Juviderm
Only Hyaluronic Acid Dermal Fillers Approved To Last Up To 1 Year
(IRVINE, Calif., June 26, 2007) – 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™ Ultra and JUVÉDERM™ 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™ 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.”
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 .
Additional information concerning these and other risk factors can be found in press releases issued by Allergan, as well as Allergan's public periodic filings with the Securities and Exchange Commission, including the discussion under the heading “Risk Factors” in Allergan’s 2006 Form 10-K and Allergan’s Form 10-Q for the quarter ended March 30, 2007. Copies of Allergan's press releases and additional information about Allergan is available on the World Wide Web at www.allergan.com or you can contact the Allergan Investor Relations Department by calling 1-714-246-4636.
Chemical Face Peels, Including TCA Peels
There are a variety of chemical facial peels of the market. The most common chemical facial peels include phenol, TCA , and glycolic acid peels. Also, many lasers are available to refreshen the skin and rid the skin of a variety of pigmented skin lesions and fine lines; however, lasers are very expensive and often can go deeper into the skin than is desirable.
For fine wrinkles, blemishes, and pigmentation a TCA peel might work best. This peel is considered a medium-depth peel as apposed to a deep phenol peel. It takes only 20 minutes to apply and causes minimal discomfort to the patient. There is mild stinging for approximately two minutes, and there is even less stinging that lasts up to three to four hours. It takes approximately seven to ten days for the skin to go through its peeling process. Because TCA , or trichloroacetic acid, is a very light peel, there is never any rawness to the skin, and there is only a very superficial peeling of the skin with the skin turning dark and peeling off. When the new skin underneath the peel is present, which is at seven to ten days, the skin looks cleaner, finer, and more aesthetically pleasing with fewer blemishes and fewer fine lines, particularly around the crow’s feet in the lower eyelids and around the mouth area. A TCA peels can be done and repeated every three months because they are very safe and the risk factors exceptionally low. However, a TCA peel should only be done by MDs, particularly physicians or plastic surgeons, who are well-trained in this technique. They should not be, done by nurses or spas because they are not under absolute direct one-on-one observation by a trained plastic surgeon.
Patients are very satisfied with light peels because they get rid of dark circles around the eyes, help the fine lines, and have a high success rate of getting rid of age spots or pigmented lesions that are present throughout the face as one gets older. A TCA peel can also get good results at a fraction of the cost of laser treatments. After the chemical peel is applied, the patient is asked to use ointment, such as Vaseline or Aquaphor Ointment, on the face three times a day for one week until the peeling is complete. They are also to avoid the sun for approximately two weeks and to use sunblock thereafter and a hat for another two to three months. Rarely does a patient need more than two peels if they take good care of their skin, avoid the sun, use a good sunblock, and wear a hat when going out in strong sunlight. A variety of other products can be used following a TCA peel that can help sustain the results of the peel, including glycolic acid products, vitamin C products, bleaching agent products, and a non-irritating sunblock.
