Galderma receives Restylane Contour FDA approval for cheek augmentation and correction of midface contour deficiencies.
Galderma today announced the FDA approval of Restylane Contour for cheek augmentation and correction of midface contour deficiencies in adults 21 years or older.
The new hyaluronic acid (HA) filler is Galderma’s only product in the United States formulated with XpresHAn Technology for the cheek.
The FDA approval is supported by data from a randomized, comparator-controlled, multicenter, phase 3 trial. The study enrolled 270 patients in 2 groups, Group A and Group B. Group A was separated into 2 treatment arms, the Restylane Contour arm (142 patients) vs the control arm (68 patients) to compare safety and efficacy. Group B contained 60 patients treated with Restylane Contour injection and then cannula on each side of the face.
The study data demonstrated that Restylane Contour is safe and effective for cheek augmentation and the correction of midface contour deficiencies with patients who were treated and required less total volume of Restylane injection (4.26 mL) to receive results compared to placebo (4.88 mL), according to a press release announcing the approval.
Group A had greater than 76% of patients treated with Restylane and rated themselves as satisfied with their results vs less than 73% of comparator at week 48. In Group B, it was more was 91% of patients who reported being satisfied.
The safety data showed that Restylane Contour was well tolerated and the most common adverse events (AEs) were bruising, redness, swelling, pain, tenderness, and itching at injection site. However, 85% did not experience any AEs over the course of the trial. There were no severe or late on-set AEs and 93% of AEs were mild in intensity.
“Cheeks are the cornerstone of the face and focusing on natural contour and not just volume loss can result in a dynamic expression that amplifies their natural beauty,” says Leslie Baumann, MD, a board certified dermatologist in Miami, Florida, and a lead investigator in the clinical trial of Restylane Contour. “Hyaluronic acid levels in the skin diminish as we age, causing the face to lose shape, while increasing the likelihood that wrinkles and folds will appear.”
1. Galderma receives FDA approval for Restylane contour for cheek augmentation and correction of midface contour deficiencies. BioSpace. June 29, 2021. Accessed June 29, 2021. https://www.biospace.com/article/galderma-receives-fda-approval-for-restylane-contour-for-cheek-augmentation-and-correction-of-midface-contour-deficiencies/