Galderma Laboratories has received U.S. Food and Drug Administration (FDA) approval for the use of Restylane Lyft, a hyaluronic acid dermal filler, with a small blunt tip cannula for cheek augmentation and the correction of age-related midface contour deficiencies in patients over the age of 21.
The approval was based on a 16-week multicenter, open-label, prospective study of 60 male and female subjects that assessed the safety and efficacy of Restylane Lyft with lidocaine for cheek augmentation and the correction of age-related midface contour deficiencies in conjunction with the use of a small blunt tip cannula in the midface. At 16 weeks post treatment, 98.3 percent of subjects showed improvement in both the right and left midface based on the treating investigator’s assessment using the Global Aesthetic Improvement Scale (GAIS). The filler was previously approved for lip augmentation with cannula.
“I am thrilled that the FDA has approved Restylane Lyft for midface via cannula. I prefer using a cannula vs. a needle when injecting specific areas of the face,” said Anne Chapas, MD, a board certified dermatologist in New York City and clinical trial investigator for Restylane Lyft for midface injection via cannula. “In my experience, the use of a cannula may be associated with less potential damage to blood vessels, help minimize patient bruising, help decrease swelling, and allow for minimized downtime.”