FDA Approves Merz Aesthetics’ Xeomin for Simultaneous Treatment of Upper Facial Lines

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The 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. According to the company, to improve the appearance of moderate to severe upper facial lines, the recommended dose 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 was initially approved by the FDA in 2011 for temporary improvement in the appearance of moderate to severe glabellar lines and frown lines.¹

"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),” said Samantha Kerr, PhD, chief scientific officer, Merz Aesthetics, in a press 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 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. Merz states that both studies met their primary endpoints, with Xeonin demonstrating a significantly higher response rate than placebo at day 30 for all upper facial line areas. The treatment was found to be well tolerated, with adverse events (AEs) related to treatment being mild to moderate. No treatment-related serious AEs were observed.

Merz warns that treatment with Xeomin may cause problems with swallowing, speaking, or breathing anywhere from hours to weeks after an injection. It is recommended that patients with breathing issues should use muscles in their neck to help them breathe but also may be at greater risk for serious breathing problems. Additionally, issues with swallowing may last for a number of months, resulting in the need for a feeding tube to receive food and water. Patients should not use Xeomin if they are allergic to any of its ingredients, have had an allergic reaction to any other botulinum toxin products, or have a skin infection at the planned injection site.

According to investigators, Xeomin without unnecessary proteins demonstrated an exceptional performance profile and patient satisfaction was reported over 14 months of multiple treatment cycles.¹

“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,” said Patrick Urban, president, North America, Merz Aesthetics, in the press release. “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.”

Merz also expressed excitement that the approval came amid the brand’s recent partnership with Demi Lovato and its multi-channel, digital-first Beauty on Your Terms campaign, which was launched in August 2022 to target a young adult audience new to injectables. The goal of the campaign is to empower and encourage embracing beauty on their own terms.¹

“In my opinion and experience, Xeomin is the smart choice for treatment of my upper facial lines,” said Lovato, Xeomin brand partner, in the press release. “The SmartTox formula is double filtered with only the ingredients essential for treatment to give me natural-looking results treatment after treatment.”

Reference

1. Merz Aesthetics Announces FDA Approval of XEOMIN® (incobotulinumtoxinA) as the First and Only U.S. Neurotoxin for the Simultaneous Treatment of Upper Facial Lines. Business Wire. July 23, 2024. Accessed July 23, 2024. https://www.businesswire.com/news/home/20240723538247/en/Merz-Aesthetics-Announces-FDA-Approval-of-XEOMIN%C2%AE-incobotulinumtoxinA-as-the-First-and-Only-U.S.-Neurotoxin-for-the-Simultaneous-Treatment-of-Upper-Facial-Lines