Galderma Receives FDA Approval for Cheek Fillers

Galderma announced the U.S. Food and Drug Administration (FDA) has approved Restylane Contour for cheek augmentation and correction of midface contour deficiencies in adults over the age of 21. Restylane Contour is new hyaluronic acid dermal filler and is Galderma’s first product in the U.S. formulated with XpresHAn Technology for the cheeks. XpresHAn Technology uses a manufacturing process that creates a smooth, injectable gel that integrates into the skin for natural, dynamic expression in motion. Cheek filler searches have risen in popularity 218 percent  from 2018 to 2020. “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, M.D., a board-certified dermatologist in Miami. “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.”

The FDA approval of Restylane Contour is supported by data from a Phase 3 study conducted at 15 centers across the U.S. The study showed that Restylane Contour is safe and effective for cheek augmentation and the correction of midface contour deficiencies. The most commonly side effects for cheek injection were bruising, redness, swelling, pain, tenderness, and itching at the injection site. “In the past, it was all about volume for the cheeks, but consumers today are looking for natural-looking results, such as the dynamic expression provided by XpresHAn Technology,” says Diane Gomez-Thinnes, head of Galderma U.S. “Developed by leading innovators in the hyaluronic acid filler market, Restylane Contour delivers a treatment you can trust. While individual results may vary, 98 percent of Restylane Contour patients were pleased with their result at 1 year. The dynamic results truly speak for themselves.”

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