Allergan plc,, a leading global pharmaceutical company, has received approval from the US 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.
Juvederm Ultra XC 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.
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. 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 per cent of subjects showed a meaningful improvement in lip fullness three months after treatment. Additionally, more than 78 per cent of subjects reported an improvement in their overall satisfaction with the look and feel of their lips at one year after treatment.
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