Merz Aesthetics, the world’s largest dedicated medical aesthetics business, announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental Premarket Approval Application (sPMA) for Radiesse® (+) Lidocaine injectable implant for deep injection (subdermal and/or supraperiosteal) for soft tissue augmentation to improve moderate to severe loss of jawline contour in adults over the age of 21. Radiesse Injectables represent the first and only calcium hydroxylapatite (CaHA) portfolio in the U.S. and Radiessse (+) is the first and only FDA-approved injectable treatment for jawline improvement.
“The jawline is an important structural component of the face and has a profound effect on an individual’s appearance. This approval provides our customers and their patients a non-surgical, effective and safe option to address loss of jawline contour,” said Dr. Samantha Kerr, Chief Scientific Officer, Merz Aesthetics.
CaHA is a unique category in the marketplace, with properties shown to provide immediate improvement as well as long term results due to collagen and elastin production (up to a year in most patients) in lower face wrinkles and folds. The first product in the portfolio, Radiesse, is indicated for correction of moderate to severe lower face wrinkles and folds and for the improvement of volume loss in the dorsum of the hands. Radiesse (+) is also approved for moderate to severe lower face wrinkles and folds, and the new indication brings the unique properties of CaHA to jawline treatment.
“A sagging jawline is a primary indicator of facial aging, and I regularly treat women and men who seek a well-contoured jawline for a more defined profile,” said Jeremy B. Green, MD, of Skin Associates of South Florida/Skin Research Institute. “With the approval of Radiesse (+), I can now offer my patients an FDA-approved, non-surgical treatment option that will immediately improve the appearance of their jawline.”
The Radiesse (+) jawline indication is based on a pivotal, prospective, randomized, controlled, evaluator-blinded study evaluating the safety and effectiveness of Radiesse (+) in 180 subjects aged 26-65 years of age, who presented with moderate to severe jawline volume loss and desired improvement of jawline volume and contour. The study duration was 60 weeks. The primary endpoint was defined as a subject who obtained ≥1-point improvement on the Merz Jawline Aesthetic Scale (MJAS) on both jawlines compared to baseline.
Radiesse (+) provided a clinically and statistically significant improvement in the contour of the jawline and overall satisfaction, with 75.6% of the treated subjects achieving at least a 1-point improvement on the MJAS on both jawlines at Week 12. No treatment-related serious adverse events (AEs) occurred. The most common (>3%) treatment-related AEs were injection site reactions (lumps/bumps/focal fullness, bruising, or pain) and were mild, transient (duration of less than 15 days) and resolved without sequelae.
“Over the past decade, aesthetics professionals have seen a steady rise in the number of patients seeking a more defined and contoured jawline. To meet this demand and tap into the unique attributes of Radiesse (+), Merz Aesthetics is excited to announce the FDA approval of the jawline indication,” said Patrick Urban, President, North America, Merz Aesthetics.
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.
Corporate Contact:
Merz Aesthetics
6501 Six Forks Road
Raleigh, NC 27615
+1.919.985.7939
AxCorpCommNA@Merz.com
RADIESSE® and RADIESSE® (+) IMPORTANT SAFETY INFORMATION:
Contraindications:
These products are contraindicated for patients with severe allergies manifested by a history of anaphylaxis, or history or presence of multiple severe allergies; patients with known hypersensitivity to any of the components; and patients with bleeding disorders. RADIESSE® (+) is contraindicated in patients with known hypersensitivity to lidocaine or anesthetics of the amide type.
Warnings:
Introduction of the product into the vasculature may lead to embolization, occlusion of the vessels, ischemia, or infarction. Take extra care when injecting soft tissue fillers, for example inject the product slowly and apply the least amount of pressure necessary. Rare but serious adverse events associated with the intravascular injection of soft tissue fillers in the face have been reported and include temporary or permanent vision impairment, blindness, cerebral ischemia or cerebral hemorrhage, leading to stroke, skin necrosis, and damage to underlying facial structures. Immediately stop the injection if a patient exhibits any of the following symptoms, including changes in vision, signs of a stroke, blanching of the skin, or unusual pain during or shortly after the procedure. The treating physician should be knowledgeable regarding any pretreatment evaluation and appropriate interventions in the event of intravascular disseminated injection. Prompt intervention by an appropriate medical specialist should be given should these signs or symptoms of intravascular injection occur.
