FDA approves 12-month labeling for Evolence collagen-based facial filler

Herzliya, Israel and Skillman, NJ (June 8, 2009) /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, a collagen-based dermal filler for the correction of moderate to deep facial wrinkles and folds, such as nasolabial folds.

Today's announcement resulted from an FDA review of additional clinical data that demonstrated safety and efficacy of EVOLENCE for treatment of moderate to deep facial wrinkles through one year1. EVOLENCE is the first and only collagen dermal filler recognized to provide results through 12 months after an initial treatment.

EVOLENCE, 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® 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® represents the next generation facial filler, an innovative structural agent that replaces the collagen we lose over time with all-natural collagen. We are confident that the 12-month duration of EVOLENCE positions it as a preferred choice within dermal filler options for both aesthetic health professionals and patients."

EVOLENCE represents a breakthrough in aesthetics. As one of nature's most fundamental and abundant building blocks, collagen comprises up to 80 percent of the dermis and it helps maintain skin strength, structure and support. Collagen naturally breaks down as a person ages, leading to the appearance of wrinkles, lines and folds.

EVOLENCE, and its proprietary GLYMATRIX Technology, uses naturally sourced collagen to replace the body's lost collagen, adding volume and structural support in depleted areas, for a more naturally youthful appearance. In addition, no pre-test is needed, and GLYMATRIX Technology delivers longer-lasting durability than previous collagen dermal fillers.

Results are visible and immediate at the time of treatment, with minimal to no bruising or swelling, allowing physician and patient to gauge the amount of wrinkle correction with more precision.