Merz Aesthetics, the world’s largest dedicated medical aesthetics business, today announced the presentation of data from its medical aesthetics portfolio, including Xeomin® (incobotulinumtoxinA) and Radiesse® at the American Society of Dermatologic Surgery (ASDS) 2020 annual meeting taking place virtually from October 9 to 11.
“We’re excited to virtually participate at the ASDS meeting and share several data presentations from our leading treatment portfolio, which include findings on Xeomin’s safety and prolonged duration of effect in a dose-ranging study,” said Terri Phillips, M.D., Chief Medical Affairs Officer, Merz Aesthetics.
The following presentations will also be shared virtually at the ASDS meeting and are intended to enhance the exchange of scientific information. Products mentioned below have not been studied in combination use by Merz Aesthetics.
ORAL LATE-BREAKING SESSION
- IncobotulinumtoxinA demonstrates safety and prolonged duration of effect in a dose-ranging study for glabellar lines; Michael H. Gold, MD
Sunday, October 11, 2020, 10:45 AM – 10:48 AM – Eastern Time
This manuscript was also recently published in the October issue of the peer-reviewed Journal of Drugs and Dermatology (JDD).
ORAL ABTRACTS SESSIONS
- Is it possible to interfere in the eyebrow shape and positioning while injecting Incobotulinumtoxin A into the brow depressors and also the frontalis?; Carla Pecora, MD*
Saturday, October 10, 2020, 11:09 AM – 11:12 AM - Adaptation of Face Attractiveness; Kate Goldie, MD*
Sunday, October 11, 2020, 10:36 AM – 10:39 AM
SCIENTIFIC EPOSTER PRESENTATIONS
ePosters will be viewable by attendees for the duration of the meeting beginning on Friday, October 9 until Sunday, October 11.
- Calcium hydroxylapatite microspheres provide organization into unorganized collagen networks leading to improvement of skin attractiveness; Gabriela R. Casabona, MD
- B.UP technique: safety assessment, effectiveness and satisfaction: Report 10 cases; Rossana Vasconcelos, MD*
- Changing the architecture of the midface; Kate Goldie, MD*
*Merz-supported Investigator Initiated Trials
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, our product portfolio includes injectables, devices and skin care treatments designed to meet each patient’s needs with the highest standards of safety and efficacy. We are known for building unique connections with customers who feel like family. Our global headquarters is in Raleigh, N.C., USA, with locations in 32 countries worldwide. Merz Aesthetics is part of Merz Group, a family owned company founded in 1908 and based in Frankfurt, Germany. Learn more at merzaesthetics.com.
About the American Society for Dermatologic Surgery (ASDS)
The American Society for Dermatologic Surgery (ASDS) is the largest specialty organization exclusively representing dermatologic surgeons who have unique training and experience to treat the health, function and beauty of your skin. ASDS members are pioneers in the field. Many are involved in the clinical studies that bring popular treatments to revitalize skin and fill and diminish wrinkles to the forefront. Their work has helped create and enhance many of the devices that remove blemishes, hair and fat, and tighten skin. Dermatologic surgeons also are experts in skin cancer prevention, detection and treatment. As the incidence of skin cancer rises, dermatologic surgeons are committed to taking steps to minimize the life-threatening effects of this disease. For more information, visit asds.net. Follow ASDS Skin MD on Facebook, Twitter and Instagram. Locate a dermatologic surgeon in your area: asds.net/find.
PLEASE SEE BELOW FOR IMPORTANT SAFETY INFORMATION about XEOMIN®, INCLUDING BOXED WARNING
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INDICATIONS AND USAGE
XEOMIN® (incobotulinumtoxinA) for injection, for intramuscular use is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines with corrugator and/or procerus muscle activity in adult patients.
IMPORTANT SAFETY INFORMATION
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WARNING: DISTANT SPREAD OF TOXIN EFFECT See full prescribing information for complete BOXED WARNING. The effects of XEOMIN and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults, particularly in those patients who have underlying conditions that would predispose them to these symptoms. |
CONTRAINDICATIONS
Hypersensitivity reactions have been reported with botulinum toxin products (anaphylaxis, serum sickness, urticaria, soft tissue edema, and dyspnea). If serious and/or immediate hypersensitivity reactions occur further injection of XEOMIN should be discontinued and appropriate medical therapy immediately instituted. XEOMIN is contraindicated in patients with known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation.
