The FDA has approved marketing Juvéderm Vollure XC for correcting moderate-to-severe wrinkles and folds, such as nasolabial folds, in adults aged 21 years and older, according to a news release from Allergan.
In a clinical U.S. trial, a majority (59%) of people treated with Juvéderm Vollure XC, which is formulated with Allergan’s proprietary Vycross technology that blends different molecular weights of hyaluronic acid, had improvement of moderate-to-severe nasolabial folds up to 18 months, according to the release.
Overall, 82% of patients reporting being very satisfied at 6 months and 68% reporting being very satisfied at 18 months.
“What’s exciting about Juvéderm Vollure XC is that it was shown to last up to 18 months from the initial or touch-up injection in a majority of subjects, which is the longest lasting result shown in a clinical study in the nasolabial folds,” Joely Kaufman, MD, a board-certified dermatologist and clinical trial investigator, stated in the release. “As the number of patients seeking dermal filler treatments continues to grow, I am pleased that the technology created by Allergan has also followed that same trend, with a full range of products that will allow for tailoring of treatment based on specific patient needs.”
Juvéderm Vollure XC includes a balance of gel firmness and low cohesivity, which yields a versatile formulation that adds subtle volume for correcting moderate-to-severe facial wrinkles and folds.
The most common adverse events (AEs) in the clinical study were temporary injection site responses at the treatment site including swelling, tenderness, bruising, firmness lumps/bumps, redness, pain, discoloration, and itching, with most AEs resolving within 1 week, according to Allergan.
Juvéderm Vollure XC was approved in Europe as Juvéderm Volift in 2013, according to the release.
Allergan reports it expects Juvéderm Vollure XC to be available to physicians in April.