Merz Aesthetics announced that the FDA has approved Belotero Balance (hyaluronic acid) for the correction of moderate-to-severe facial wrinkles and folds, such as nasolabial folds. The approval of Belotero Balance, a hyaluronic acid-based cohesive gel, was 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 filler and an approved bovine collagen filler for the correction of their moderate-to-severe nasolabial folds. Patients were evaluated using a five-point Wrinkle Severity Scale (WSRS), ranging in severity from least (0) to most (4). Belotero Balance 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).
For more information call (336) 856-2003 or visit www.belotero.com.