A total of 654 subjects were enrolled in the two identical Phase III randomized, multi-center, placebo-controlled, single dose, double blind trials
. In both trials, Jeuveau met the primary endpoint and demonstrated efficacy compared with placebo in the reduction of the severity of glabellar lines, defined as a 2-point composite improvement agreed upon by the physician and patient, at Day 30.
The BLA candidate is supported by the results from the company's two open label, repeat dose, long-term Phase II studies (EV-004 and EV-006) and two Phase III randomised, multi-centre, placebo-controlled, double blind trials
(EV-001 and EV-002).