FDA Approves AbbVie’s Juvederm Voluma XC for the Treatment of Moderate to Severe Temple Hollowing

Image Credit: Adobe Stock Images/Leo

Allergan Aesthetics, an AbbVie company, announced that the FDA has approved Juvéderm Voluma XC to treat moderate to severe temple hollowing in adults over 21 years of age. According to the company, the medication has the ability to yield results that last up to 13 months with peak treatment, with approximately 80% of test subjects reporting satisfaction with the outcomes. With this regulatory action, Juvéderm Voluma becomes the first hyaluronic acid (HA) dermal filler indicated for moderate to severe temple hollowing to be approved by the FDA.¹

"The approval of Juvéderm Voluma XC to treat temple hollows further demonstrates Allergan Aesthetics commitment to innovation and addressing patient needs," said Carrie Strom, president, Allergan Aesthetics, SVP, AbbVie, in a press 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."

According to study results, 68% of participants administered Juvéderm Voluma reacted positively to how their faces looked, with 73% expressing approval regarding how rested their faces appeared after three months of treatment. Further, Allergan intends to launch a training program focused on safely using this product, as it is expected to be on the market by the end of 2024.¹

"As an AMI trainer, I am excited to start training injectors on how to use Juvéderm Voluma XC to help address moderate to severe temple hollowing while reinforcing how treatment in this important area fits into a full-face approach that enhances facial balance (framing) and contour for my patients seeking subtle improvement," said Deirdre Hooper, MD, board-certified dermatologist, Audubon Dermatology, and clinical trial investigator, in the press release. "In the clinical study, we found that patients said they looked an average of five years younger six months after Juvéderm Voluma XC treatment. Additionally, more than 85% of clinical study participants were satisfied with the treatment and would recommend it to a friend more than one year after treatment. Once training is completed, injectors like me will be able to offer patients true pan-facial assessments and treatments for safe, repeatable, and optimal results using the Allergan Aesthetics portfolio of products."

In 2022, the FDA previously approved Juvéderm Voluma XC for treating undereye hollows in adults aged 21 years and over. According to the associated clinical trials, 90% of participants provided positive feedback after one year of treatment. Additionally, 90.1% said they would recommend the treatment to a friend.²

"This additional indication for Juvéderm Volbella XC demonstrates Allergan Aesthetics' continued commitment to innovation. The eye area, including the undereye hollow, is a top concern among patients," said Strom, in a previous press release. “Allergan Aesthetics offers the broadest portfolio of treatment options designed to address the delicate eye area from topical skin care with SkinMedica, to crow's feet lines with Botox Cosmetic (onabotulinumtoxinA) and now, with this approval, the infraorbital hollows, commonly referred to as tear troughs, with Juvéderm Volbella XC."

References

1. JUVÉDERM® VOLUMA® XC For Temple Hollows Receives U.S. FDA Approval. AbbVie. March 5, 2024. Accessed March 5, 2024. https://news.abbvie.com/2024-03-05-JUVEDERM-R-VOLUMA-R-XC-For-Temple-Hollows-Receives-U-S-FDA-Approval

2. FDA Approves JUVÉDERM® VOLBELLA® XC For Undereye Hollows. PR Newswire. February 8, 2022. Accessed March 5, 2024. https://www.prnewswire.com/news-releases/fda-approves-juvederm-volbella-xc-for-undereye-hollows-301477144.html