FDA approves Juvederm Volbella XC as dermal filler- Allergan

Allergan has announced that the company has received approval from the FDA to market Juvederm Volbella XC, for use in the lips for lip augmentation and for correction of perioral rhytids, commonly referred to as perioral lines, in adults over the age of 21.

In clinical trials, Juvederm Volbella XC was found to effectively increase lip fullness and soften the appearance of lines around the mouth in a majority of subjects through one year. The safety and effectiveness of Juvederm Volbella XC has been demonstrated in several clinical trials including the U.S. pivotal study where 168 subjects were treated with Juvederm Volbella XC. A 5-point scale was used to evaluate the effectiveness of the product for lip fullness and a 4-point scale to evaluate the effectiveness of the product for smoothing lines around the mouth. Approximately two-thirds of subjects treated with VOLBELLA XC showed improvement in lip fullness and perioral lines through 1 year. The safety of Juvederm Volbella XC was observed to be similar to that of the control. The most common side effects were temporary responses at the treatment site such as swelling, tenderness, bruising, firmness lumps/bumps, rednesss, pain, discoloration, and itching. Most of these side effects resolved within 30 days.