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.
Contact
Alison Brown
Global Public Relations
Merz Aesthetics
6501 Six Forks Road
Raleigh, NC 27615
919-985-7947
Media@merz.com
XEOMIN® (incobotulinumtoxinA) IMPORTANT CONSUMER SAFETY INFORMATION
Read the Medication Guide before you start receiving XEOMIN (Zeo-min) and each time XEOMIN is given to you as there may be new information. The risk information provided here is not comprehensive.
To learn more:
- Talk to your health care provider or pharmacist
- Visit www.xeominaesthetic.com to obtain the FDA-approved product labeling
- Call 1-866-862-1211
Uses: XEOMIN is a prescription medicine that is injected into muscles and used to improve the look of moderate to severe frown lines between the eyebrows (glabellar lines) in adults for a short period of time (temporary). It is not known if XEOMIN is safe and effective in children under 18 years of age. Please see additional Important Safety Information below and Full Prescribing Information and Medication Guide at XeominAesthetic.com.
Warnings: XEOMIN may cause serious side effects that can be life threatening. Call your doctor or get medical help right away if you have any of these problems anytime (hours to weeks) after treatment with XEOMIN:
Problems with swallowing, speaking, or breathing can happen within hours to weeks after an injection of XEOMIN if the muscles that you use to breathe and swallow become weak. Death can happen as a complication if you have severe problems with swallowing or breathing after treatment with XEOMIN.
People with certain breathing problems may need to use muscles in their neck to help them breathe and may be at greater risk for serious breathing problems with XEOMIN.
Swallowing problems may last for several months, and during that time you may need a feeding tube to receive food and water. If swallowing problems are severe, food or liquids may go into your lungs. People who already have swallowing or breathing problems before receiving XEOMIN have the highest risk of getting these problems.
Spread of toxin effects. In some cases, the effect of botulinum toxin may affect areas of the body away from the injection site and cause symptoms of a serious condition called botulism. The symptoms of botulism include: loss of strength and muscle weakness all over the body, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing.
These symptoms can happen hours to weeks after you receive an injection of XEOMIN. These problems could make it unsafe for you to drive a car or do other dangerous activities.
Do not use XEOMIN if you are allergic to XEOMIN or any of the ingredients in XEOMIN (see the end of this Guide for a list of ingredients in XEOMIN), had an allergic reaction to any other botulinum toxin products such as rimabotulinumtoxinB (MYOBLOC®), onabotulinumtoxinA (BOTOX®, BOTOX® COSMETIC), or abobotulinumtoxinA (DYSPORT®) or have a skin infection at the planned injection site.
Before receiving XEOMIN, tell your doctor about all of your medical conditions, including if you:
- have a disease that affects your muscles and nerves (such as amyotrophic lateral sclerosis [ALS or Lou Gehrig’s disease], myasthenia gravis or Lambert-Eaton syndrome)
- have had any side effect from any other botulinum toxin in the past
- have a breathing problem such as asthma or emphysema
- have a history of swallowing problems or inhaling food or fluid into your lungs (aspiration)
- have bleeding problems
- have drooping eyelids
- have plans to have surgery
- have had surgery on your face
- are pregnant or plan to become pregnant. It is not known if XEOMIN can harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if XEOMIN passes into breast milk.
Tell your doctor about all of the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Talk to your doctor before you take any new medicines after you receive XEOMIN.
Using XEOMIN with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you have received XEOMIN in the past. Especially tell your doctor if you:
- have received any other botulinum toxin product in the last four months
- have received injections of botulinum toxin such as rimabotulinumtoxinB (MYOBLOC®), onabotulinumtoxinA (BOTOX®, BOTOX® COSMETIC) and abobotulinumtoxinA (DYSPORT®) in the past. Be sure your doctor knows exactly which product you received. The dose of XEOMIN may be different from other botulinum toxin products that you have received.
- have recently received an antibiotic by injection
- take muscle relaxants
- take an allergy or cold medicine
- take a sleep medicine
Ask your doctor if you are not sure if your medicine is one that is listed above. Know the medicines you take. Keep a list of your medicines with you to show your doctor and pharmacist each time you get a new medicine.
Possible Side Effects
XEOMIN can cause serious side effects that can be life threatening including allergic reactions. Symptoms of an allergic reaction to XEOMIN may include: itching, rash, redness, swelling, wheezing, asthma symptoms, or dizziness or feeling faint. Tell your doctor or get medical help right away if you get wheezing or asthma symptoms, or if you get dizzy or faint. “See Warnings.”
The most common side effect of XEOMIN in people with frown lines include:
- headache
These are not all the possible side effects of XEOMIN. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of XEOMIN
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your pharmacist or doctor for information about XEOMIN that is written for health professionals.
Active Ingredient: botulinum toxin type A
Inactive Ingredients: human albumin and sucrose