Inamed's Phase 3 Study Results for Juvederm(TM) to Be Presented at the 64th Annual Meeting of the American Academy of Dermatology.SANTA BARBARA, Calif. -- Key Phase 3 Study Results for Three Juvederm(TM) Formulations to Be Highlighted; Data Shows Superior Efficacy and Duration of Effect Versus Zyplast(R)
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IMDC Isolated, Missing, Detained, or Captured (personnel recovery) ) announced today that Phase 3 clinical data for the three formulations of Juvederm(TM) (Juvederm(TM) 24HV, Juvederm(TM) 30HV, and Juvederm(TM) 30), a next generation, non-animal, cross linked hyaluronic acid hyaluronic acid: see mucopolysaccharide.
A polysaccharide which is an integral part of the gel-like substance of animal connective tissue; it supposedly serves as a lubricant and shock absorbent in the joints. based dermal dermal /der·mal/ (der´mal) pertaining to the dermis or to the skin.
der·mal or der·mic
Of or relating to the skin or dermis. filler, will be presented at the 64th Annual Meeting of the American Academy of Dermatology The American Academy of Dermatology (AAD) is the largest organization of dermatologists in the world.
The Academy grants Fellowships and Associate Memberships, as well as Fellowships for Nonresidents (of the United States of America or Canada). in San Francisco, California “San Francisco” redirects here. For other uses, see San Francisco (disambiguation).
The City and County of San Francisco (EN IPA: [sænfrənˈsɪskoʊ] .
The Juvederm Phase 3 data, which shows superior efficacy and duration of effect versus Zyplast(R) (cross-linked bovine collagen), will be presented today by Gary Monheit, M.D., Associate Clinical Professor of Dermatology and Ophthalmology, University of Alabama at Birmingham UAB began in 1936 as the Birmingham Extension Center of the University of Alabama. Because of the rapid growth of the Birmingham area, it was decided that an extension program for students who had difficulties which prevented them from studying in Tuscaloosa was needed. and President of the American Society for Dermatologic Surgery, and will also be displayed at the poster exhibit at the Moscone Convention Center beginning at 1:00 p.m. on Friday, March 3.
Based on the independent investigators' assessments, the percent of patients improved with Juvederm at 6 months was in the range of 81% - 90% vs. 36% - 45% for Zyplast. At 6 months, patient preference for Juvederm over Zyplast was in the 78% - 88% range. There were no meaningful differences in reported adverse events between Juvederm and Zyplast. Most adverse events reported were mild or moderate in nature and temporary, lasting less then 7 days.
"We are excited about the results of the Phase 3 clinical trial phase 3 clinical trial Phase 3 study. See Phase study. ," said Hani Zeini, Executive Vice President - Inamed Aesthetics. "The Juvederm family of products is an important strategic advance in our facial aesthetics portfolio."
"The data underscore the benefit of adding a new generation of dermal filler to the current aesthetic treatments offered by physicians to patients," said Dr. Monheit. "The superior duration of effect and high patient satisfaction of the family of Juvederm products is an important advancement in the treatment of facial wrinkles."
The Company announced in the fourth quarter 2005 the submission of its Pre-market Approval Application (PMA PMA (papillary-marginal-attached),
n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation.
PMA Progressive muscular atrophy ) to the Food and Drug Administration. Inamed has an exclusive licensing agreement with the Corneal corneal
pertaining to the cornea. See also keratitis, keratopathy.
includes microcornea, coloboma, megalocornea, dermoid, congenital opacity.
corneal black body
see corneal sequestrum (below). Group for the Juvederm family of products and future product line extensions Product line Extensions and Patient safety
In a world of product line extensions, there are many different products with similar names. Examples of these include oxycodone versus oxycontin (oycodone CR), buproprion vs buprion SR vs bruproprion XL, codeine versus codeine contin in the US, Canada, and Australia and a non-exclusive agreement in certain strategically important European markets under the name HydraFill(TM).
About Inamed Corporation
Inamed is a global healthcare company with over 25 years of experience developing, manufacturing and marketing innovative, high-quality, science-based products. Current products include breast implants for aesthetic augmentation and for reconstructive surgery; a range of dermal products to treat facial wrinkles; and minimally invasive devices for obesity intervention, including the Lap-Band System for morbid obesity. The company's website is www.inamed.com.
This press release contains forward-looking statements as of March 3, 2006, including statements regarding certain clinical results of Juvederm(TM) and the development and growth of Inamed's product portfolios. These statements are based on the current intentions, beliefs and expectations of Inamed, but are subject to risks and uncertainties that could cause actual results to differ materially from those projected in these forward-looking statements. These risks and uncertainties include, among others, the results of research and development and business development activities, competition from existing and/or new products, market acceptance of the company's products, the ability to manufacture or otherwise source product to meet market demand, the content and timing of decisions by the FDA FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. , and the factors discussed under the caption "Risks and Uncertainties" in Inamed's Annual Report on Form 10-K for the year ended December 31, 2004. We caution investors not to place undue reliance on the forward-looking statements contained in this press release. These statements speak only as of the date of this press release and Inamed does not undertake any obligation to update or revise the statements. By disclosing any information in this press release, Inamed is not acknowledging that such disclosure is required by law or that such information is material.
Juvederm(TM) is a trademark of Laboratoires D'esthetique Appliquee Corporation, a member of the Corneal Group. Zyplast(R) is a registered trademark of Inamed Corporation. All rights reserved.