FDA approves Allergan's JUVÉDERM XC dermal filler

Allergan, Inc. (NYSE:AGN) today announced the U.S. Food and Drug Administration’s (FDA) approval of JUVÉDERM^® XC, a new formulation of the currently FDA-approved JUVÉDERM^® dermal filler and the latest advancement in hyaluronic acid (HA) dermal fillers. Allergan’s new JUVÉDERM^® formulation contains the local anesthetic 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. JUVÉDERM^® is the first and only hyaluronic acid dermal filler approved by the FDA to last up to one year from initial treatment and number-one selling hyaluronic acid dermal filler.

“We lead innovation in the dermal filler category with the first and only smooth-consistency gel hyaluronic acid dermal filler approved by the FDA to last up to a year. Now we have added lidocaine to JUVÉDERM® to provide the same smooth, long-lasting result, but with additional comfort for patients.”

“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 FDA to last up to a year. Now we have added lidocaine to JUVÉDERM^® to provide the same smooth, long-lasting result, but with additional comfort for patients.”

The JUVÉDERM^® XC formulation with 0.3% preservative-free lidocaine numbs the treatment area within seconds, potentially reducing the need for an additional anesthetic. JUVÉDERM^® XC provides the same smooth, long-lasting results as demonstrated with existing formulations of JUVÉDERM^®, and now offers a more comfortable injection experience and potentially less time spent in the physician’s office when compared to the non-lidocaine JUVÉDERM^® 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 JUVÉDERM^® XC it often took up to 30 minutes for an anesthetic block to take effect. In the clinical trial leading up to the FDA approval, patients reported they experienced less pain with JUVÉDERM^® 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 JUVÉDERM^® but enjoy a more comfortable injection experience,” said Charles Boyd, M.D., Boyd Cosmetic Surgical Institute and JUVÉDERM^® XC clinical investigator.

The FDA approval of JUVÉDERM^® 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 JUVÉDERM^® formulations (JUVÉDERM^® XC with lidocaine or JUVÉDERM^® without lidocaine) in each nasolabial fold. In the clinical study>® compared to those treated with the non-lidocaine formulation of JUVÉDERM^®.⁴ JUVÉDERM^® 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 JUVÉDERM^®.

Following FDA’s approval, the new formulation of JUVÉDERM^® with lidocaine is available for ordering nationwide. JUVÉDERM^® is a prescription-only treatment and should be administered by a qualified medical practitioner who has been trained in JUVÉDERM^® injection techniques. To locate a trained medical practitioner in your area, please visit www.Juvederm.com.

Allergan encourages individuals interested in being treated with the JUVÉDERM^® family of products to visit www.Juvederm.com and access the JUVÉDERM^® Online Treatment Visualizer to upload a picture and help visualize how JUVÉDERM^® can potentially smooth away moderate to severe facial wrinkles and folds. This tool is for visualization and illustrative purposes only and is not a substitute for a consultation with a qualified medical practitioner.

JUVÉDERM^® Family of Products

Allergan’s JUVÉDERM^® dermal filler product line includes JUVÉDERM^® Ultra and JUVÉDERM^® Ultra Plus in the United States, providing physicians with the flexibility to tailor each treatment to the particular needs of the patient. Both of these formulations will now be offered with lidocaine under the brand names, JUVÉDERM^® Ultra XC and JUVÉDERM^® Ultra Plus XC. JUVÉDERM^® XC is contraindicated in patients with a history of allergies to lidocaine.