Results showed a rapid onset of action, and the simultaneous treatment of upper facial lines with Xeomin was well tolerated.
Two pivotal phase 3 clinical studies demonstrated the efficacy and safety of Xeomin (incobotulinumtoxinA) in the simultaneous treatment of horizontal forehead lines, glabellar frown lines, and lateral canthal lines, according to Merz Aesthetics.
Merz Aesthetics will submit these data as part of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) this year.
The phase 3 double-blind, placebo-controlled studies included 730 adult participants randomized to receive Xeomin or placebo. Both studies met their primary endpoints with Xeomin having a significantly higher response rate than placebo at Day 30 for all upper facial line areas (horizontal forehead lines, glabellar frown lines, and lateral canthal lines).
Results showed a rapid onset of action – within a few days ‒ and the simultaneous treatment of upper facial lines with Xeomin was well tolerated: all treatment-related adverse events were mild to moderate, and no treatment-related serious adverse events were observed.
“We are thrilled with these results, and they will be the basis to support a U.S. FDA filing for a Xeomin upper facial lines indication,” says Dr. Samantha Kerr, Chief Scientific Officer, Merz Aesthetics, in a news release. “These studies are an important milestone in medical aesthetics, as Xeomin would be the first and only neurotoxin therapy approved to treat all three areas of the upper face simultaneously.”
“Medical aesthetics is all about helping people look and feel their best so they can live better lives overall,” says lead investigator John H. Joseph, MD. “In clinical practice, we are seeing an increasing demand for treating all three delicate areas of the face and these new data offer promising results with incobotulinumtoxinA as a potential single treatment that might help us to better serve our patients’ needs.”
The organization is also planning to submit these data to a peer-reviewed journal.
