Photos: FDA Approves 12-Month Labeling Update for EVOLENCE(R) Collagen-Based Fac...( First and Only Collagen-Based Filler ...)

First and Only Collagen-Based Filler Proven To Last Through One Year

HERZLIYA, Israel and SKILLMAN, N.J., June 8 /PRNewswire/ -- Ortho Dermatologics today announced that the U.S. Food and Drug Administration (FDA) approved a labeling supplement which includes efficacy and safety data through 12 months for EVOLENCE(R), a collagen-based dermal filler for the correction of moderate to deep facial wrinkles and folds, such as nasolabial folds.

To view the Multimedia News Release, go to: http://www.prnewswire.com/mnr/evolence/37751/

(Photo: http://www.newscom.com/cgi-bin/prnh/20090608/NY21855 )

Today's announcement resulted from an FDA review of additional clinical data that demonstrated safety and efficacy of EVOLENCE(R) for treatment of moderate to deep facial wrinkles through one year(1). EVOLENCE(R) is the first and only collagen dermal filler recognized to provide results through 12 months after an initial treatment*.

EVOLENCE(R), the first dermal filler entry for Ortho Dermatologics, was introduced in the US in 2008 with a six-month duration labeling. While relatively new to the United States, EVOLENCE(R) has been approved in Canada, Western and Eastern Europe, Israel, South Korea and Russia since 2004/2005 and has been cleared for 12-month duration in those countries.

"Physicians can now offer patients an all-natural dermal filler that provides beautiful and immediate results for significantly longer than any other collagen dermal filler," said Annie Heremans, M.D., Ph.D., Vice President, responsible for the Company's research and development of the Medical and Aesthetic Dermatology franchises. "EVOLENCE(R) represents the next generation facial filler, an innovative structural agent that replaces the coll
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