VABYSMO Delivered Rapid & Sustained Vision Gains With Extended Dosing Intervals at Year 11*
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
VABYSMO met its primary endpoint vs aflibercept Q8W (FDA-approved dosing regimen)1,3
*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.