Allergan announced that the company has received approval from the U.S. Food and Drug Administration (FDA) to market 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 U.S. 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: 82 percent of patients said they were very satisfied at 6 months and 68 percent at 18 months. "The FDA approval of Juvéderm Vollure XC demonstrates Allergan's imperative to develop next-generation HA fillers designed to meet different patient needs," says David Nicholson, chief research and development officer at Allergan. "This commitment to ongoing scientific research and development is one of the factors that make Juvéderm, the number one selling collection of dermal filler products."
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 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, 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 which was studied in the nasolabial folds, the number one dermal treatment area. It delivers a long-lasting result, up to 18 months, that patients appreciate. Juvéderm Vollure XC will be available to physicians in April.