XEOMIN® FDA Approved For Forehead, Frown Lines & Crow’s Feet

XEOMIN® (incobotulinumtoxinA), the only neurotoxin with double-filtered formula that removes unnecessary ingredients, has been approved by the U.S. Food and Drug Administration (FDA) as the first and only neurotoxin for simultaneous treatment of upper facial lines—forehead lines, frown lines and crow’s feet.

This new indication of XEOMIN® supports health care providers, as simultaneous treatment of upper facial lines, during the same session has become common practice. This new indication is also good news for patients.

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 of XEOMIN® removes unnecessary proteins that may cause an immune response which can lead to a decreased effect and failure of treatment. The unique formulation of XEOMIN® minimizes the risk and continues to offer a consistent experience with this expanded indication treatment after treatment.

The news was announced in an official statement as well as on LinkedIn From Patrick Urban, President at Merz Aesthetics.

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First approved in 2011, XEOMIN® was indicated for the temporary improvement in the appearance of moderate to severe glabellar lines, or frown lines. This new upper facial lines FDA approval adds the indication for the treatment of horizontal forehead lines and lateral canthal lines, or crow’s feet, in addition to the previous frown lines indication.

“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 Dr. Samantha Kerr, Chief Scientific Officer, Merz Aesthetics. “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.”

With this announcement, XEOMIN® is now indicated for the temporary improvement in the appearance of moderate to severe upper facial 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.

“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. “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.”

Xeomin is unique because the product filters out unnecessary proteins, which are found in some other toxin formulations and may cause an immune response which can lead to a decreased effect and failure of 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.

Learn more about XEOMIN or find a Pinch Provider near you for an at home appointment.

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