News
Article
Author(s):
Juvéderm Voluma XC (AbbVie) is the first and only hyaluronic acid dermal filler to receive FDA approval for this indication with results lasting up to 13 months.
The FDA has approved Juvéderm Voluma XC (AbbVie) for the injection in the temple region to improve moderate to severe temple hollowing in adults aged 21 years and older, according to a press release from the company. The injection is the first and only hyaluronic acid dermal filler to receive FDA approval for this indication with results lasting up to 13 months.1
Image Credit: Aquir - stock.adobe.com
"The approval of Juvéderm Voluma XC to treat temple hollows further demonstrates Allergan Aesthetics commitment to innovation and addressing patient needs," Carrie Strom, president of Allergan Aesthetics and senior vice president of AbbVie, said in the press release. "This is the first FDA approval of a hyaluronic acid dermal filler for use in the upper face and addresses a real unmet need for patients."1
The injection can temporarily add volume that immediately lifts and changes the shape, contour, and structure of the temple, according to the press release. This can create a smoother transition from the cheekbone to the forehead.1
Investigators conducted a multicentered clinical trial to evaluate the safety and efficacy of the injection for this indication in 112 individuals who received randomized treatment in the temple area for the primary phase of the study. The treatments included Juvéderm Voluma XC and a no-treatment control group, according to the press release. After 30 days of the initial injection, touch-up treatments occurred as needed.1
After the no treatment period, the individuals were offered the Juvéderm Voluma XC injection, with 53 individuals out of 58 electing to receive the treatment. In the treatment group, 40 opted for optional maintenance treatment, which was offered to the group 13 months after the last treatment, according to the press release. Individuals also used electronic diaries to record signs and symptoms of treatment response that they experienced during the first 14 days after the initial touch-up and maintenance treatment. They continued to use the diary on even number days from day 16 to 30 to record signs and symptoms, rated as mild (barely noticeable), moderate (uncomfortable), severe (severe discomfort), and none.1
In the clinical study, the results showed that more than 80% of individuals had at least 1-point improvement in moderate to severe temple hallowing 3 months after treatment and 73% had improvements for more than 1 year. Further, 85% were satisfied with the balance, proportion, and symmetry of their face 3 months post-treatment, according to the press release.1
Additionally, 68% of individuals were satisfied with “how fresh” their face looked and 73% were satisfied with how rested their face appeared at 3 months. The results also showed that 80% were satisfied with how youthful their temples made them look and how the shape complimented their face 3 months post-treatment, according to the press release.1
After initial treatment, 59% of individuals reported at least 1 treatment specific reaction, with 70.5% rating it as mild or moderate (26.3%). The results also showed that 60% of reactions were resolved in 3 days, and the incidence was lower than initial treatment for touch-up and maintenance.1
In May 2023, the injection was also approved to improve skin smoothness of the cheeks in adults aged 21 years and older, according to an article on Pharmacy Times.2