Use of these products in any person with active skin inflammation or infection in or near the treatment should be deferred until the inflammatory or infectious process is controlled.
Do not overcorrect (overfill) a contour deficiency with these products.
The safety and effectiveness for use in the lips has not been established. There have been published reports of nodules associated with the use of these products injected into the lips.
Precautions:
In order to minimize the risk of potential complications, this product should only be used by healthcare practitioners who have appropriate training, experience and who are knowledgeable about the anatomy at and around the injection site. Healthcare practitioners should fully familiarize themselves with the product, the product educational materials and the entire package insert.
The safety and effectiveness of RADIESSE® or RADIESSE® (+) in the following situations has not been established:
• Beyond 3 years in the face
• In the periorbital area
• Interactions between RADIESSE® or RADIESSE® (+) and drugs or other substances or implants
• Use during pregnancy, or in breastfeeding women
• In patients under 18 years of age
• In patients with increased susceptibility to keloid formation and hypertrophic scarring
• With concomitant dermal therapies such as epilation, UV irradiation, or laser, mechanical, or chemical peeling procedures
These products contain calcium hydroxylapatite (CaHA) particles that are radiopaque and are clearly visible on CT Scans and may be visible in standard, plain radiography.
As with all transcutaneous procedures, injection of these products carries a risk of infection.
Injection in the jawline may temporarily alter jaw function.
To help avoid needle breakage, do not attempt to straighten a bent needle or cannula. Discard it and complete the procedure with a replacement needle.
Patients who are using medications that can prolong bleeding, such as aspirin or warfarin, may experience increased bruising or bleeding at the injection site.
Patients with a history of previous herpetic eruption may experience reactivation of the herpes.
Patients should minimize strenuous activity and exposure of the treated area to extensive sun or heat exposure for approximately 24 hours after treatment or until any initial swelling and redness has resolved.
Adverse Events:
Common adverse events observed in clinical studies of RADIESSE® or RADIESSE® (+) include bruising, redness, swelling, pain, itching, lumps/bumps at site of injection, difficulty chewing and other local side effects.
Information on adverse events from post-market surveillance of RADIESSE® and RADIESSE® (+) are included in the Instructions for Use (IFU) and Patient Information Guide (PIG) based on an assessment of seriousness and potential causal relationship to RADIESSE® or RADIESSE® (+). Please see the IFU and PIG available at www.radiesse.com for a complete list of these events.
To report a problem with RADIESSE® or RADIESSE® (+), please call MyMerz Solutions at
1-844-469-6379.
For complete Safety Information please refer to the Instructions for Use at Radiesse.com.
Rx only
References
1. Tzikas TL. A 52-month summary of results using calcium hydroxylapatite for facial soft tissue augmentation. Dermatol Surg. 2008;34 Suppl 1:S9-15.
2. Jansen DA, Graivier MH. Evaluation of a calcium hydroxylapatite-based implant (Radiesse) for facial soft-tissue augmentation. Plast Reconstr Surg. 2006;118(3 Suppl):22S-30S, discussion 31S-33S.
3. Bass LS, Smith S, Busso M, McClaren M. Calcium hydroxylapatite (Radiesse) for treatment of nasolabial folds: long-term safety and efficacy results. Aesthet Surg J. 2010;30(2):235-238.
4. Yutskovskaya Y, Kogan E, Leshunov E. A ran¬domized, split-face, histomorphologic study comparing a volumetric calcium hydroxylapatite and a hyaluronic acid-based dermal filler. J Drugs Dermatol. 2014;13(9):1047-1052.
5. González N, Goldberg DJ. Evaluating the effects of injected calcium hydrox¬ylapatite on changes in human skin elastin and proteoglycan formation. Dermatol Surg. 2019;45(4):547-551.
6. Moradi A, Shirazi A, David R. Nonsurgical chin and jawline augmentation using calcium hydrox¬ylapatite and hyaluronic acid fillers. Facial Plast Surg. 2019;35:140-148.
2021 Merz North America Inc. All rights reserved. MERZ AESTHETICS is a registered trademark of Merz Pharma GmbH & Co. KGaA. RADIESSE and RADIESSE (+) are registered trademarks of Merz North America, Inc. US-RAD-2100036