New dermal filler gets FDA nod

November 17, 2011
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The U.S. Food and Drug Administration has approved Merz Aesthetics’ Belotero Balance® Dermal Filler for injection into the dermis for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. This product is a hyaluronic-acid-based cohesive gel dermal filler designed to deliver natural-looking results with little recovery time.

This is the second Merz Aesthetics FDA approval in 2011 and is based on 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 and an approved bovine collagen filler for the correction of moderate to severe nasolabial folds.

Patients were evaluated using a 5-point Wrinkle Severity Scale (WSRS), ranging in severity from least (0) to most (4). According to Merz, Belotero Balance demonstrated a 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 were reported for either treatment. Commonly occurring, short-term injection site reactions, including swelling, bruising, and injection site nodules, were mild to moderate in severity. More rare side effects may include swelling that lasts longer and unevenness or firmness in the area injected; as with any injection, there may be a risk of infection.

Belotero Balance Dermal Filler is manufactured by Anteis S.A.