© Reuters.
IRVINE, California – Allergan (NYSE:) Aesthetics, an AbbVie (NYSE: NYSE:) company, has received U.S. FDA approval for its JUVÉDERM® VOLUMA® XC product, which will be used in the U.S. region. temple to treat moderate to severe temple emptying in adults over 21 years of age. This is the first FDA-approved hyaluronic acid dermal filler for this specific facial area, with results lasting up to 13 months after optimal treatment.
The clinical study supporting the approval demonstrated significant patient satisfaction: more than 80% of participants noted an improvement of at least one point in temple emptying at three months and satisfaction levels remained high for more than one year. Trial subjects also reported looking, on average, five years younger six months after treatment.
Carrie Strom, president of Allergan Aesthetics, highlighted the approval as evidence of the company's commitment to innovation and patient care. The treatment is designed to add volume to the temple area, creating a more balanced facial appearance.
Dr. Deirdre Hooper, board-certified dermatologist and clinical trial investigator, expressed excitement about upcoming injector training on the use of JUVÉDERM® VOLUMA® XC, which is expected to be available by the end of the year after healthcare providers complete mandatory training. program.
The safety and efficacy of JUVÉDERM® VOLUMA® XC were evaluated in a multicenter, controlled, randomized clinical study. Side effects, such as tenderness and swelling, were mostly mild or moderate and resolved within two to four weeks. The product is also approved for injection into the cheek area to correct age-related volume loss and into the chin region to improve the chin profile.
This approval expands the range of treatments offered by Allergan Aesthetics, with the goal of addressing 90% of the facial area. JUVÉDERM® VOLUMA® XC is part of the JUVÉDERM® filler collection, which includes six products designed for different areas of the face.
The information in this article is based on a press release from Allergan Aesthetics.
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