FDA Approves Juvederm Voluma XC for Temple Hollowing Enhancement

Allergan Aesthetics recently received approval from the U.S. Food and Drug Administration (FDA) for the injection of Juvederm Voluma XC in the temple region. This approval is specifically for the enhancement of moderate to severe temple hollowing in adults aged 21 and above. The treatment yields results that can last up to 13 months when administered optimally. "The approval of Juvederm Voluma XC to treat temple hollows further demonstrates Allergan Aesthetics commitment to innovation and addressing patient needs," says Carrie Strom, president of Allergan Aesthetics and senior vice president of AbbVie. "This is the first U.S. FDA approval of a hyaluronic acid dermal filler for use in the upper face and addresses a real unmet need for patients."

Juvederm Voluma XC temporarily adds volume to immediately lift and augment the shape, contour, and structure of the temple, creating a smooth transition from the cheekbone to the forehead, balancing a patient's overall facial shape. In a clinical study, more than 80 percent of subjects had at least a one-point improvement in moderate to severe temple hollowing three months after treatment, and the improvement lasted for more than one year (73 percent). Additionally, more than 85 percent of clinical trial subjects were satisfied with how balanced, well-proportioned, and symmetric their face looked three months after treatment.

In the clinical study, 68 percent of subjects reported satisfaction with how fresh their face looked, while 73 percent reported satisfaction with how rested their face appeared three months after treatment. Additionally, upwards of 80 percent of subjects were satisfied with how youthful their temples made them look and how well the shape of their temples complemented the shape of their face three months after treatment. With this addition, the Allergan Medical Institute (AMI) team can train aesthetic providers on safe and effective treatments using the Allergan Aesthetics portfolio to address 90% of the face.

Per FDA requirement for this new indication, Allergan Aesthetics is providing a product training program for providers, which includes facial anatomy and considerations for patient selection, safe injection in this area, as well as identification and management of potential complications. Successful completion of this training is necessary prior to the administration of Juvederm Voluma XC, and as such, Allergan Aesthetics anticipates that treatment in the temples with Juvederm Voluma XC will be available toward the end of this year.