Allergan Aesthetics announced the U.S. FDA approval of JUVEDERM VOLUMA XC for injection in the temple region to improve moderate to severe temple hollowing in adults over the age of 21. JUVEDERM VOLUMA XC is the first and only hyaluronic acid (HA) dermal filler to receive U.S. FDA approval for the improvement of moderate to severe temple hollowing with results lasting up to 13 months with optimal treatment. 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% 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%). Additionally, more than 85% 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% of subjects reported satisfaction with how fresh their face looked, while 73% reported satisfaction with how rested their face appeared three months after treatment.

Additionally, upwards of 80% of subjects were satisfied with how youthful their temples made them look and how well the shape of their temperatures 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 JUVÉDERM VOLUMA XC, and as such, Allergan Aesthetics anticipates that treatment in the temples with JUVÉDERM VOLUMA XC will be available towards the end of this year. In a randomized, controlled, multicenter clinical study to evaluate the safety and effectiveness of JUVÉDERM VOLUMA XC for correction of temple hollowing, 112 subjects were randomized to a treatment group and received injections in the temple area during the primary phase of the study; 58 subjects were randomized to a no-treatment control group. Touch-up treatments occurred approximately 30 days after initial injection, if needed.

After the three-month blinded "no treatment" control period, control subjects were offered treatment; 53 control subjects elected to receive treatment. A total of 40 treatment-group subjects opted for the optional maintenance treatment, which was offered to the treatment group 13 months after the last treatment. Subjects used electronic diaries to record specific signs and symptoms of treatment site responses (TSR) experienced during the first 14 days after the initial touch-up and maintenance treatments.

Subjects in the initial treatment group continued to use the electronic diary on even-numbered days from day 16 to day 30 to record specific signs and symptoms of TSRs. Subjects rated each TSR listed on the diary as "Mild (barely noticeable)," "Moderate (uncomfortable)," "Severe (severe discomfort)," or "None." JUVÉDERM VOLUMA XC, one of six specifically designed products in the JUVÉDERM Collection of Fillers, is currently also indicated for deep (subcutaneous and/or supraperiosteal) injection for cheek augmentation to correct age-related volume loss in the mid-face, and for augmentation of the chin region to improve the chin profile.