The hyaluronic acid gel is designed to mimic bone for lower face shaping and uses a new technology to provide firmness.
Galderma announced that Restylane Shaype has received approval in the European Union under the Medical Device Regulation for the temporary augmentation of the chin. The product is a hyaluronic acid injectable engineered for deep injection to build and shape on bone, according to a press release from the company.
The injectable is designed to create a bone-mimicking effect that provides structural enhancement to the lower face without surgical intervention. According to Galderma, approximately one in four people express concerns regarding chin shape and lower face sagging, which can be influenced by age-related changes or genetic factors.
The product utilizes NASHA HD technology and is the firmest hyaluronic acid gel in the company’s portfolio. It is designed to allow healthcare professionals to shape the lower angles of the face using lower injection volumes than other products, the company reports.
“Hyaluronic acid fillers remain the irreplaceable hero at the center of modern aesthetic care, yet the ability to achieve structural support in the face without surgery has long been limited,” says Andrei Metelitsa, MD, cosmetic dermatologist and study investigator, in a release. “In my clinical practice, I have seen how Restylane Shaype can address this gap, supported by pivotal data demonstrating durable improvements in lower face structure and definition through 12 months, high patient satisfaction and strong willingness to repeat treatment.”
Clinical Study Results
In a 12-month clinical study, 83% of participants treated with the injectable showed improved facial structure and definition at three months. At the 12-month mark, 66% of participants maintained these improvements.
Data from the study also indicated that 84% of patients would agree to be treated with the product again, and up to 97% of patients would recommend the treatment to others. The injections are delivered via a new syringe designed to increase precision and control for the injector, according to Galderma.
The company noted that the bone-mimicking properties of the gel are intended to address aesthetic needs across various life stages, including structural changes associated with menopause or medication-driven weight loss that can impact bone density and skin health.
Assessment and Technique
To support the clinical use of the new injectable, Galderma developed the Shayping Technique. This methodology combines the company’s existing assessment tools and the Facial Assessment Scale to help clinicians systematically evaluate lower face anatomy and facial balance.
This assessment-led approach is designed to help identify individual patient priorities and is currently being used in ongoing investigations for other areas of the face, such as the jawline.
“The EU approval of Restylane Shaype represents an important regulatory milestone for Galderma and for injectable aesthetics more broadly,” says Baldo Scassellati Sforzolini, MD, PhD, global head of research and development at Galderma, in a release. “With approvals now spanning Europe, Canada, and Brazil, this first-and-only HA shaper is a valuable new addition to the overall aesthetic landscape, and to the Restylane portfolio, expanding clinicians’ ability to address structural concerns in ways that traditional HA fillers are not designed to.”
