August 3, 2022

FDA Approves JUVÉDERM® VOLUX™ XC for Improvement of Jawline Definition

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JUVÉDERM® VOLUX™ XC IS THE FIRST AND ONLY HYALURONIC ACID (HA) FILLER TO RECEIVE U.S. FDA APPROVAL FOR IMPROVING JAWLINE DEFINITION

IRVINE, Calif., Aug. 3, 2022 /PRNewswire/ -- Today, Allergan Aesthetics, an AbbVie company (NYSE: ABBV), announced the U.S. FDA approval of JUVÉDERM® VOLUX™ XC for the improvement of jawline definition in adults over the age of 21 with moderate to severe loss of jawline definition. 1

"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, 2" said Carrie Strom, President, Global Allergan Aesthetics and Senior Vice President, 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. 1"

As the category leader, the JUVÉDERM® Collection of Fillers offers the broadest portfolio of specifically designed treatment options, and this latest 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.1-3,5-7

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. 4

"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). 4 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. 1

Allergan Aesthetics is dedicated to training health care providers on safe and effective use of all its products. 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.

For more information on the JUVÉDERM® Collection of Fillers, visit Juvederm.com and follow @JUVÉDERM on Instagram.

Consumers and new patients who receive an aesthetic treatment with a product from the JUVÉDERM® Collection of Fillers can also enroll in Allē, Allergan Aesthetics' loyalty rewards program. Consumers can enroll to unlock access to curated content, exclusive offers, and personalized rewards that can be used for savings on the Allergan Aesthetics portfolio of products and redeemed at a participating provider's office, subject to applicable program terms and conditions. Allē is the first and only loyalty program in the aesthetics market to also offer consumers the ability to earn points on over 40 non-Allergan Aesthetics treatments and brands. To learn more about Allē, visit Alle.com.

About Allergan Aesthetics
At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Our goal is to consistently provide our customers with innovation, education, exceptional service, and a commitment to excellence, all with a personal touch. For more information, visit www.AllerganAesthetics.com.

About AbbVie
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on TwitterFacebookInstagramYouTube and LinkedIn.

JUVÉDERM® Injectable Gel Fillers Important Information

APPROVED USES

JUVÉDERM® VOLUX™ XC injectable gel is for deep injection to improve moderate to severe loss of jawline definition in adults over the age of 21.

JUVÉDERM® VOLUMA® XC injectable gel is for deep injection in the cheek area to correct age-related volume loss and for augmentation of the chin region to improve the chin profile in adults over 21.

JUVÉDERM® VOLLURE® XC, JUVÉDERM® Ultra Plus XC, and JUVÉDERM® Ultra XC injectable gels are for injection into the facial tissue for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. JUVÉDERM® VOLLURE® XC injectable gel is for adults over 21.

JUVÉDERM® Ultra XC injectable gel is also for injection into the lips and perioral area for lip augmentation in adults over 21.

JUVÉDERM® VOLBELLA® XC injectable gel is indicated for injection into the lips for lip augmentation and correction of perioral lines, and for injection into the undereye hollows to improve the appearance of undereye hollows in adults over the age of 21.

IMPORTANT SAFETY INFORMATION

Are there any reasons why I should not receive any JUVÉDERM® formulation?
Do not use these products if you have a history of multiple severe allergies or severe allergic reactions (anaphylaxis), or if you are allergic to lidocaine or the Gram-positive bacterial proteins used in these products, or if you have had previous allergic reactions to hyaluronic acid fillers.

What warnings should my doctor advise me about?

  • One of the risks with using dermal fillers is the unintentional injection into a blood vessel. The chances of this happening are very small, but if it does happen, the complications can be serious and may be permanent. These complications, which have been reported for facial injections, can include vision abnormalities, blindness, stroke, temporary scabs, or permanent scarring of the skin. Most of these events are irreversible.
  • The use of dermal fillers where skin sores, pimples, rashes, hives, cysts, or infections are present should be postponed, as this may delay healing or make skin problems worse
  • The effectiveness of removal of any dermal filler has not been studied.

What precautions should my doctor advise me about?

