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FDA Approves Juvederm as the First and Only Hyaluronic Acid Dermal Filler for Use in Moderate to Severe Temple Hollowing

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The approval also marks the first and only approved HA dermal filler approved in the US for use in the upper face.

Calin/Adobe Stock
Calin/Adobe Stock

The US Food and Drug Administration (FDA) has approved the first and only hyaluronic acid dermal filler for use in the upper face. Allergan Aesthetics' Juvéderm Voluma XC is now approved for the improvement of moderate to severe temple hollows in adult patients aged 21 years and older.1

The approval follows positive clinical study data, in which significant portions of patients achieved clinical improvements and reported overall satisfaction with treatment.1

In the randomized, controlled, multi-center clinical study, 112 patients were randomized to a treatment group and received injections in the temple area, while 58 patients were assigned to control group without treatment. At the conclusion of the no-treatment control period, when offered treatment, 53 control patients opted to receive treatment, and 40 treatment group patients opted to receive maintenance treatment.2

After an initial treatment, 59% of patients reported at least one treatment site response (TSR), with 70.5% of patients reporting these TSRs as mild or moderate in nature, and 60% reported the resolution of all TSRs within 3 days.2

More than 80% of patients receiving treatment with Juvéderm Voluma XC had experienced a minimum 1-point improvement in the severity of temple hollowing following 3 months of treatment. This improvement lasted for more than 1 year in 73% of patients, with more than 85% of patients reporting satisfaction with the appearance of their face 3 months post-treatment.2

"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 of Allergan Aesthetics and senior vice president of AbbVie, in a news release.1 "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."

Required with the FDA approval for this new indication is a product training program. Allergan Aesthetics is leading a product training program for aesthetic and dermatologic care providers. The program will cover facial anatomy and considerations for patient use, safe injection, and ways to identify and manage potential complications.

"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, a board-certified dermatologist at Audubon Dermatology and clinical trial investigator, in a news release.1

"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," Hooper said.1 "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."

Given the timeline of Allergan Aesthetics' product training program, Allergan anticipates that treatment with Juvéderm Voluma XC for this indication will be available to patients later this year.

Juvéderm Voluma XC is also currently indicated for use in deep injection for cheek augmentation (for the correction of age-related volume loss in the mid-face) and for augmentation of the chin region (for the improvement of the chin profile).

References

  1. Juvéderm Voluma XC for temple hollows receives U.S. FDA approval. News release. 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#:~:text=%22This%20is%20the%20first%20U.S.,real%20unmet%20need%20for%20patients.%22
  2. ClinicalTrials.Gov. A study evaluating Juvéderm Voluma XC injectable gel for correction of temple hollowing in adult participants over 22 years old. Allergan. Accessed March 5, 2024. https://classic.clinicaltrials.gov/ct2/show/NCT04414397
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