FDA Approves JUVÉDERM VOLUX XC for Jawline Definition
JUVÉDERM VOLUX XC will be more broadly available to consumers in early 2023.
The U.S. FDA has given its nod to JUVÉDERM VOLUX XC for the improvement of jawline definition in adults over the age of 21 with moderate to severe loss of 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, " says Carrie Strom, President, Global Allergan Aesthetics and Senior Vice President, AbbVie, in a news release. "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 of JUVÉDERM VOLUX XC marks the sixth product offering in the lineup alongside JUVÉDERM VOLUMA XC, JUVÉDERM VOLLURE XC, JUVÉDERM Ultra Plus XC, JUVÉDERM Ultra XC, and JUVÉDERM VOLBELLA XC.
In the pivotal clinical study, JUVÉDERM VOLUX XC was found to effectively improve jawline definition (69.9%, 102/146) at six months. Participants reported satisfaction using the Satisfaction with Lower Face and Jawline module of the FACE-Q questionnaire, most treatment group participants (82.3%, 116/141) reported satisfaction with the appearance of their lower face and jawline through 12 months following treatment with JUVÉDERM VOLUX XC. 4 Additionally, 81.5% (119/146) of participants at six months were satisfied with how sculpted (well-defined) their jawline looked compared to 12.2% (19/156) at baseline. At six months, 70.5% (103/146) of participants were satisfied with how smooth their lower face looked (i.e., no jowls or folds of fatty skin) compared to 7.7% (12/156) at baseline and 73.1% (106/145) of participants at six months were satisfied with how nice their lower face looked compared to 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," says Dr. Jeremy Green, 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 six 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."
Commonly reported side effects in the clinical study included tenderness, lumps/bumps, pain, swelling, firmness, bruising, redness, itching, and discoloration at the injection sites, as reported in participants' 30-day daily diaries. These side effects are consistent with HA filler injection and were usually mild (causing little discomfort and no effect on daily activities) or moderate (causing some discomfort and effect on daily activities) in severity. Most of these side effects went away on their own within two weeks. Participants also reported similar side effects after maintenance injection.
Allergan Medical Institute will be providing an in-depth product training program for JUVÉDERM VOLUX XC, which will include facial anatomy, considerations for safe injection in this area, appropriate patient selection, and aseptic technique. Training will begin in fall of 2022.
JUVÉDERM VOLUX XC will be more broadly available to consumers in early 2023.