Allergan plc this week announced the U.S. Food and Drug Administration's (FDA) approval of JUVÉDERM VOLBELLA XC, an injectable gel to plump up lips and reduce the appearance of fine lines that develop around the lips.
"Many of my patients are very bothered by the lines that can appear around the lips, known as perioral rhytids. Additionally, when seeking lip augmentation, patients want a smooth, result that is not drastic," The Center for Dermatology, Cosmetic & Laser Surgery Founder and Clinical Trial Investigator Dr. David E. Bank said. "JUVÉDERM VOLBELLA XC adds fullness to the lips and softens the appearance of the lines around the lips. With JUVÉDERM VOLBELLA XC I am able to subtly enhance my patients' pout."
Several clinical trials revealed the effectiveness of the medication. Approximately two-thirds of the U.S. pivotal study participants showed improvement through the one-year mark. It was approved in Europe in 2011, and is currently distributed in more than 70 countries.
"This approval brings to market a product unlike anything that is currently available in the United States," Allergan Chief Commercial Officer Bill Meury said. "JUVÉDERM VOLBELLA XC is formulated with VYCROSS, a proprietary filler technology from Allergan, which yields smooth products that have been engineered to address specific patient concerns such as lip fullness, age-related volume loss in the cheek area, or perioral rhytids."
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