Allergan announced that the Food and Drug Administration (FDA) has approved Juvederm Volbella XC injectable gel for use in lip augmentation and for correction of perioral rhytids (referred to as perioral lines) in adults aged >21 years old.
Juvederm Volbella XC is a soft, smooth gel that combines different molecular weights of hyaluronic acid, contributing to the duration of the gel. It consists of a lower hyaluronic acid concentration (15mg/mL), which adds subtle volume to the lips and softening the appearance of perioral rhytids. It also contains Vycross, a proprietary filler technology designed to address specific patient concerns such as lip fullness, age-related volume loss in the cheek area, or perioral rhytids. Juvederm Voluma XC, which also features Vycross technology, was FDA-approved in 2013 for age-related mid-face volume loss.
The safety and efficacy of Juvederm Volbella XC was demonstrated in clinical studies, including one U.S. study (n=168) where the efficacy of Juvederm Volbella XC was evaluated for lip fullness (5-point scale) and smoothness of the lines around the mouth (4-point scale). About two-thirds of the patients treated with Juvederm Volbella XC showed improvement in lip fullness and perioral lines through 1 year. In addition, its safety profile was shown to be similar to that of the control group.
Juvederm Volbella XC will be available starting October 2016.
For more information call (800) 433-8871 or visit Juvederm.com.