FDA Approves Galderma's Restylane Defyne for Chin Augmentation

Restylane Defyne is now approved for the augmentation and correction of mild to moderate chin retrusion in adults over the age of 21.

The U.S. Food and Drug Administration (FDA) has approved Restylane Defyne for the augmentation and correction of mild to moderate chin retrusion in adults over the age of 21.

Restylane Defyne is a hyaluronic acid (HA) dermal filler that was first approved in 2016 by the FDA for mid-to-deep injection into the facial tissue for the correction of moderate to severe deep facial wrinkles and folds, such as nasolabial folds, in people older than 21.

"My patients often come to me asking about new treatment options to continue looking their best. Many are surprised when I explain the impact of chin augmentation and how balancing the lower face is key to helping achieve total facial attractiveness," says Anne Chapas, MD, a dermatologist and dermatologic surgeon in New York and an investigator in clinical trials of Restylane Defyne for chin, in a news release. "The lower part of the face is constantly in motion, so it is important for patients to have the option of a dynamic filler like Restylane Defyne that is scientifically developed to adapt to their facial expressions."

Results of a pivotal Phase 3 clinical trial showed that most patients (74%) experienced significantly improved chin projection for up to 1 year as measured by the Galderma Chin Retrusion Scale (GCRS). Positive aesthetic outcomes following treatment were demonstrated through high levels of subject satisfaction in FACE-Q and Global Aesthetic Improvement Scale (GAIS) questionnaires. 

Fully 99 percent of patients reported improvement in the appearance of their chin projection (when asked at 12 weeks), while 96 percent of injectors said treatment improved the appearance of patients' chin projection up to 1 year. In the Phase 3 clinical trial, Restylane Defyne had a proven safety and tolerability profile. Eighty-six percent of patients did not experience any adverse events related to the treatment, and 96 percent of adverse events related to the treatment were mild in severity (23/24), with only one moderate event of injection site pain.

"This marks Galderma's 8th FDA aesthetics approval in 5 years, illustrating our long-term commitment to advancing aesthetics through new innovation," says Alisa Lask, General Manager and Vice President of the U.S. Aesthetics Business at Galderma. "The chin is the foundational anchor of the face that brings the rest of your features into balance. Consumers can now address the chin with a non-surgical, safe option from a brand that uses cutting-edge XpresHAn Technology to shape and produce long-lasting results."