Merz Aesthetics, the world’s largest dedicated medical aesthetics business, announced today topline results from two pivotal phase 3 clinical studies demonstrating the efficacy and safety of Xeomin® (incobotulinumtoxinA) in the simultaneous treatment of upper facial lines (horizontal forehead lines, glabellar frown lines, and lateral canthal lines).
The phase 3 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 (horizontal forehead lines, glabellar frown lines, and lateral canthal lines).
Results showed a rapid onset of action – within a few days ‒ and 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.
“We are thrilled with these results, and they will be the basis to support a U.S. FDA filing for a Xeomin upper facial lines indication,” said Dr. Samantha Kerr, Chief Scientific Officer, Merz Aesthetics. “These studies are an important milestone in medical aesthetics, as Xeomin would be the first and only neurotoxin therapy approved to treat all three areas of the upper face simultaneously.”
Xeomin’s unique formulation without unnecessary proteins had an excellent performance profile. Study data showed high patient satisfaction and continued efficacy over multiple treatment cycles.
“Medical aesthetics is all about helping people look and feel their best so they can live better lives overall,” said lead investigator, Dr. John H. Joseph, MD. “In clinical practice, we are seeing an increasing demand for treating all three delicate areas of the face and these new data offer promising results with incobotulinumtoxinA as a potential single treatment that might help us to better serve our patients’ needs.”
Merz Aesthetics will submit these data as part of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) this year. The organization is also planning to submit these data to a peer-reviewed journal.
About the Phase 3 Clinical Studies
The findings reported today are from two phase 3 trials (NCT04594213, NCT04622254). These were prospective, randomized, double-blind, multi-center trials with a placebo-controlled main period followed by an open-label extension period where all subjects received Xeomin. The purpose of these studies was to investigate the safety and efficacy of Xeomin in the combined treatment of wrinkles in the upper face: horizontal forehead lines (HFL), glabellar frown lines (GFL) and lateral canthal lines (LCL).
The primary endpoints for both studies were the proportion of GFL, HFL and LCL responders at Day 30 based on the Merz Aesthetics Scale (MAS) for upper facial lines. The MAS for upper facial lines are photo numeric severity rating scales developed to objectively quantify the severity of the HFL, GFL, and LCL1 and have been utilized in prior NT 201 UFL studies2. A responder was defined as having a score of 0 (no) or 1 (mild) and at least a two-grade improvement from baseline to Day 30 for GFL, HFL and LCL at maximum contraction as assessed by both the investigator and the subject.
Safety endpoints included the incidence of treatment-emergent adverse events (TEAEs) during the main study period (baseline to Day 120) and TEAEs during the open-label period.
References
Flynn et al. Dermatol Surg. 2012 Feb doi: 10.1111/j.1524-4725.2011.02248.x
Kerscher et al. Dermatol Surg. 2015 Oct doi: 10.1097/DSS.0000000000000450
Trevidic et al. Dermatol Surg. 2017 Dec doi: 10.1097/DSS.0000000000001416
About Xeomin (incobotulinumtoxinA)
XEOMIN® (incobotulinumtoxinA) is a botulinum toxin type A approved by the U.S. Food and Drug Administration (FDA) to temporarily improve the look of moderate to severe frown lines between the eyebrows (glabellar lines) in adults. For more information, including Full Prescribing Information and Medication Guide, please visit www.xeominaesthetic.com. See below for Important Consumer Safety Information.
About Merz Aesthetics
Merz Aesthetics is a medical aesthetics business with a long history of empowering health care professionals, patients and employees to live every day with confidence. We aim to help people around the world look, feel and live like the best versions of themselves — however they define it. Clinically proven, its product portfolio includes injectables, devices and skin care treatments designed to meet each patient’s needs with high standards of safety and efficacy. Being family owned for more than 115 years, Merz Aesthetics is known for building unique connections with customers who feel like family. Merz Aesthetics’ global headquarters is in Raleigh, N.C., USA, with a commercial presence in 52 countries worldwide. It is also a part of Merz Group, which was founded in 1908 and is based in Frankfurt, Germany. Learn more at merzaesthetics.com.
Source:
Merz Aesthetics