FDA approves Allergan’s Juvederm ultra XC

Allergan plc has announced that the company has received approval from the U.S. Food and Drug Administration (FDA) to market Juvederm ultra XC for injection into the lips and perioral area for lip augmentation in adults over the age of 21.

In annoucement issued on Thursday Allergan says that Juvederm ultra XC instantly adds fullness to the lips and is the only dermal filler that has proven results lasting up to one year for lip augmentation.

“As the leader in medical aesthetics, Allergan is committed to continued research and development in this area,” said Philippe Schaison, Executive Vice President & President, Allergan Medical.

“Providing physicians and patients with premium products that allow them to achieve the aesthetic results they want is always our goal. Understanding that the desire with lip augmentation is to achieve a natural-looking and lasting result, we continued our research of Juvederm ultra XC for the lips. With this approval, Juvederm ultra XC is now the only filler that is approved to last up to one year in the lips while providing natural-looking results.”

Since Juvederm formulations were first approved in the United States in 2006, physicians and patients have relied on them to correct moderate to severe facial wrinkles and folds, such as the parentheses lines around the nose and mouth. This heritage has continued with introduction of Juvederm voluma XC for age-related mid-face volume loss in 2013, and now, with Juvederm ultra XC for lip augmentation, says the company.

Furthermore, in clinical trials of Juvederm ultra XC, the majority of subjects reported improvement in the softness, smoothness and natural look and feel of their lips through one year. In clinical trials, 79% of subjects showed a meaningful improvement in lip fullness three months after treatment. Additionally, more than 78% of subjects reported an improvement in their overall satisfaction with the look and feel of their lips at one year after treatment.

“I often see patients who have thin lips or lips that have become thinner over time. When discussing lip treatment with patients, they most often express concern over being able to achieve a natural-looking result. This is why I am very pleased that Allergan has conducted additional research to receive FDA approval of Juvederm ultra XC for this new indication,” said Dr. Suzanne Kilmer, board certified dermatologist, clinical trial investigator and Director of the Laser & Skin Surgery Center of Northern California.

“Now, physicians and their patients can achieve the natural-looking results they have come to know and expect with Juvederm ultra XC, in the lips.”

Juvederm ultra XC, as Allergen explains, is a smooth gel formulation made up of a modified form of hyaluronic acid (HA), a naturally occurring sugar found in the human body. The role of HA in the skin is to deliver nutrients and help the skin retain its natural moisture and softness. The gel formulation also contains a small amount of local anesthetic (lidocaine), which helps to improve the comfort of the injection.