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FDA Approves 12-Month Labeling Update for Evolence

FDA Approves 12-Month Labeling Update for Evolence Collagen-Based Facial Filler

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, 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 year(1). 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(TM) 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(TM) 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.

About Evolence

Evolence is an advanced collagen-based structural dermal filler that provides long-lasting treatment of moderate to deep facial wrinkles and folds, such as nasolabial folds. The results of treatment with Evolence are immediate, with little to no downtime post-treatment and clinically proven to last through 12 months after initial treatment*.

Unlike other dermal fillers that use hyaluronic acid (HA), which absorb water to create their effect, Evolence is a true structural agent due to its three-dimensional collagen matrix. This collagen structure benefits patients as it is directly linked to the minimal bruising and swelling that might result. Evolence does not use chemicals for cross-linking like many other products do, but instead uses natural sugar to improve durability. Evolence collagen is cross-linked through its patented GLYMATRIX(TM) Technology using the natural sugar, D-Ribose. The GLYMATRIX(TM) process is designed to:

The naturally sourced porcine collagen used in Evolence is the most genetically similar to human collagen and has been used safely and effectively for decades in various medical applications, including heart valve replacement.

This new generation collagen filler is intended for injection into the mid-to-deep dermis for the correction of moderate to deep facial wrinkles and folds, such as nasolabial folds. The most common side effects of Evolence injections are usually injection-site related and include mild swelling, redness, and pain. Other rare side effects include the development of small areas of firmness under the skin at the treated sites that may be noticed when the areas are pressed upon.

Evolence has undergone rigorous testing and has been demonstrated to be safe and effective through clinical studies. For more information on the product, visit www.evolence.com.

(1) "Twelve-Month Persistency of a Novel Ribose-Cross-linked Collagen Dermal Filler," Narins, R. et. al., Dermatol Surg 2008; 34; S31-S39

* Initial treatment is defined as a single treatment with the option of touch-up within two to three weeks to achieve optimal correction.

About Ortho Dermatologics

Evolence is marketed in the United States by Ortho Dermatologics division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. This innovative collagen structural dermal filler was developed by ColBar LifeScience Ltd., a biotechnology company specializing in reconstructive medicine and tissue engineering. The company has perfected a technique in which collagen, a main building block of living organisms, can be purified and transformed so as to create a variety of products that are structurally stable and safe for medical applications. ColBar LifeScience Ltd. is a subsidiary of Ortho-McNeil-Janssen Pharmaceuticals, Inc.

Posted: June 2009

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