Source: Allergan, Inc.
June 27, 2007
Only Hyaluronic Acid Dermal Fillers Approved To Last Up To 1 Year
Allergan, Inc. (NYSE: AGN), the maker of BOTOX® Cosmetic (Botulinum Toxin Type A), today announced approval by the U.S. Food and Drug Administration (FDA) of label extensions for Juvéderm® Injectable Gel Ultra and Juvéderm® Injectable Gel Ultra Plus based on new clinical data demonstrating that the effects of both products may last for up to one year, which is longer than reported in clinical studies that supported FDA approval of other hyaluronic acid (HA) dermal fillers.
“Patients are looking for longer-lasting, science-based products that fill in lines, such as the parentheses around the mouth, as part of their overall anti-aging skin care regimen,” said Robert Grant, President of Allergan Medical, a division of Allergan. “We are pleased to provide physicians with the only HA dermal filler products currently approved in the United States to provide smooth, natural looking results lasting up to one year with a single treatment.”
Mark Pinsky, M.D., a West Palm Beach, Fla.-based plastic surgeon and a clinical investigator in the study that supported the label extensions, said, “The results of this study are exciting because they establish Juvéderm® Injectable Gel Ultra and Juvéderm® Injectable Gel Ultra Plus as the only HA dermal fillers approved on the market today to have proven persistence up to one year, which is an important attribute to patients. Most patients and physicians want fillers that are long-lasting and reversible â€“ unlike semi-permanent or permanent products â€“ because they provide a natural look that can be adjusted over time as the face changes.”
Juvéderm® Injectable Gel Ultra and Juvéderm® Injectable Gel Ultra Plus are the only HA dermal fillers developed using the proprietary HYLACROSS™ technology, a technologically advanced manufacturing process that results in a malleable, smooth gel that flows easily into the skin and creates a smooth, natural look and feel. All other HA dermal fillers currently on the market have a granular consistency gel. These granules can be seen under 2.4X magnification as opposed to the smooth consistency gel of the Juvéderm® Injectable Gel family of products.