Investor Presentaiton
LOVVOLUS
FDA
GUIDANCE FOR INDUSTRY
UPPER FACIAL LINES: DEVELOPING BOTULINUM TOXIN DRUG PRODUCTS
AUGUST 2014
EFFICACY ENDPOINTS
Success should be defined as achievement of a score of 0 or 1 and a two-
grade improvement from the baseline, on both the IA and the SSA scales
concurrently, to ensure clinical significance. Because it may be possible to
move to an adjacent category on the assessment scale with only a small
level of improvement, a one-grade change may not represent a clinically
meaningful intrasubject change.
Sponsors should evaluate duration of effect with a clinically and
statistically meaningful approach. Assessment measures for duration of
effect should be the same as for the primary efficacy endpoint.
Assessment of the duration of effect should reflect the time period for
which a clinically meaningful proportion of subjects maintain response.
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