FDA approves Juvederm Ultra XC for lip augmentation

Allergan announced it has received FDA approval to market Juvederm Ultra XC for injection into the lips and periorial area for lip augmentation in adults aged 21 years and older.

Juvederm Ultra XC, a gel formulation of a modified form of hyaluronic acid, is the only dermal filler with results shown to last up to 1 year for lip augmentation, according to a press release.

“Understanding that the desire for lip augmentation is to achieve a natural-looking and lasting result, we continued our research of Juvederm Ultra XC for lips,” Philippe Schaison, president of Allergan Medical, said in the release.

Participants in clinical trials of Juvederm Ultra XC reported improvement in softness, smoothness and natural look and feel of their lips through 1 year, according to the release. There was a meaningful improvement in lip fullness 3 months after treatment in 79% of patients. At one year after treatment, an improvement in overall satisfaction with the look and feel of their lips was reported by more than 78% of the patients, according to the release.

“When discussing lip treatment with patients, they most often express concerns over being able to achieve a natural-looking result,” Suzanne Kilmer, MD, clinical trial investigator and director of the Laser & Skin Surgery center of Northern California, said in the release. “This is why I am very pleased that Allergan has conducted additional research to achieve FDA approval of Juvederm Ultra XC for this new indication.”

Juvederm Ultra XC also is indicated for injection into areas of facial tissue where moderate-to-severed facial wrinkles and folds occur, especially around the nose and mouth, according to the release.

Contraindications for Juvederm injectable gels include that the product should not be used in patients with severe allergies, including a history of allergies to gram-positive bacterial proteins or lidocaine, according to the release. The release also warned the gel should not be injected into blood vessels, which could lead to embolization, occlusion of the vessels, ischemia or infarction.

Adverse events reported for Juvederm XC injectable gels include temporary site redness, swelling, pain/tenderness, firmness, lumps/bumps, bruising, discoloration and itching. In Juvederm Ultra XC, they were mild to moderate in severity with a duration of 14 days or less, according to the release.

Reference: www.allergan.com