FDA Approves Juvederm Voluma XC for Temple Hollowing

Allergan Aesthetics has received 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.[1] The injection is the first and only hyaluronic acid (HA) dermal filler to receive FDA approval for the improvement of moderate to severe temple hollowing with results lasting up to 13 months.[1]

"The approval of Juvederm Voluma XC to treat temple hollows further demonstrates Allergan Aesthetics commitment to innovation and addressing patient needs," Carrie Strom, President, Allergan Aesthetics and Senior Vice President, AbbVie, said in a company news release. "This is the first US 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, according to Allergan, which is part of Abbvie. 

In a clinical study, more than 80% of subjects had at least a one-point improvement in moderate to severe temple hollowing 3 months after treatment, and the improvement lasted for more than 1 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.[1] In the study, 68% of subjects reported satisfaction with how fresh their face looked, while 73% reported satisfaction with how rested their face appeared 3 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 temples complemented the shape of their face 3 months after treatment.

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.

Allergan anticipates that treatment in the temples with Juvederm Voluma XC will be available toward the end of this year.

In a randomized, controlled, multicenter clinical study to evaluate the safety and effectiveness of Juvederm 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 3-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.[2]

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."

After initial treatment with Juvederm Voluma XC, 59% of the subjects with diary entries reported experiencing at least one TSR, and 70.5% of subjects rated TSRs as mild or moderate (26.3%) in severity, with a majority (60%) of all reported TSRs resolving within three days. The incidence of TSRs for the touch-up and maintenance treatments was lower than that for initial treatment.

Juvederm Voluma XC, one of six specifically designed products in the Juvederm 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.[3,4]

References

1. JUVÉDERM® VOLUMA® XC Patient Labeling for Temple. 2024.
2. JUVÉDERM® VOLUMA® XC Directions for Use. 2024.
3. JUVÉDERM® VOLUMA® XC Patient Labeling for Cheek. 2019.
4. JUVÉDERM® VOLUMA® XC Patient Labeling for Chin. 2020.