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Merz Aesthetics (Formerly Known as BioForm Medical, Inc.) Announces FDA Approval of Belotero Balance® Dermal Filler for the Correction of Moderate-to-Severe Facial Wrinkles and Folds


11/17/2011 6:29:20 AM

SAN MATEO, Calif., Nov. 16, 2011 /PRNewswire/ -- Merz Aesthetics today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved BELOTERO Balance® for the correction of moderate-to-severe facial wrinkles and folds. BELOTERO Balance® filler is a hyaluronic acid-based cohesive gel dermal filler designed to deliver natural-looking results with little recovery time. BELOTERO® filler is currently approved for aesthetic use in the United Kingdom, Germany, Italy, Russia, Austria and Switzerland.

"BELOTERO Balance® is a soft dermal filler that is designed to achieve meaningful results by integrating into facial skin tissue," said Rhoda S. Narins, M.D., lead investigator and Clinical Professor of Dermatology at New York University Medical School, New York, N.Y. "With BELOTERO Balance®, patients are able to see a visible softening in their lines for a natural look that lasts."

BELOTERO Balance® Dermal Filler is the newest addition to the Merz Aesthetics expanding portfolio of intelligently designed products and the second Merz Aesthetics FDA approval in 2011.

"BELOTERO Balance® Dermal Filler is an important addition to our expanding portfolio of aesthetic products in the United States," said Dennis Condon, President and CEO of Merz Aesthetics, Inc. "The availability of BELOTERO Balance® provides physicians with a new option for patients seeking treatment with a dermal filler."

The FDA approval of BELOTERO Balance® Dermal Filler is based on the results from a randomized, double-blind, active-controlled, multicenter study of 118 patients. In a split face design, patients received bilateral treatment with BELOTERO Balance® filler and an approved bovine collagen (COL) filler for the correction of their moderate-to-severe nasolabial folds (NLFs).

Patients were evaluated using a five-point Wrinkle Severity Scale (WSRS), ranging in severity from least (0) to most (4). BELOTERO Balance® Dermal Filler demonstrated greater reduction in the mean change of the WSRS at all-time points and maintained more than 1 point WSRS reduction at week 24 (compared to 0.5 for the control).

No serious adverse events (AEs) were reported in this study for either treatment. Commonly occurring, short-term injection site reactions, including swelling, bruising and injection site nodules, were mild to moderate in severity.

Important BELOTERO Balance® Dermal Filler Treatment Considerations

BELOTERO Balance® Dermal Filler is FDA-approved for injection into the dermis for the correction of moderate-to-severe facial wrinkles and folds, such as nasolabial folds. After injection, patients may experience redness, bruising, swelling or other local side effects. More rare side effects may include swelling that lasts longer, unevenness or firmness in the area injected, and as with any injection, there may be a risk of infection.

About Merz Aesthetics

Merz Aesthetics, Inc. is a division of German-based Merz Pharmaceuticals. The Merz Aesthetics Business Unit has subsidiaries in 17 countries and cooperates with more than 30 distributors worldwide.

Founded in 1908 by Friedrich Merz, Merz introduced the world's first anti-wrinkle treatment in 1953 after conducting extensive research on the effects of revitalizing skin care essences. As part of the Merz Pharma Group of companies, Merz Aesthetics leverages more than a century of Merz's healthcare expertise with its range of products and unparalleled service to the field of aesthetic dermatology. The Merz legacy continues today with Merz Aesthetics' innovative portfolio of products which are designed to empower consumers to achieve their personalized beauty ideals.

Merz Aesthetics' balanced portfolio of products in the U.S. includes its flagship brand, RADIESSE® Volumizing Filler, as well as other aesthetic products. Outside of the U.S., the Merz Aesthetics' portfolio consists of the BELOTERO® Family of fillers, RADIESSE® Volumizing Filler and other product brands.

BELOTERO Balance® Dermal Filler is manufactured by Anteis S.A.

SOURCE Merz Aesthetics



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