JUVÉDERM VOLLURE™ XC Approved by U.S. FDA for Correction of Facial Wrinkles and Folds in Adults over the Age of 21
First and Only Hyaluronic Acid (HA) Dermal Filler FDA Approved for the Correction of Moderate to Severe Wrinkles and Folds, such as Nasolabial Folds, That Lasts up to 18 Months
Juvederm Vollure Chevy Chase
DUBLIN, March 20, 2017 /PRNewswire/ — Allergan plc, a leading global pharmaceutical company that manufactures Kybella, Botox and other popular cosmetic products, 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 US pivotal clinical trial, a majority (59%) 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% of patients said they were very satisfied at 6 months and 68% 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,” said 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™ 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 Dr. Joely Kaufman, 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 1 week.
JUVÉDERM VOLLURE™ XC was first approved in Europe as JUVÉDERM VOLIFT® in 2013. The JUVÉDERM® family of products is marketed and sold in more than 80 countries outside the United States.
JUVÉDERM VOLLURE™ XC will be available to physicians in April 2017.