Use in patients with an infection at the injection site could lead to severe local or disseminated infection. XEOMIN is contraindicated in the presence of infection at the proposed injection site(s).
WARNINGS AND PRECAUTIONS
- The potency units of XEOMIN are specific to the preparation and assay method used and are not interchangeable with other preparations of botulinum toxin products. Therefore, Units of biological activity of XEOMIN cannot be compared to or converted into Units of any other botulinum toxin products.
- Treatment with XEOMIN and other botulinum toxin products can result in swallowing or breathing difficulties. Patients with pre-existing swallowing or breathing difficulties may be more susceptible to these complications. When distant effects occur, additional respiratory muscles may be involved. Patients may require immediate medical attention should they develop problems with swallowing, speech, or respiratory disorders. Dysphagia may persist for several months, which may require use of a feeding tube. Aspiration may result from severe dysphagia [See BOXED WARNING].
- Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junctional disorders (e.g., myasthenia gravis or Lambert-Eaton syndrome) should be monitored particularly closely when given botulinum toxin. Patients with neuromuscular disorders may be at increased risk of clinically significant effects including severe dysphagia and respiratory compromise from typical doses of XEOMIN.
- Glabellar Lines: Do not exceed the recommended dosage and frequency of administration of XEOMIN. In order to reduce the complication of ptosis the following steps should be taken:
- avoid injection near the levator palpebrae superioris, particularly in patients with larger brow depressor complexes;
- corrugator injections should be placed at least 1 cm above the bony supraorbital ridge.
- XEOMIN contains human serum albumin. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases and variant Creutzfeldt-Jakob disease (vCJD). There is a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD), but if that risk actually exists, the risk of transmission would also be considered extremely remote. No cases of transmission of viral diseases, CJD or vCJD have ever been reported for albumin.
ADVERSE REACTIONS
Glabellar Lines: The most commonly observed adverse reaction (incidence ≥ 2% of patients and greater than placebo) for XEOMIN was Headache (5.4%).
DRUG INTERACTIONS
Co-administration of XEOMIN and aminoglycoside or other agents interfering with neuromuscular transmission, (e.g., muscle relaxants), should only be performed with caution as these agents may potentiate the effect of the toxin.
Use of anticholinergic drugs after administration of XEOMIN may potentiate systemic anticholinergic effects. The effect of administering different botulinum toxin products at the same time or within several months of each other is unknown. Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to the resolution of the effects of a previously administered botulinum toxin.
USE IN PREGNANCY
There are no adequate data on the developmental risk associated with the use of XEOMIN in pregnant women. XEOMIN should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
PEDIATRIC USE
Safety and effectiveness of XEOMIN in patients less than 18 years of age have not been established.
Copyright © 2019 Merz North America, Inc. All rights reserved.
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IMPORTANT RADIESSE® SAFETY INFORMATION
RADIESSE® Injectable Implant is FDA-approved for subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds.
RADIESSE® is contraindicated for patients with severe allergies, known hypersensitivity to any of the components of RADIESSE®, and patients with bleeding disorders. Introduction of the product into the vasculature may lead to embolization, occlusion of the vessels, ischemia, or infarction.
Common adverse events seen in clinical studies of RADIESSE® injected in the face include bruising, redness, swelling, pain, and itching.
For complete safety information, including information on adverse events from post-market surveillance of RADIESSE®, please refer to the Instructions for Use at Radiesse.com. To report a problem with RADIESSE®, please call MyMerz Solutions at 1-844-469-6379.
Rx only
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Corporate Contact:
Alison Brown
Director, Global Corporate Communications
Merz Aesthetics
6501 Six Forks Road, Raleigh, NC 27615
(919) 302-3296
media@merz.com
Copyright © 2020 Merz Pharmaceuticals, LLC. All rights reserved.
MERZ AESTHETICS and XEOMIN are registered trademarks of Merz Pharma GmbH & Co. KGaA.