FDA approves Xeomin as first neurotoxin for simultaneous treatment of facial lines
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Key takeaways:
- Xeomin is the first neurotoxin that can simultaneously treat frown lines, forehead lines and crow’s feet.
- Xeomin’s formulation is filtered to exclude unnecessary proteins that inhibit optimal results.
The FDA has approved Xeomin as the first and only neurotoxin for the simultaneous treatment of upper facial lines, Merz Aesthetics announced in a press release.
Previously approved in 2011 for the temporary improvement of moderate to severe glabellar frown lines, Xeomin (incobotulinumtoxinA)’s indication is now expanded to also include forehead lines and crow’s feet per this current approval from the FDA.
“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,” Samantha Kerr, PhD, chief scientific officer of Merz Aesthetics, said in the release.
According to the release, Xeomin has been filtered so that it contains only the ingredients necessary for treatment — a feature that 90% of patients surveyed by Merz Aesthetics say they want in a neurotoxin treatment. In fact, one in three patients have reported that they have experienced decreased results from their toxin treatments which may be attributed to the unnecessary proteins found in certain toxin formulations that cause the immune system to respond and lessen the effects of these toxin treatments.
The approval was supported by results from two phase 3, double-blind, placebo-controlled studies that included 730 adults who randomly received Xeomin or placebo. Results showed a much higher response rate among the Xeomin group vs. the placebo group by day 30 across all upper facial line areas.
No serious adverse effects were reported. Patients experienced high satisfaction and continued efficacy over 14 months including multiple treatment cycles, according to the release.
The total recommended Xeomin dose for treatment is 20 units for glabellar frown lines, 20 units for horizontal forehead lines and 24 units for crow’s feet, or 64 units overall.
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