The Food and Drug Administration (FDA) has approved Juvéderm® Volux XC for the improvement of jawline definition in patients over 21 years of age with moderate to severe loss of jawline definition.

Juvéderm Volux XC is an injectable gel filler containing hyaluronic acid (HA). The approval is supported by data from a pivotal phase 3 study (ClinicalTrials.gov Identifier: NCT03712137) that evaluated the efficacy and safety of Juvéderm Volux XC for restoring jawline definition in adults with moderate to severe loss of jawline definition. Patients received Juvéderm Volux XC injectable gel on day 1 with an optional maintenance treatment at month 12.

Findings showed that 69.9% (n=102/146) of patients treated with Juvéderm Volux XC had improved jawline definition at 6 months. Moreover, patients treated with Juvéderm Volux XC reported the following using the Satisfaction with Lower Face and Jawline module of the FACE-Q questionnaire:

  • 82.3% (n=116/141) reported satisfaction with the appearance of their lower face and jawline through 12 months;
  • 81.5% (n=119/146) were satisfied with how sculpted their jawline looked at 6 months vs 12.2% (n=19/156) at baseline;
  • 70.5% (n=103/146) were satisfied with how smooth their lower face looked (eg, no jowls or folds of fatty skin) at 6 months vs 7.7% (n=12/156) at baseline;
  • 73.1% (n=106/145) were satisfied with how nice their lower face looked at 6 months vs 9.0% (n=14/156) at baseline.

“Clinical trial participants reported high satisfaction with the results of their treatment,” said Dr Jeremy Green, a fellowship-trained board-certified Miami cosmetic dermatologist and pivotal clinical trial investigator. “In fact, at 6 months post treatment, 89.7% of treatment group participants were willing to recommend the treatment to a friend, with the majority continuing to recommend treatment at 12 months (87.2%).”

The most common adverse reactions with Juvéderm Volux XC included tenderness, lumps/bumps, pain, swelling, firmness, bruising, redness, itching, and discoloration at the injection sites as reported in patient daily diaries.

Allergan Medical Institute will begin providing Juvéderm Volux XC training in the fall of 2022.

Reference

FDA approves Juvéderm® Volux™ XC for improvement of jawline definition. News release. Allergan Aesthetics. Accessed August 3, 2022. https://www.prnewswire.com/news-releases/fda-approves-juvederm-volux-xc-for-improvement-of-jawline-definition-301598563.html