Galderma announces the FDA-approval of HA dermal filler, Restylane Defyne for use in chin augmentation.
Galderma, an aesthetic pharmaceutical company, recently announced the FDA-approval of Restylane Defyne for augmentation and correction of mild-to-moderate chin retrusion in adults over the age of 21.
Restylane Defyne, first approved in 2016, is a hyaluronic acid (HA) dermal filler initially used for mid-to-deep injection into facial tissue for moderate-to-severe facial wrinkles and folds.
Galderma uses its unique manufacturing process, XpresHAn Technology, globally referred to as Optimal Balance Technology (OBT), to create a smooth injectable gel that easily integrates into the skin for natural and dynamic movement.
"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, in the press release announcing the approval. "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."
The approval of Restylane Defyne follows data from a pivotal phase 3 clinical trial which supports its safety and tolerability profile for chin augmentation. Of the patients studied, 86% did not experience any adverse events related to the treatment, with only one moderate event of injection site pain.
Ninety-nine percent of patients reported improvement in the appearance of their chin projection (when asked at 12 weeks), while 96% of injectors said treatment improved the appearance of patients' chin projection up to one year.
The trial shows that 74% of patients experienced significantly improved chin projection for up to one year, and 86% at 12 weeks, according to the release. This was measured using Galderma’s Chin Retrusion Scale (GCRS). Aesthetic outcomes following treatment were positive and demonstrated through high levels of subject satisfaction in FACE-Q and Global Aesthetic Improvement Scale (GAIS) questionnaires.
"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 board-certified dermatologist and dermatologic surgeon in New York and an investigator in clinical trials of Restylane Defyne for chin, in the 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."