The FDA announced approval for a hyaluronic acid (HA) filler for the augmentation and correction of mild to moderate chin retrusion for adults aged 21 years and older.
This particular product has been on the market since 2016 as an approved treatment for the correction of moderate to severe deep facial wrinkles and folds. Due to a manufacturing process known as optimal balance technology, the product is delivered as a smooth gel that creates a natural movement when injected.
FDA approval is supported by recent studies on the safety and tolerability of the filler for chin enhancement. In total, 86% did not experience any adverse events (AEs). Of these AEs, 96% were mild in severity, and only one patient experienced a moderate AE of injection site pain.
In a phase 3 clinical trial, 74% of patients experienced a significant improvement in chin projection for up to 1 year as determined by their Galderma Chin Retrusion Scale score, and 86% felt that they had improved chin projection when asked at 12 weeks. Further, at 12 weeks, 99% of patients also indicated improvement in the appearance of their chin projection. Of the administering health care providers, 96% said the filler improved chin projection for up to 1 year.
Galderma receives FDA approval for Restylane® Defyne for chin augmentation. News release. Galderma; February 1, 2021. Accessed February 1, 2021. https://www.prnewswire.com/news-releases/galderma-receives-fda-approval-for-restylane-defyne-for-chin-augmentation-301218796.html