FDA Approves New Cheek Filler from Galderma

FDA Approves New Cheek Filler from Galderma image

Restylane Contour for cheek augmentation is Galderma's first and only product in the U.S. to use proprietary XpresHAn Technology for the cheeks.

The U.S. Food and Drug Administration (FDA) approved Galderma’s Restylane Contour for cheek augmentation and correction of midface contour deficiencies in adults over the age of 21.

Restylane Contour, a new hyaluronic acid (HA) dermal filler, is Galderma's first and only product in the U.S. formulated with XpresHAn Technology for the cheeks.  XpresHAn Technology uses a unique manufacturing process which creates a smooth, injectable gel that integrates into the skin for natural, dynamic expression in motion.

"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," said Dr. Leslie Baumann, M.D., a board-certified dermatologist in Miami and a lead investigator in the clinical trial of Restylane Contour, in a news release. "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."

"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," said 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."

The FDA approval of Restylane Contour is supported by data from a randomized, comparator-controlled, multi-center, pivotal Phase 3 study conducted at 15 centers across the United States. The study evaluated 270 patients across two groups over 48 weeks. Group A compared the effectiveness and safety of Restylane Contour (n=142) versus a control comparator (n=68). Group B compared the injection of Restylane Contour with needle (n=60) and cannula devices (n=60) in the same patient on each side of their face. Results showed that Restylane Contour is safe and effective for cheek augmentation and the correction of midface contour deficiencies. Patients treated with Restylane Contour required less total volume injected to achieve optimal aesthetic results compared to patients treated with the comparator (4.26 mL versus 4.88 mL, respectively). In Group A, ≥76 percent of patients* treated with Restylane Contour were 'satisfied' with their cheeks compared to ≥73 percent treated with the comparator across all FACE-Q questions through Week 48. Among patients in Group B, more than 91 percent were "satisfied" with their cheeks across all FACE-Q questions at all timepoints through Week 48.

In the Phase 3 study, Restylane Contour was well tolerated for cheek enhancement. The most commonly observed side effects for cheek injection were bruising, redness, swelling, pain, tenderness, and itching at the injection site. Most patients (85%) did not experience any adverse events (AEs) related to treatment with Restylane Contour. There were no severe or late-onset AEs related to Restylane Contour treatment, and 93 percent of AEs related to treatment with Restylane Contour were mild in intensity (53/57), with four moderate AEs of bruising, pain and/or facial pain. Restylane Contour showed comparable efficacy and safety when injected with needles and cannula devices.

Outside of the U.S., XpresHAn Technology is known as OBT and Restylane Contour is marketed as Restylane Volyme, which received its CE-mark in 2010 and has been used to treat more than 1.5 million patients worldwide to date.

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