Facial aesthetics are capturing significant attention with the latest news from Merz Aesthetics, even as ultrasound therapy advancements make headlines. The Food and Drug Administration (FDA) has approved Merz Aesthetics’ Xeomin (incobotulinumtoxinA) as the first and only neurotoxin in the United States indicated for the simultaneous treatment of upper facial lines, including forehead lines, frown lines, and crow’s feet. This approval marks a significant milestone in aesthetic medicine, offering a comprehensive solution for treating multiple facial lines with a single neurotoxin.
The recommended dose for improving the appearance of moderate to severe upper facial lines is 20 units for glabellar frown lines, 20 units for horizontal forehead lines, and 24 units for crow’s feet, totaling 64 units. Initially approved by the FDA in 2011 for the temporary improvement of moderate to severe glabellar lines and frown lines, Xeomin’s new indication broadens its therapeutic scope.
Facial Aesthetics Milestone: Samantha Kerr Highlights FDA Approval of Xeomin for Upper Facial Lines
Samantha Kerr, PhD, Chief Scientific Officer at Merz Aesthetics, emphasized the significance of this approval: “Xeomin is the first and only FDA-approved neurotoxin for the simultaneous treatment of upper facial lines. 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 was based on results from two double-blind, placebo-controlled Phase III trials, which included 730 adult participants randomly assigned to receive Xeomin or placebo. Both studies met their primary endpoints, with Xeomin demonstrating a significantly higher response rate than placebo at day 30 for all upper facial line areas. The treatment was well tolerated, with adverse events (AEs) related to treatment being mild to moderate. No treatment-related serious AEs were observed.
Despite its efficacy, Merz warns that treatment with Xeomin may cause problems with swallowing, speaking, or breathing anywhere from hours to weeks after an injection. Patients with breathing issues who use neck muscles to help them breathe may be at greater risk for serious breathing problems. Additionally, issues with swallowing may last for several months, potentially necessitating a feeding tube. Patients should not use Xeomin if they are allergic to its ingredients, have had allergic reactions to other botulinum toxin products, or have a skin infection at the planned injection site.
Facial Aesthetics Innovation: Patrick Urban Highlights Xeomin’s Performance and XTRACT Technology
The trials demonstrated Xeomin’s exceptional performance profile, with patient satisfaction reported over 14 months of multiple treatment cycles. Patrick Urban, President of North America at Merz Aesthetics, highlighted the proprietary XTRACT technology used in Xeomin: “Unlike other toxin treatments, we filter out all unnecessary ingredients in Xeomin, leaving only the essential components for treatment, which 90% of surveyed patients say they absolutely want in a neurotoxin treatment.”
Merz Aesthetics is also celebrating this approval amidst its recent partnership with Demi Lovato and the multi-channel, digital-first Beauty on Your Terms campaign launched in August 2022. The campaign targets young adults new to injectables, aiming to empower and encourage them to embrace beauty on their own terms. Lovato, a Xeomin brand partner, shared her positive experience: “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.”
This FDA approval not only broadens the treatment options available for patients seeking aesthetic improvements but also underscores Merz Aesthetics’ commitment to innovation in the toxin space. By providing a solution that addresses multiple facial lines simultaneously, Xeomin offers a convenient and effective option for those looking to enhance their appearance.
As the aesthetics industry continues to evolve, the approval of Xeomin for the simultaneous treatment of upper facial lines represents a significant advancement. The ability to treat forehead lines, frown lines, and crow’s feet with a single product simplifies the treatment process and provides consistent, natural-looking results. Merz Aesthetics’ focus on efficacy, safety, and patient satisfaction ensures that Xeomin will be a valuable addition to the range of treatments available to patients seeking to improve their facial aesthetics.
In conclusion, the FDA’s approval of Xeomin for the simultaneous treatment of upper facial lines marks a pivotal moment in aesthetic medicine. With its proven efficacy, safety profile, and innovative formulation, Xeomin offers a new standard of care for patients and practitioners alike. This development highlights the ongoing advancements in the field of aesthetics and the continuous efforts to meet the evolving needs of patients.
Resource: Buesiness Wire, July 23, 2024
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