Allergan Aesthetics announced the US Food and Drug Administration has approved the hyaluronic acid filler for jawline definition improvement.
Allergan Aesthetics, an AbbVie company, has announced the US Food and Drug Administration (FDA) has approved JUVÉDERM VOLUX XC (hyaluronic acid filler) for the improvement in jawline definition in patients 21 years and older with moderate to severe loss of jawline definition.1
This approval marks the first and only hyaluronic acid filler approved by the FDA for the improvement in jawline definition.
"The approval of JUVÉDERM VOLUX XC represents the largest leap in innovation for our U.S. HA portfolio since the introduction of JUVÉDERM VOLUMA XC," said Carrie Strom, president of Global Allergan Aesthetics and senior vice president of AbbVie. "JUVÉDERM VOLUX XC complements our existing product line to provide even more structure, cohesivity, and lift capacity to create an improved jawline that appears more defined in real life and on camera. JUVÉDERM VOLUX XC is what our providers have been asking for to deliver the jaw-dropping results their patients are seeking."
The approval decision was based upon positive data from a pivotal clinical study. In the study, JUVÉDERM VOLUX XC was found to improve jawline definition (69.9%, 102/146) at 6 months. Additionally, most study participants reported satisfaction with the appearance of their lower face and jawline through 12 months following treatment ( 82.3%, 116/141).
Also, at 6 months, 81.5% (119/146) of participants were satisfied with how well-defined their jawline appeared vs 12.2% (19/156) at baseline. At 6 months, 70.5% (103/146) of participants were satisfied with the smoothness of their lower face, including no fatty folds of skin or jowls, vs 7.7% (12/156) at baseline. Meanwhile, 73.1% (106/145) of participants at 6 months reported being satisfied with how their lower face appeared vs 9.0% (14/156) at baseline.
"Requests for treatment in the lower facial region transcend age, gender, race, and ethnicity in my practice. As people age, many factors can contribute to how the lower face changes, such as genetics and soft tissue loss," said Jeremy Green, MD, a fellowship-trained board-certified Miami cosmetic dermatologist and pivotal clinical trial investigator. "This can cause reduced definition around the jawline area that may impact and change the shape of the face and lead to the appearance of jowls. Clinical trial participants reported high satisfaction with the results of their treatment. In fact, at 6 months post-treatment, 89.7% (131/146) 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%, 123/141). I am excited to now be able to offer this treatment option to all of my patients seeking an improved jawline."
The most commonly reported adverse events included tenderness, pain, swelling, lumps/bumps, firmness, redness, itching, discoloration, and bruising at the injection sites, according to the participants' 30-day daily diaries.
The adverse events were consistent with typical hyaluronic acid injection and were mild or moderate in nature, with most adverse events subsiding after 2 weeks.
1. FDA approves JUVÉDERM VOLUX XC for improvement of jawline definition. AbbVie. August 3, 2022. Accessed August 3, 2022. https://news.abbvie.com/news/press-releases/fda-approves-juvderm-volux-xc-for-improvement-jawline-definition.htm?view_id=5591