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FDA OKs Belotero for facial wrinkles, folds

Washington — The Food and Drug Administration has approved the hyaluronic acid-based filler Belotero Balance (Merz Aesthetics) for the correction of moderate-to-severe facial wrinkles and folds, the company announced.

The approval is based on results of a multicenter study involving 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. The patients were evaluated using a five-point wrinkle severity scale ranging in severity from zero (least) to 4. Belotero Balance demonstrated greater reduction in the mean change of the severity scale at all time points and maintained a reduction of more than 1 point at week 24, compared with a 0.5-point reduction for the control.

No serious adverse events were reported. Commonly occurring reactions, such as swelling, bruising and injection-site nodules, were mild to moderate in severity.

The filler also is approved for aesthetic use in the United Kingdom, Germany, Italy, Russia, Austria and Switzerland.

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