FDA Approval Announced for New Restylane Products Refyne and Defyne
Galderma announced on December 12th, 2016 the FDA approval for Restylane Refyne and Restylane Deflyne dermal fillers. These two new Restylane family products have been approved for the treatment of nasolabial folds (NLF), otherwise known as “laugh lines” for patients over the age of 21.
Restylane Defyne was approved for moderate to severe facial wrinkles and folds that are deeper under the skin where Restylane Refyne is for the treatment of regular moderate to severe wrinkles and folds. These gels are manufactured with XpresHAn Technology that offers a range of flexibility and support in the skin. Both Restylane products have shown to maintain effectiveness for up to one year.
“Even with current approved options, many of my patients are still looking for different solutions to treat their laugh lines,” said Steven Fagien, Boca Raton oculoplastic surgeon. “These new products are flexible and are designed to meet different patient needs. I am excited to offer these next-generation HA dermal fillers in my practice.”
“Restylane Refyne and Restylane Defyne are the latest FDA-approved advancements in HA dermal fillers and align with Galderma’s mission to help individuals achieve natural-looking results through treatments with a long-standing history of proven safely and efficacy,” said Dr. Kelly Huang, VP and General Manager of the US Aesthetic and Corrective business of Galderma. “We saw an opportunity to address a common concern for patients who have not yet tried a dermal filler by designing gels that provide natural-looking results. With these new brands, the Restylane family of products now represents the broadest offering of HA dermal fillers in the US.”