Galderma announced that the FDA has approved Restylane Defyne, a HA dermal filler, for chin enlargement.
The beauty and pharmaceutical company Galderma recently announced that the FDA has approved Restylane Defyne for the enhancement and correction of mild to moderate chin recession in adults over 21 years of age.
Restylane Defyne, first approved in 2016, is a hyaluronic acid (HA) dermal filler originally used for medium to deep injection into facial tissues to treat moderate to severe facial wrinkles and folds.
Galderma uses its unique manufacturing process XpresHAN technology, known globally as Optimal Balance Technology (OBT), to create a smooth injectable gel that can easily blend into the skin for natural and dynamic movement.
“This marks the 8th time that Galderma has received FDA aesthetic approval in 5 years, and it shows that we have long-term commitment to promote aesthetics through new innovations,” Alisa Lask, general manager and vice president of Galderma’s American aesthetics business, said in a press release announcing the approval. “The chin is the foundation of the face and can balance your other characteristics. Consumers can now use non-surgical, safe options to solve chin problems. The brand uses cutting-edge XpresHAN technology to shape and produce long-lasting results.”
The approval of Restylane Defyne was obtained after data from a key Phase 3 clinical trial that supports its safety and tolerability in jaw enlargement. Of the patients in the study, 86% did not experience any treatment-related adverse events, and only one moderate event of injection site pain.
Ninety-nine percent of patients reported an improvement in the appearance of the protruding chin (when asked at 12 weeks), and 96% of the injectors stated that the treatment improved the appearance of the protruding chin for up to a year.
The trial showed that 74% of patients had a significant improvement in chin projection over a period of up to one year, compared to 86% at 12 weeks. This is measured using Gartner’s Chin Retraction Scale (GCRS). The aesthetic results after treatment were positive and were demonstrated by the high level of subject satisfaction in the FACE-Q and Global Aesthetic Improvement Scale (GAIS) questionnaires.
“My patients often come to me to ask about new treatment options to continue to maintain their best condition. Many people are surprised when I explain the effect of enlarged jaw and balance of the lower face is the key to help achieve full facial attractiveness,” Anne Chapas, MD, a board-certified dermatologist and dermatologist in New York, and an investigator for the Restylane Defyne Chin clinical trial, said in a press release. “The lower part of the face is always in motion, so it is important for patients to choose dynamic fillers such as Restylane Defyne, which have been scientifically developed to adapt to their facial expressions.”
Post time: Jul-22-2021