Juvéderm Volbella XC Approved by FDA for Lip Augmentation and Perioral Rhytids

 

Marketing of Juvéderm Volbella XC for lip augmentation and the correction of perioral rhytids (skin wrinkles) in adults has been approved by the FDA, according to an Allergan press release.

In the majority of participants in clinical trials, Juvéderm Volbella XC (made of hyaluronic acid) gel was shown to increase the fullness of lips and soften the appearance of perioral lines. According to the release, results lasted through one year.

David E. Bank, MD, clinical trial researcher and found of The Center for Dermatology, Cosmetic and Laser Surgery, Mount Kisco, New York, said in the release that many of his patients are very bothered by the lines that can appear around their lips. “Juvéderm Volbella XC adds fullness to the lips and softens the appearance of the lines around the lips. With [the product], I am able to subtly enhance my patients’ pout, ” he said.

Juvéderm Volbella XC is made with Vycross, which blends different molecular weights of hyaluronic acid and can contribute to the length of effectiveness.

According to the release, the product has been customized with a lower concentration of hyaluronic acid (15 mg/mL), allowing for softening the appearance of perioral lines and subtle volume to the lips.

Clinical trials of the product included a study of 168 patients treated with Juvéderm Volbella XC. About two-thirds of patients showed improvement of perioral lines and lip fullness through one full year, says the release. The safety of the product was similar to control. The most common side effects included treatment site bruising, swelling, tenderness, redness, bumps, lumps, itching, and pain. However, most of the symptoms resolved within 30 days.