21 February 2018 - - Irvine, California-based medical aesthetics company Evolus, Inc. (NASDAQ: EOLS) has presented data from the European - Canadian Phase III comparative clinical trial of its investigational prabotulinumtoxinA 900 kilodalton neuromodulator at the American Academy of Dermatology meeting, the company said.
In the study, prabotulinumtoxinA and onabotulinumtoxinA, both 900 kDa botulinum toxin type A complexes, were studied in subjects with glabellar lines, also known as frown lines, between the eyebrows.
EVB-003 was a 150-day, multicenter, randomized, double-blind, active- and placebo-controlled, single-dose Phase III non-inferiority study. The primary efficacy endpoint was measured on Day 30 and a responder was defined as a glabellar line scale (GLS) score of 0 or 1 at maximum frown as assessed by the investigator.
A total of 540 were enrolled, with 245 receiving prabotulinumtoxinA, 246 receiving onabotulinumtoxinA, and 49 receiving placebo.
The study met the primary endpoint of non-inferiority at Day 30 with responder rates of 87.2% in the prabotulinumtoxinA group, 82.8% in the onabotulinumtoxinA group, and 4.2% in the placebo group.
The adverse event assessed as study-drug related was 15.5%, 14.6% and 4.1% in the prabotulinumtoxinA, onabotulinumtoxinA and placebo groups, respectively. There were no serious adverse events that were assessed as study-drug related.
Evolus is focused on providing physicians and their patients with expanded choices in aesthetic procedures and treatments. Its lead product candidate is an injectable 900 kDa purified botulinum toxin type A complex. The company focuses on the self-pay aesthetic market.