FDA Okays Juvederm Ultra XC for Lip Augmentation

Megan Brooks

Disclosures

October 01, 2015

The US Food and Drug Administration (FDA) has approved Juvederm Ultra XC (Allergan) for injection into the lips and perioral area for lip augmentation in adults older than 21 years, the company announced today. It is a new indication for the filler.

Juvederm Ultra XC is a smooth gel formulation consisting of a modified form of hyaluronic acid plus a small amount of lidocaine to improve the comfort of the injection.

The gel "instantly adds fullness to the lips and is the only dermal filler that has proven results lasting up to one year for lip augmentation," Allergan notes in a news release.

In clinical trials of the gel for lip augmentation, 79% of subjects showed a "meaningful improvement" in lip fullness 3 months after treatment, and more than 78% reported an improvement in their overall satisfaction with the look and feel of their lips 1 year after treatment, the company said.

Juvederm Ultra XC and >Juvederm Ultra Plus XC injectable gels are already FDA-approved for injection into areas of facial tissue where moderate to severe facial wrinkles and folds occur to temporarily add volume to the skin, especially around the nose and mouth.

Juvederm Voluma XC injectable gel is indicated for deep (subcutaneous and/or supraperiosteal) injection for cheek augmentation to correct age-related volume deficit in the midface in adults older than 21 years.

"These products should not be used in patients who have severe allergies, marked by a history of anaphylaxis or history or presence of multiple severe allergies, and should not be used in patients with a history of allergies to gram-positive bacterial proteins or lidocaine," the company notes.

The most commonly reported adverse effects for Juvederm XC injectable gels are temporary injection site redness, swelling, pain/tenderness, firmness, lumps/bumps, bruising, discoloration, and itching.

For Juvederm Ultra XC or Juvederm Ultra Plus XC, these reactions may be mild or moderate in severity, lasting 14 days or less, and for Juvederm Voluma XC, these reactions were predominately moderate in severity, lasting 2 to 4 weeks, the company notes.

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