FDA Approved Juvéderm Vollure XC for Correction of Facial Wrinkles and Folds

Monday, March 20, 2017 | FDA Approval/Clearance , Fillers & Injectables , Allergan


The FDA has approved Allergan plc's Juvéderm Vollure XC for correction of moderate to severe facial wrinkles and folds, such as nasolabial folds, in adults over the age of 21. In the US pivotal clinical trial, a majority (59 percent) of subjects saw improvement in moderate to severe nasolabial folds for up to 18 months. Patient satisfaction in the pivotal study was also high with 82 percent of patients reporting that they were very satisfied at 6 months and 68 percent at 18 months.

Juvéderm Vollure XC is formulated with Allergan's proprietary Vycross technology, which blends different molecular weights of hyaluronic acid, contributing to the gel's duration. The first Allergan product featuring Vycross technology, Juvéderm Voluma XC was FDA-approved to increase volume lost due to aging in the cheek area, followed by Juvéderm Volbella XC, which is FDA-approved for lip augmentation and correction of perioral rhytids. Now with Juvéderm Vollure XC, the advanced Vycross technology yields a custom engineered injectable gel product that was studied in the nasolabial folds, the number one dermal treatment area. It delivers a long-lasting result—up to 18 months.

Juvéderm Vollure XC is specifically tailored with a balance of gel firmness and low cohesivity, yielding a versatile formulation that adds subtle volume for the correction of moderate to severe facial wrinkles and folds.

"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," said Joely Kaufman, MD, a board-certified dermatologist and clinical trial investigator. "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."

The most common side effects seen in the clinical study were temporary injection site responses at the treatment site such as swelling, tenderness, bruising, firmness lumps/bumps, redness, pain, discoloration, and itching. Most of these side effects resolved within one week.

Juvéderm Vollure XC will be available to physicians in April 2017.

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