June 26, 2007 source: Allergan |
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Allergan Announces FDA Approval of Label Extensions for Juvéderm™ Ultra and Juvéderm™ Ultra Plus
Only Hyaluronic Acid Dermal Fillers Approved to Last Up to One Year
"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™ Ultra and Juvéderm™ 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 - unlike semi-permanent or permanent products - because they provide a natural look that can be adjusted over time as the face changes." Juvéderm™ Ultra and Juvéderm™ 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 creases 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™ family of products. About the Study The original, pivotal study included 292 subjects who were randomly assigned treatment with Juvéderm™ Ultra and Juvéderm™ Ultra Plus in one nasolabial fold (NLF) and Zyplast® bovine collagen in the other NLF. NLFs were graded on a five-point wrinkle assessment scale (from 0= no wrinkle to 5 - extreme, deep wrinkle with overlapping skin) together with a validated photographic guide. At the six month end of the pivotal trial, the mean improvement was clinically significant (>= - point improvement form baseline) with Juvéderm™ Ultra or Juvéderm™ Ultra Plus treatment - but not with Zyplast®. After completion of the pivotal trial, subjects could return for a complimentary follow-up treatment, at which time their NLF scores were again evaluated. More than three-quarters of JUVÉDERM™ Ultra and JUVÉDERM™ Ultra Plus pivotal study participants (79% and 76%, respectively) returned for repeat treatment. The mean level of improvement remained clinically significant for a large majority of the subjects who returned at 6-9 months as well as for those who returned beyond 9 months (84% and 92% at 6-9 months, and 75% and 81% beyond 9 months with JUVÉDERM™ Ultra and JUVÉDERM™ Ultra Plus, respectively). Additionally, 23 JUVÉDERM™ Ultra Plus subjects returned more than 48 weeks (1 year) after their last injection and of these, 78% had maintained improvement. A subset of 48 subjects were then enrolled in a second study that followed subjects for 6-12 months after repeat treatment. Throughout the year-long follow-up period, JUVÉDERM™ Ultra and JUVÉDERM™ Ultra Plus provided clinically significant improvement in NLF severity, with a large majority of subjects demonstrating improvement at 6 months and beyond. At 6 months after repeat treatment, 87% of subjects treated with JUVÉDERM™ Ultra and 91% of subjects treated with JUVÉDERM™ Ultra Plus had maintained improvement. At 1 year after repeat treatment, 78% of JUVÉDERM™ Ultra subjects and 90% of JUVÉDERM™ Ultra Plus subjects had maintained improvement. During the studies, no subjects discontinued treatment due to lack of effectiveness or adverse events and no serious treatment-related adverse events were reported with any of the fillers. The frequency and severity of treatment site reactions was similar for all the fillers, with the majority of treatment site reactions lasting seven days or less. There were no treatment-related adverse events other than those localized to the area of injection and in general site reactions were mild or moderate in severity and did not require intervention. This study was sponsored by Allergan. Important JUVÉDERM™ Dermal Filler Safety Information JUVÉDERM™ is indicated for injection into the mid to deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds), and is generally well tolerated. 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. For complete patient safety and prescribing information, please visit www.Juvederm.com. ### |
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