FDA approves Allergan's new Juvederm formulation
Allergan has announced that FDA has approved Juvederm XC, a new formulation of the currently FDA-app
The company claims that Juvederm is the first and only hyaluronic acid dermal filler approved by the FDA to last up to one year from initial treatment.
Juvederm XC formulation with 0.3 per cent preservative-free lidocaine, numbs the treatment area within seconds, potentially reducing the need for an additional anesthetic. Juvederm XC provides the same long-lasting results as demonstrated with existing formulations of Juvederm, and now offers a more comfortable injection experience and potentially less time spent in the physician's office compared to the non-lidocaine Juvederm formulation, said the company.
The FDA approval of Juvederm XC was based on data from a multicenter, double-blind, randomized clinical trial. A total of 72 subjects were followed for two weeks after treatment with one of two Juvederm formulations (Juvederm XC with lidocaine or Juvederm without lidocaine) in each nasolabial fold. In the clinical study (n=72), 93 per cent of patients reported less pain when treated with the new formulation of Juvederm compared to those treated with the non-lidocaine formulation of Juvederm. Juvederm XC was found to be more effective in reducing procedural pain during correction of facial wrinkles and folds, while maintaining a similar safety and effectiveness profile to the non-lidocaine formulation of Juvederm.
Robert Grant, corporate vice president of Allergan and president of Allergan Medical, said: "We lead innovation in the dermal filler category with the first and only smooth-consistency gel hyaluronic acid dermal filler approved by the FDA to last up to a year. Now we have added lidocaine to Juvederm to provide the same smooth, long-lasting result, but with additional comfort for patients."