In December, Galderma received FDA approval for a pair of next-generation hyaluronic acid (HA) dermal fillers: Restylane Refyne and Restylane Defyne.
“Refyne was approved for the treatment of moderate to severe facial wrinkles and folds, such as the nasolabial folds, in patients over the age of 21,” Mitchel P. Goldman, M.D., a volunteer clinical professor of dermatology at the University of California, San Diego, tells Cosmetic Surgery Times.
Dr. Goldman says Refyne is a unique gel filler designed with XpresHAn Technology, “which allows for flexibility and support. It also provides options for individuals who crave natural-looking results that allow for natural expression and every day motion.”
Dr. Goldman is excited to offer Refyne to patients who are looking to address their “smile and laugh lines.”
Defyne was approved for the same indications and minimum patient age. It also incorporates XpresHAn Technology, “although the filler provides a higher level of support for deeper lines,” Dr. Goldman says.
Both products achieve natural-looking results and help to maintain expressions in motion, along with “a long-standing history of proven safety and efficacy,” Dr. Goldman says.
XpresHAn Technology creates gels that offer flexibility and support for varied individual needs. “The technology customizes the degree of HA crosslinking in each product, resulting in gels that work to deliver natural-looking results, whether you have moderate to severe lines and a little sagging, or deeper lines that need more lift,” Dr. Goldman says.
The two products are calibrated for smoothness and consistent textures, enabling the dual benefit of flexibility and distributed product integration.
The Phase 3 studies of Refyne and Defyne for FDA approval showed a clinically meaningful improvement in wrinkle severity for up to 12 months in most patients. At six weeks, 79% of Refyne subjects and 77% of Defyne subjects achieved at least a 1-grade improvement on the Wrinkle Severity Rating Scale (WSRS).
Galderma is hopeful that the two new product approvals will entice patients who have yet to try a dermal filler.
In addition, the Restylane family now constitutes the widest selection of HA dermal fillers in the U.S., according to the company.