Merz Aesthetics, the world’s largest dedicated medical aesthetics business, today announced topline results from a Phase 2 clinical study demonstrating the safety and effectiveness of XEOMIN® (incobotulinumtoxinA) for the treatment of platysma prominence. Also known as neck bands, platysmal bands are vertical cords of muscle in the neck that can become more prominent during the natural aging process. Currently, XEOMIN® is indicated for the temporary improvement of moderate to severe upper facial lines (frown lines, forehead lines, & crow’s feet) in adults.
“We’re excited to share these encouraging results that pave the way for our pivotal Phase 3 program,” said Dr. Samantha Kerr, Chief Scientific Officer, Merz Aesthetics. “This Phase 2 study underscores our commitment to bringing our customers new safe, minimally invasive methods to help their patients look better, feel better and live better.”
The primary objective of the study was to evaluate the efficacy of a single treatment of Xeomin® as assessed by the change from baseline of platysmal band prominence at Week 2. The four-month randomized study evaluated the efficacy of three treatments of XEOMIN® versus placebo in 68 male and female adults with moderate to severe platysmal bands at maximum contraction. To assess these results, Merz Aesthetics designed and developed its own 5-grade, scientifically validated scale: the Merz Aesthetics Platysma Scale – Dynamic (MAPS-D).
The study met its primary endpoint. Based on the Merz Aesthetics’ Platysma Scale, there was a statistically significant improvement from baseline for all XEOMIN® treatment groups compared to Placebo. Additionally, at Week 2, study participants in all XEOMIN® treatment groups also showed significant improvement on the Global Aesthetics Improvement Scale versus Placebo.
Overall, XEOMIN® was well tolerated in the study, with no new or unexpected adverse reactions being observed. This positive data will be essential as Merz Aesthetics plans its pivotal Phase 3 program.
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 90 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.
About XEOMIN®
XEOMIN® (incobotulinumtoxinA) is a botulinum toxin type A and the first and only neurotoxin approved by the U.S. Food and Drug Administration (FDA) for the simultaneous treatment of upper facial lines – forehead lines, frown lines and crow’s feet. XEOMIN® is indicated for the temporary improvement in the appearance of moderate to severe upper facial lines. For more information, including Full Prescribing Information and Medication Guide, please visit www.xeominaesthetic.com.
Head-to-head studies evaluating the relative risk of immunogenicity due to the presence or absence of complexing/unnecessary proteins have not been performed.
Media Contact
Alison Brown
Global Corporate Communications
6501 Six Forks Road
Raleigh, NC 27615
919-302-3296
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 Full Prescribing Information and Medication Guide
- 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 upper facial lines (frown lines, forehead lines, and crow’s feet) in adults for a short period of time (temporary). Please see additional Important Safety Information below and Full Prescribing Information and Medication Guide at www.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 upper facial lines include:
- injection site bruising
These are not all the possible side effects of XEOMIN. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 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