The U.S. Food and Drug Administration (FDA) approved XEOMIN (incobotulinumtoxinA) for the simultaneous treatment of forehead lines, frown lines, and crow’s feet.
XEOMIN is also indicated for the temporary improvement in the appearance of moderate to severe glabellar lines.
The total recommended XEOMIN dose for treatment is 20 units for glabellar frown lines, 20 units for horizontal forehead lines and 24 units for the crow’s feet for a total of 64 units.
“XEOMIN is the first and only FDA-approved neurotoxin for the simultaneous treatment of upper facial lines (forehead lines, frown lines and crow’s feet lines),” says Dr. Samantha Kerr, Chief Scientific Officer at Merz Aesthetics, in a news release. “This new indication for XEOMIN proves we are moving the needle within the toxin space and meeting the needs of our consumers as it comes to efficacy and results, while containing only the essential ingredients needed for treatment.”
The approval for treatment of upper facial lines stems from clinical studies demonstrating the simultaneous treatment efficacy and safety of XEOMIN. The phase three 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. Results showed 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. The unique formulation of XEOMIN without unnecessary proteins had an excellent performance profile. Study data showed high patient satisfaction and continued efficacy over 14 months of multiple treatment cycles.
The new indication comes on the coattails of the brand’s partnership with Demi Lovato and the continuation of the Merz Aesthetics multi-channel, digital-first ‘Beauty on Your Terms’ campaign. First launched in August 2022, the campaign was developed to introduce XEOMIN to a younger, adult audience that is new to the injectables category and to empower them to embrace beauty on their own terms.
“Unlike other toxin treatments, we filter out all of the unnecessary ingredients in XEOMIN using proprietary XTRACT Technology, so we’re left with only the ingredients essential for treatment, which 90% of surveyed patients say they absolutely want in a neurotoxin treatment,” adds Patrick Urban, President, North America at Merz Aesthetics. “We’re so excited to hit this significant milestone for Merz Aesthetics as we continue to expand our ‘Beauty on Your Terms’ campaign and footprint within the aesthetics industry.”
Unnecessary proteins found in some other toxin formulations may cause an immune response which can lead to a decreased effect and failure of treatment. In a recent survey, just over 1 in 3 toxin users reported to have experienced decreased, or lessening effects, of toxin treatments. The double filtration and removal of unnecessary proteins of XEOMIN makes it less likely to lead to lessening or limiting results. The formulation minimizes the risk and offers a consistent experience across the new versatile indication.
