RALEIGH, N.C.– Merz Aesthetics, the world’s largest dedicated medical aesthetics business, announced today the commercial launch of 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 Radiesse (+) is the first and only FDA-approved injectable treatment for jawline contour improvement. The U.S. Food and Drug Administration (FDA) approved the supplemental Premarket Approval Application (sPMA) in September 2021.
“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 stimulation of 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 an injectable biostimulator 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.”
“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 commercial launch and FDA approval of the jawline indication,” said Patrick Urban, President, North America, Merz Aesthetics.
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 Assessment 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 (mass, bruising, pain, nodule, edema, or swelling) and were mild, transient (duration of less than 15 days) and resolved without sequelae.
