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• Belotero® Balance Dermal Filler Close to FDA Approval

  By Dr. Jeffrey J. Roth Sun, October 03, 2010 3:08 pm MDT

  Belotero® Balance, manufactured by Merz Pharmaceuticals, LLC,  may be the next hyaluronic acid (HA) dermal filler on the market for cosmetic treatment for wrinkles and lines or folds in the skin. Merz is hoping to get FDA approval in September 2010.

  The touted difference between Belotero® Balance and the rest of the HA fillers on the market is  Belotero®'s ability to place HA more superficially in the skin. Belotero® Balance does not seem to have a “Tyndall Effect,” which causes skin that is injected too superficially with dermal fillers to appear slightly bluish, bruised, or as if there are blood vessels on the surface on the skin.  In the past, some superficial HA dermal fillers have caused this appearance but it has not appeared to be an issue with Belotero® Balance in European clinical trials.

  Belotero® Balance is seeking FDA approval for injection into the mid-to-deep dermis for correction of moderate to severe skin wrinkles and folds.

  If Belotero® is approved, it will be interesting to see how it competes with other more established HA fillers in a crowded cosmetic treatment marketplace. If it can distinguish itself, Belotero®  should enjoy the continued explosive growth in the HA filler area of non-operative plastic surgery.

  Jeffrey J. Roth, M.D., F.A.C.S.

  Las Vegas Plastic Surgery

  (702) 450-0777

  www.jjrothmd.com

  References:

  Merz USA

  Plastic Surgery Practice

  Belotero® Balance PMA filing accepted for review by FDA

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