  • JUVÉDERM® VOLBELLA® XC should only be injected into undereye hollows by doctors who have completed the necessary training for this treatment area. To find a doctor, visit Juvederm.com/find-a-specialist. Doctors who complete the training will be listed with a symbol
  • The safety of these products for use during pregnancy or while breastfeeding has not been studied
  • The safety of JUVÉDERM® VOLUMA® XC has not been studied in patients under 35 years or over 65 years for cheek augmentation, or under 22 years and over 80 years for chin augmentation. The safety of JUVÉDERM® VOLUX™ XC, JUVÉDERM® VOLLURE® XC and JUVÉDERM® VOLBELLA® XC has not been studied in patients under 22 years, and the safety of JUVÉDERM® Ultra Plus XC and JUVÉDERM® Ultra XC has not been studied in patients under 18 years
  • The safety and effectiveness of treatment with JUVÉDERM® products in anatomical regions outside of their approved uses have not been established in clinical studies
  • If you have a history of excessive scarring (thick, hard scars) or pigmentation disorders, treatment in these patients has not been studied and may result in additional scars or changes in pigmentation
  • If you are planning other procedures including laser treatments or a chemical peel, there is a possible risk of inflammation at the treatment site if these procedures are performed closely before or after JUVÉDERM® injectable gel treatment
  • Tell your doctor if you are on therapy used to reduce your body's natural defense system (such as steroids, chemotherapy, and medicines to treat autoimmune diseases, HIV, and AIDs), as these may increase your risk of infection; and medications that can prolong bleeding (such as aspirin, ibuprofen, or other blood thinners), as these may result in increased bruising or bleeding at the injection site
  • Minimize strenuous exercise, exposure to extensive sun or heat, and alcoholic beverages within the first 24 hours following treatment, as these may cause temporary redness, swelling, and/or itching at the injection site
  • JUVÉDERM® VOLUMA® XC was not studied in patients with significant loose skin of the chin, neck, or jaw
  • The effect of JUVÉDERM® VOLUMA® XC injection into the chin on facial hair growth has not been studied
  • Patients who experience skin injury near the site of JUVÉDERM® VOLUMA® XC injection may be at a higher risk for adverse events
  • Tell your doctor if you have already been injected with dermal fillers in the same area as the one(s) you are about to be treated for. This information helps your doctor decide when and whether you should get treatment

What are possible side effects of treatment?
The most commonly reported side effects with JUVÉDERM® injectable gels were redness, swelling, pain, tenderness, firmness, lumps/bumps, bruising, discoloration, and itching. For JUVÉDERM® VOLBELLA® XC, dryness was also reported. 

These side effects are consistent with other facial injection procedures, and most will resolve with time. Your doctor may choose to treat side effects persisting over 30 days with antibiotics, steroids, or hyaluronidase (an enzyme that breaks down hyaluronic acid).

As with all skin injection procedures, there is a risk of infection.

To report a side effect with any product in the JUVÉDERM® Collection, please call the Allergan® Product Support Department at 1‑877‑345‑5372. Please also visit Juvederm.com or talk to your doctor for more information.

Products in the JUVÉDERM® Collection are available only by a licensed physician or properly licensed practitioner.

References

  1. Allergan Data On File JUVÉDERM® VOLUX™ XC Patient Label 2022
  2. Allergan Data On File JUVÉDERM® VOLUMA® XC Patient Label 2020
  3. Allergan Data On File JUVÉDERM® VOLBELLA® XC Patient Label 2020
  4. Allergan Data On File JUVÉDERM® VOLUX™ XC Directions For Use 2022
  5. Allergan Data On File JUVÉDERM® VOLLURE® XC Patient Label 2020
  6. Allergan Data On File JUVÉDERM® Ultra Plus XC Patient Label 2020
  7. Allergan Data On File JUVÉDERM® Ultra XC Patient Label 2020

 

SOURCE AbbVie

Contact(s)

Contact(s):
Investors
Liz Shea
Liz.Shea@AbbVie.com
(847) 935-2211

Media
Ember Garrett
Ember.Garrett@allergan.com
(714) 246-3525