Diabetic Retinopathy Study; ILM-RPE=inner limiting membrane-retinal pigment epithelium; IRF=intraretinal fluid; LS=least squares; nAMD=neovascular age-related macular degeneration; Q8W=every 8 weeks; Q12W=every 12 weeks; Q16W=every 16 weeks; SRF=subretinal fluid.
VABYSMO [package insert]. South San Francisco, CA: Genentech, Inc; 2023.
VABYSMO [package insert]. South San Francisco, CA: Genentech, Inc; 2023.
Beovu® (brolucizumab-dbll) [package insert]. East Hanover, NJ: Novartis; 2022.
Beovu® (brolucizumab-dbll) [package insert]. East Hanover, NJ: Novartis; 2022.
Eylea® (aflibercept) [package insert]. Tarrytown, NY: Regeneron Pharmaceuticals, Inc; 2023.
Eylea® (aflibercept) [package insert]. Tarrytown, NY: Regeneron Pharmaceuticals, Inc; 2023.
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.
Data on file. South San Francisco, CA: Genentech, Inc.
Data on file. South San Francisco, CA: Genentech, Inc.
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Sahni J, et al. Ophthalmology. 2019;126(8):1155-1170.
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