Accepted abstracts and posters provide key updates on aesthetics products, including Xeomin® (incobotulinumtoxinA), Ultherapy® and Radiesse®
Merz, a global leader in medical aesthetics, today announced the presentation of data from its aesthetics products, including Xeomin® (incobotulinumtoxinA), Ultherapy®, and Radiesse®, at the American Society of Dermatologic Surgery 2019 Annual Meeting which is taking place in Chicago from October 24 to 27.
“Merz is excited to be back at ASDS this year and to support several data presentations,” said
Terri Phillips, MD, Vice President and Head of Global Medical Affairs at Merz. “We are dedicated to advancing the science behind our treatments and are proud to support healthcare providers around the world who use our products.”
“Thank you to Merz and its forward-thinking medical affairs team who have supported my research over the last two years,” said Carla Pecora, MD. “Because of this partnership, my data is being presented at ASDS which is an extremely meaningful milestone to me and my practice.”
The following presentations are intended to enhance the exchange of scientific information. Products mentioned below have not been studied in combination use by Merz.
ORAL LATE-BREAKING SESSION
• Improvement in anterior thigh and knee skin laxity in female patients after combination therapy with micro-focused ultrasound and dilute calcium hydroxylapatite filler; Margit Juhasz*
Friday, October 25, 2019, 7:29 – 7:34 AM
ORAL ABTRACT SESSION
• One21 technique: an individualized and customized treatment of the forehead wrinkles with a predictable eyebrow shaping using IncobotulinumtoxinA; Maria Valeria Pinheiro on behalf of Carla Pecora*
Saturday, October 26, 2019, 3:05 PM – 3:10 PM
SCIENTIFIC POSTER PRESENTATIONS
Scientific Posters will be located in the exhibit hall on Thursday, October 24 beginning at 12:00 p.m. until Saturday, October 26 at 2:00 p.m.
• #10: Optimizing patient outcomes by customizing treatment with Ultherapy® : gold standard consensus guidelines from an expert panel; Sabrina Fabi, John Joseph, Julia Sevi, Jeremy Green, Jennifer Deaver Peterson
• #11: Nonsurgical chin and jawline augmentation using Radiesse and hyaluronic acid fillers;
Amir Moradi, Azadeh Shirazi, Roy David
• #12: Optimizing biostimulation with Radiesse; Bartosch Nowag, Daniela Schäfer, Stefan Kippenberger, Nadja Zöller, Gabriela Casabona, Thomas Hengl
• #13: IncobotulinumtoxinA: A highly purified and precisely manufactured botulinum neurotoxin type A; Martina Kerscher, Rungsima Wanitphakdeedecha, Trindade de Almeida, Corey Maas, Jürgen Frevert
• #14: Consensus recommendations for the use of hyperdiluted Radiesse as a face and body biostimulatory agent; Ada Trindade de Almeida, Vinicius Figueredo, Ana Lúcia Gonzaga da Cunha, Gabriela Casabona, Joana Ribeiro Costa de Faria, Emerson Vicente Alves, Mauricio Sato, Adeíza Branco, Christine Guarnieri, Eliandre Palermo
• #15: Safety, tolerability, and efficacy of repeat-dose injections of incobotulinumtoxinA in the treatment of upper facial lines; Tanja Fischer, Gerhard Sattler, Gerd Gauglitz, Berthold Rzany, Ernst M. Noah, Welf Prager, Anita Rütter, Tatjana Pavicic, Eva Kristina Bee, Petra Weissenberger, Shahbaz Riaz, Martina Kerscher
* Merz-supported Investigator Initiated Trials
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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IMPORTANT SAFETY INFORMATION
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 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 Creutzfeldt-Jakob disease (CJD). No cases of transmission of viral diseases or CJD 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 antibiotics or other agents interfering with neuromuscular transmission, e.g., tubocurarine-type 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.
To find a XEOMIN provider, visit https://www.xeominaesthetic.com/find-a-provider/.
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IMPORTANT RADIESSE® SAFETY INFORMATION
RADIESSE Injectable Implant is FDA-approved for hand augmentation to correct volume loss in the dorsum of the hands.
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 observed in the clinical study of RADIESSE® injected into the dorsum of the hand include bruising, redness, swelling, pain, itching, nodule or bumps/ lumps, difficulty performing activities, loss of sensation and other local side effects.
For complete RADIESSE 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. To find a RADIESSE provider, visit https://www.radiesse.com/find-a-provider/
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IMPORTANT ULTHERAPY® SAFETY INFORMATION
For full product and safety information, including possible mild side effects of Ultherapy® , visit www.ultherapy.com. To find an Ultherapy provider, visit https://ultherapy.com/find-a-provider/.
Corporate Contact:
Jane Yarbrough
Corporate Communications
Merz Americas
6501 Six Forks Road Raleigh, NC 27615
(984) 218.0983
Jane.Yarbrough@merz.com
Copyright © 2019 Merz North America, Inc. All rights reserved. MERZ, the MERZ logo and XEOMIN are registered trademarks of Merz Pharma GmbH & Co. KGaA. Ultherapy is a registered trademark of Ulthera, Inc. Radiesse is a registered trademark of Merz North America, Inc.