FDA approves Restylane Contour cheek fillers
Restylane Contour has been approved by the FDA for cheek augmentation and the correction of midface contour deficiencies in adults older than 21 years, Galderma announced in a press release.
The injection consists of a hyaluronic acid dermal filler formulated with Galderma’s XpresHAn Technology, which manufactures a smooth, injectable gel.
“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,” Diane Gomez-Thinnes, head of Galderma U.S., said in the press release. “Developed by leading innovators in the hyaluronic acid filler market, Restylane Contour delivers a treatment you can trust. While individual results may vary, 98% of Restylane Contour patients were pleased with their result at 1 year.”
The approval follows a randomized, comparator-controlled, multi-center, phase 3 study on Restylane Contour that Galderma conducted in 15 centers across the U.S. The injection exhibited safety and efficacy for its approved uses. No severe or late adverse events occurred in connection with Restylane Contour.
Galderma plans on introducing the injection to aesthetic injector partners in the U.S. this summer.