Xeomin Receives FDA Approval for Simultaneous Treatment of Upper Facial Lines
Key Insights
Xeomin (incobotulinumtoxinA) gains FDA approval as the first and only neurotoxin for simultaneous treatment of forehead lines (search), frown lines (search), and crow’s feet (search).
The approval stems from Phase 3 trials demonstrating Xeomin's efficacy and safety, with high patient satisfaction and continued efficacy over multiple treatment cycles.
Xeomin's unique formulation, devoid of unnecessary proteins, minimizes the risk of immune response and ensures consistent results, appealing to patients seeking essential ingredients.
Merz Aesthetics (search) announced that Xeomin (incobotulinumtoxinA) has received FDA approval as the first and only neurotoxin in the U.S. indicated for the simultaneous treatment of upper facial lines, including forehead lines (search), frown lines (search), and crow’s feet (search). This approval expands Xeomin's existing indication for glabellar lines (search), offering a comprehensive solution for upper facial aesthetics.
Clinical Trial Data
The FDA's decision was supported by data from two Phase 3 double-blind, placebo-controlled studies involving 730 adult participants. The studies demonstrated that Xeomin achieved a significantly higher response rate compared to placebo at Day 30 across all upper facial line areas. The simultaneous treatment was well-tolerated, with adverse events being mild to moderate, and no treatment-related serious adverse events were reported.
Unique Formulation
Xeomin distinguishes itself through its proprietary XTRACT Technology, which filters out unnecessary proteins, leaving only the essential ingredients for treatment. According to Patrick Urban, President, North America, Merz Aesthetics (search), 90% of surveyed patients prefer a neurotoxin treatment with only essential ingredients. This formulation minimizes the risk of immune response, which can lead to decreased efficacy, a concern reported by over one in three toxin users.
Expert Commentary
"Xeomin is the first and only FDA-approved neurotoxin for the simultaneous treatment of upper facial lines (forehead lines (search), frown lines (search) and crow’s feet (search) lines)," said Dr. Samantha Kerr, Chief Scientific Officer, Merz Aesthetics (search). "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."
Market Context
The approval aligns with Merz Aesthetics (search)' 'Beauty on Your Terms' campaign, which aims to introduce Xeomin to a younger demographic. The campaign emphasizes personalized aesthetic choices and empowers individuals to embrace their own definitions of beauty. Demi Lovato, Xeomin brand partner, stated, "In my opinion and experience, Xeomin is the smart choice for treatment of my upper facial lines... The SmartTox formula is double filtered with only the ingredients essential for treatment to give me natural-looking results treatment after treatment."
Dosing and Administration
The total recommended Xeomin dose for the simultaneous treatment of upper facial lines is 64 units, divided as follows: 20 units for glabellar frown lines (search), 20 units for horizontal forehead lines (search), and 24 units for crow’s feet (search).