Allergan, Inc announced the US Food and Drug Administration's (FDA) approval of Juvederm XC, a new formulation of the currently US FDA-approved Juvederm dermal filler and the latest advancement in hyaluronic acid (HA) dermal fillers. Allergan's new Juvederm formulation contains the local anaesthetic lidocaine to provide patients with enhanced comfort during treatment of moderate to severe facial wrinkles and folds, such as the nasolabial folds (or "parentheses") that appear around the nose and mouth. Juvederm is the first and only hyaluronic acid dermal filler approved by the US FDA to last up to one year from initial treatment and number-one selling hyaluronic acid dermal filler.

"As the global leader in medical aesthetics, Allergan is committed to providing the latest scientific advancements in facial aesthetic products to meet patients' demands and further optimize their experiences," said Robert Grant, Allergan's corporate vice president and president, Allergan Medical. "We lead innovation in the dermal filler category with the first and only smooth-consistency gel hyaluronic acid dermal filler approved by the US FDA to last up to a year. Now we have added lidocaine to Juvederm to provide the same smooth, long-lasting result, but with additional comfort for patients."

The Juvederm XC formulation with 0.3 per cent preservative-free lidocaine numbs the treatment area within seconds, potentially reducing the need for an additional anesthetic. Juvederm XC provides the same smooth, long-lasting results as demonstrated with existing formulations of Juvederm, and now offers a more comfortable injection experience and potentially less time spent in the physician's office when compared to the non-lidocaine Juvederm formulation.

"Patients want a smooth and natural-looking result from a dermal filler treatment, but as a physician I am also interested in managing my patient's discomfort during the injection. Before the introduction of Juvederm XC it often took up to 30 minutes for an anaesthetic block to take effect. In the clinical trial leading up to the US FDA approval, patients reported they experienced less pain with Juvederm XC, compared to their previous dermal filler treatment without lidocaine. So with the new formulation, patients can receive the same smooth results as demonstrated with Juvederm but enjoy a more comfortable injection experience," said Charles Boyd, Boyd Cosmetic Surgical Institute and Juvederm XC clinical investigator.

The US FDA approval of Juvederm XC was based on data from a multicenter, double-blind, randomized clinical trial. A total of 72 subjects were followed for two weeks after treatment with one of two Juvederm formulations Juvederm XC with lidocaine or Juvederm without lidocaine) in each nasolabial fold. In the clinical study (n=72), 93 per cent of patients reported less pain when treated with the new formulation of Juvederm compared to those treated with the non-lidocaine formulation of Juvederm. Juvederm XC was found to be more effective in reducing procedural pain during correction of facial wrinkles and folds while maintaining a similar safety and effectiveness profile to the non-lidocaine formulation of Juvederm.

Following US FDA's approval, the new formulation of Juvederm with lidocaine is available for ordering nationwide. Juvederm is a prescription-only treatment and should be administered by a qualified medical practitioner who has been trained in Juvederm injection techniques.

Founded in 1950, Allergan, Inc., with headquarters in Irvine, California, is a multi-specialty health care company that discovers, develops and commercializes innovative pharmaceuticals, biologics and medical devices that enable people to live life to its greatest potential - to see more clearly, move more freely, express themselves more fully.