Evolus has reported positive data from a Phase III clinical trial evaluating prabotulinumtoxinA in comparison with onabotulinumtoxinA for the treatment of patients with glabellar lines, also known as ‘frown lines’ between the eyebrows.
EVB-003 is a 150-day, multicentre, randomised, double-blind, active and placebo-controlled, single-dose non-inferiority study.
Approximately 540 adults aged 18 or older were enrolled with moderate to severe glabellar lines at maximum frown, as assessed by the investigator on the four-point glabellar line scale.
Enrolled subjects stated that they felt their glabellar lines had an important psychological impact.
As part of the trial, patients were randomised at 5:5:1 ratio to receive a single treatment of 20 U prabotulinumtoxinA, 20 U onabotulinumtoxinA or placebo.
The primary efficacy objective of the EVB-003 trial was measured on day 30 and a responder was defined as a GLS score of zero or one at maximum frown following evaluation by the trial investigator.
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From the total enrolled patients, 245 received prabotulinumtoxinA, 246 had onabotulinumtoxinA, while 49 were given placebo.
According to Evolus, the trial met its 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% for placebo.
The trial reported 15.5% drug-related adverse events in prabotulinumtoxinA group, as well as 14.6% and 4.1% similar events in the onabotulinumtoxinA and placebo groups respectively. No serious adverse events were reported that were examined as study-drug related.
PrabotulinumtoxinA is a 900 kilodalton (kDa) purified botulinum toxin type A complex and its biologics licence application (BLA) is currently under review of the US Food and Drug Administration (FDA).
OnabotulinumtoxinA is also a 900 kDa botulinum toxin type A complex.