FDA OKs Longer-Lasting Juvéderm Vollure XC for Laugh Lines

Megan Brooks

Disclosures

March 20, 2017

The US Food and Drug Administration (FDA) has approved Juvéderm Vollure XC (Allergan) for injection into facial tissue to correct moderate to severe facial wrinkles and folds, such as nasolabial folds, in adults older than 21 years, the company announced.

In the US pivotal clinical trial, 59% of patients saw improvement in moderate to severe nasolabial folds for up to 18 months, with 82% of patients saying they were very satisfied at 6 months and 68% at 18 months, the company notes in a news release.

"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 from Coral Gables, Florida, said in the release.  

Juvéderm Vollure XC is formulated with proprietary Vycross technology, which blends different molecular weights of hyaluronic acid, contributing to the gel's duration, according to the company.

The most common side effects seen in the clinical study were temporary injection site responses, 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 will be available in the United States in April 2017. The product was first approved in Europe as Juvéderm Volift in 2013.

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