dermal filler

FDA Approves New HA Filler

New Hyaluronic Acid-Based Filler Coming to U.S.

The United States Food and Drug Administration (FDA) has approved a cross-linked hyaluronic acid dermal filler from Ontario, Canada-based Prollenium Medical Technologies. The soft tissue filler is sold under the brand Revanesse in Canada. At the time of print, Prollenium had not announced a brand name or date of commercial availability in the U.S.

Voluma XC Satisfactory Results Last up to Two Years

Voluma XC Satisfactory Results Last up to Two Years

A multicenter, single-blind randomized, controlled study to examine the efficacy of Juvéderm Voluma XC—an HA filler for the correction of midface volume deficit (MVD)—from the patients’ perspectives has shown high patient satisfaction up to two years following treatment. The study, conducted by Julius Few, MD, et al, included subjects treated at 15 sites in the U.S. and Canada from August 2009 to June 2012.

Botox Plus Filler Offers Longer-Lasting Results in Glabella

A split-face study of 20 patients revealed that combination treatment with botulinum toxins and hyaluronic dermal fillers for forehead and glabella rhytides produced longer-lasting results than treatment with toxins alone. Meghan Dubina, MD, et al, of the Department of Dermatology, Northwestern University, Chicago, injected botulinum toxin alone on one side of the forehead/glabella and hyaluronic acid filler followed by botulinum toxin on the other side.

Suneva Medical Announces Results of Its Pivotal ArteFill Acne Scar Study

Suneva Medical (www.sunevamedical.com), a privately held aesthetics company, has released the initial treatment results from its Pivotal acne scar study evaluating the safety and efficacy of it long-term dermal filler ArteFill to treat acne scars.
The randomized, double-blinded, multi-center, controlled study evaluated subjects to determine the safety and efficacy of ArteFill for the treatment of moderate-to-severe atrophic acne scars.

BELOTERO BALANCE Now Available Nationwide

Practicing physicians in the United States can now purchase BELOTERO BALANCE (www.belotero.com)—the latest HA filler to receive FDA approval. BELOTERO BALANCE was approved by the Food and Drug Administration (www.fda.gov) in November 2011 as a safe solution for the correction of moderate-to-severe facial wrinkles and folds, such as nasolabial folds and perioral lines. This dermal filler joins Merz Aesthetics' existing portfolio of injectable products, including RADIESSE Volumizing Filler and Asclera (polidocanol) Injection.

Pliaglis Topical Anesthetic Heads Back To Market

The United States Food & Drug Administration (www.fda.gov) has accepted a supplemental New Drug Application (sNDA) for review for topical local anesthetic cream Pliaglis. The anesthetic—owned by Nuvo Research and distributed in the U.S. exclusively by Galderma Laboratories, originally received FDA approval in June 2006. Galderma voluntarily pulled the product from the market in 2008, due to manufacturing issues that occurred at a third-party manufacturing facility.

Restylane Becomes First Approved Lip Filler

Restylane Receives FDA Approval for Lip Augmentation

The United States Food and Drug Administration has expanded the approved usage of RESTYLANE Injectable Gel (Medicis Aesthetics) to include lip augmentation. RESTYLANE was previously approved to treat moderate to severe facial wrinkles and nasolabial folds. Its new label will include an indication for submucosal implantation for lip augmentation in patients over the age of 21. In addition, the RESTYLANE package insert will be amended to include both the new indication and results from the clinical trials for lip augmentation.