© Reuters.
IRVINE, Calif. – Allergan (NYSE:) Aesthetics, an AbbVie company (NYSE: NYSE:), has received U.S. FDA approval for its JUVÉDERM® VOLUMA® XC product to be used in the temple region to treat moderate to severe temple hollowing in adults over 21. This marks the first FDA-approved hyaluronic acid dermal filler for this specific facial area, with results lasting up to 13 months post-optimal treatment.
The clinical study supporting the approval demonstrated significant patient satisfaction, with over 80% of participants noting at least a one-point improvement in temple hollowing at the three-month mark, and satisfaction levels remaining high for over a year. Subjects in the trial also reported looking, on average, five years younger six months following 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, a board-certified dermatologist and clinical trial investigator, expressed enthusiasm for the upcoming training of injectors on using JUVÉDERM® VOLUMA® XC, which is expected to be available towards the end of the year after healthcare providers complete a mandatory training program.
The safety and effectiveness of JUVÉDERM® VOLUMA® XC were evaluated in a randomized, controlled, multicenter 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 in the cheek area to correct age-related volume loss and in the chin region to improve the chin profile.
This approval expands the range of treatments offered by Allergan Aesthetics, aiming to address 90% of the facial area. JUVÉDERM® VOLUMA® XC is part of the JUVÉDERM® Collection of Fillers, which includes six products tailored for different areas of the face.
The information in this article is based on a press release statement from Allergan Aesthetics.
InvestingPro Insights
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