Evolus asserted the presentation of data from the Phase III comparative Clinical trial of its investigational prabotulinumtoxinA 900 kilodalton (kDa) neuromodulator at the American Academy of Dermatology meeting.
The European and Canadian Phase III study, EVB-0003 was presented by Berthold Rzany, MD during the AAD meeting on Saturday, February 17,2018. 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.
Rui Avelar, M.D., Chief Medical Officer of Evolus said “The EVB-003 data presentation marks a milestone achievement for the prabotulinumtoxinA clinical program.”
EVB-003 was a 150-day, multicenter, randomized, double-blind, active- and placebo-controlled, single-dose Phase III non-inferiority study. Adults aged 18 or older with moderate to severe glabellar lines at maximum frown, as assessed by the investigator on the 4-point Glabellar Line Scale (GLS, 0=no lines, 1=mild, 2=moderate, 3=severe), were enrolled provided that they also felt their glabellar lines had an important psychological impact. Randomization was 5:5:1 to receive a single treatment of 20 U prabotulinumtoxinA, 20 U onabotulinumtoxinA or placebo (0.9% saline).