European and Canadian Phase III head-to-head pivotal trial results comparing Jeuveau and BOTOX (EVB-003) were published recently in Aesthetic Surgery Journal, Evolus Inc reports.
“We are pleased that these data were accepted and published in the Aesthetic Surgery Journal, which is added validation of the rigor of the study,” says Rui Avelar, MD, Evolus Inc chief medical officer and head of research & development at Evolus Inc.
“We knew it was crucial to invest in this study to answer key questions about the clinical performance of these two 900 kDa neurotoxins, and now clinicians can review it and draw their own conclusions.”
“The results of this study are compelling and reinforce the clinical performance of Jeuveau, which is the first 900 kDa product to enter the US market in nearly 30 years,” states David Moatazedi, Evolus president and chief executive officer. “We look forward to launching Jeuveau in the coming weeks in the United States.”
EVB-003 was a 150-day, multicenter, randomized, double-blind, active- and placebo-controlled, single-dose Phase III non-inferiority study evaluating prabotulinumtoxinA and onabotulinumtoxinA, both 900 kDa botulinum toxin type A complexes, in subjects who felt their glabellar lines had an important psychological impact.
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), who met these criteria were enrolled. Randomization was 5:5:1 to receive a single treatment of 20 U prabotulinumtoxinA, 20 U onabotulinumtoxinA or placebo (0.9% saline), the company explains in a media release.
Jeuveau (prabotulinumtoxinA-xvfs) is a proprietary 900 kDa purified botulinum toxin type A formulation indicated for the temporary improvement in the appearance of moderate to severe glabellar lines in adults.
[Source: Evolus Inc]