Allergan Announces FDA Approval of Juvederm Gel Family of Products
IRVINE, Calif., June 5, 2006 -- Allergan, Inc. today announced the U.S. Food and Drug Administration (FDA)'s approval of the Juvederm gel family of products, a 'next generation' of hyaluronic acid dermal fillers that provide a smooth, long-lasting correction of facial wrinkles and folds.
Juvederm is natural, biodegradable and currently the only approved hyaluronic acid dermal filler that has demonstrated its safety and effectiveness in patients of all skin types and colors. It also is the only hyaluronic acid dermal filler developed using a proprietary, technologically advanced manufacturing process that results in a malleable smooth gel that flows easily into the skin, creating a smooth, natural look and feel. All other currently approved hyaluronic acid dermal fillers utilize a gel particle suspension formulation.
The Juvederm family of products offers the highest concentration of cross-linked hyaluronic acid available in a dermal filler, which results in a long duration of effect and may be attributed to the majority of patients not requiring touch-ups following their initial treatment. The smooth consistency of the Juvederm formula also may help to minimize the discomfort that can sometimes occur during the injection procedure.
The FDA approved three different formulations for Juvederm providing physicians with the flexibility to tailor each treatment to the particular needs of the patient. The three product formulations include: Juvederm 24HV, a highly cross-linked formulation for more versatility in contouring and volumizing of facial wrinkles and folds; Juvederm 30HV, a more highly cross-linked robust formulation for volumizing and correction of deeper folds and wrinkles; and Juvederm 30, a highly cross-linked formulation for subtle correction of facial wrinkles and folds.
Hyaluronic acid dermal fillers represent the fastest growing non-invasive aesthetic procedure in the United States. Occurring naturally in the body, hyaluronic acid is a natural complex sugar found in all living organisms and creates volume and elasticity in the skin. Juvederm adds volume to facial wrinkles, such as nasolabial folds (the folds running from the sides of the bottom of the nose to the outer corners of the mouth). Hyaluronic acid treats multiple medical conditions, including those associated with the eye and the knee, and has been used for more than 20 years.
Juvederm Clinical Studies
The FDA's approval of Juvederm was based on data from a double-blind, randomized and controlled clinical trial. A total of 439 subjects were followed for six months after injection with one of three Juvederm formulations (Juvederm 24HV, Juvederm 30HV, Juvederm 30) in one nasolabial fold, and Zyplast (bovine-based collagen) in the other.
Juvederm was found to provide a more persistent wrinkle correction than Zyplast over the 6-month course of the study, with up to 90% of subjects maintaining at least a 1-grade improvement in nasolabial fold correction with Juvederm compared to 36-45% with Zyplast. At the conclusion of the study, up to 88% of subjects expressed a preference for Juvederm while only 5-12% expressed a preference for Zyplast. In addition, among non-Caucasian patients (all Fitzpatrick Skin Types), Juvederm was found safe and effective and demonstrated no increased risk of hyperpigmentation or hypertrophic scarring.
Important Juvederm Safety Information
In clinical studies, adverse events were usually mild to moderate in nature, did not require intervention and lasted seven days or less. The most common side effects included temporary injection site reactions including redness, pain/tenderness, firmness, swelling, lumps and bumps and bruising.
Source: Allergan, Inc.
Posted: June 2006