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. FOOD AND DRUG ADMINISTRATION approval of JUVÉDERM ® VOLUX™ XC for the improvement associated with 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 Oughout. S. HA portfolio since the introduction associated with JUVÉDERM ® VOLUMA ® XC, 2 ” said Carrie Strom , President, Global Allergan Appearance 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 own providers have been asking for to deliver the jaw-dropping results their patients are seeking. one inch

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 particular sixth product offering in the lineup alongside JUVÉDERM ® VOLUMA ® XC, JUVÉDERM ® VOLLURE ®   XC, JUVÉDERM ® Ultra Plus XC, JUVÉDERM ® Super XC, plus 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 fulfillment with the appearance of their lower face plus jawline through 12 months following treatment with JUVÉDERM ® VOLUX™ XC. 4 Additionally , 81. 5% (119/146) of participants at six months were satisfied along with how sculpted (well-defined) their own jawline looked compared to 12. 2% (19/156) at baseline. At 6 months, 70. 5% (103/146) of participants were satisfied with how smooth their reduce face appeared (i. e., no jowls or folds of fatty skin) in comparison to 7. 7% (12/156) at baseline and 73. 1% (106/145) associated with participants in six months were satisfied with how nice their particular lower face looked when compared with 9. 0% (14/156) from baseline. four

“Requests for therapy in the particular lower facial region transcend age, gender, race, plus ethnicity within my practice. As people age, many factors can contribute to how the reduced face changes, such as genetics and soft tissue loss, ” says Dr . Jeremy Green , a fellowship-trained board-certified Miami cosmetic dermatologist and crucial clinical trial investigator. “This can cause reduced definition around the jawline area that may impact and change the shape of the encounter and lead to the appearance of jowls. Clinical test participants reported high satisfaction with the results of their treatment. Within fact, with six months post-treatment, 89. 7% (131/146) of treatment group individuals were willing to recommend the therapy to a friend, using the majority continuing in order to recommend treatment at twelve months (87. 2%, 123/141). 4   I am excited to now be able to offer this therapy option to all of my patients seeking an improved jawline. ”

Commonly documented side effects in the clinical study included tenderness, lumps/bumps, pain, swelling, firmness, bruising, redness, itching, and discoloration at the particular 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 every day activities) or moderate (causing some pain and effect on everyday activities) within severity. Most of these side effects went away upon their own within two weeks. Individuals also documented similar negative effects after maintenance injection. 1

Allergan Aesthetics is dedicated in order to training health care providers on safe and effective use of all its products. Allergan Medical Institute will be providing a good in-depth item training program with regard to JUVÉDERM ® VOLUX™ XC, which will include facial anatomy, considerations regarding 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 ® Variety of Injectables, visit Juvederm. com and follow @JUVÉDERM on Instagram.

Consumers plus 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 benefits that can be used intended for savings on the Allergan Aesthetics portfolio of products and redeemed at a participating provider’s office, subject to applicable program terms plus conditions. Allē is the particular first and only loyalty program within 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 Looks
At Allergan Aesthetics, an AbbVie company, we develop, manufacture, plus market a portfolio associated with leading aesthetics brands and products. Our aesthetics profile includes face injectables, body contouring, plastics, skin care, and more. Our own goal will be to consistently provide the customers along with innovation, education, exceptional service, and the commitment to excellence, almost all with a personal touch. With regard to more info, visit  www.AllerganAesthetics.com .

Regarding AbbVie
AbbVie’s mission is usually to discover and provide innovative medicines that solve serious health issues today plus 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 throughout its Allergan Aesthetics portfolio. For a lot more information regarding AbbVie, please visit us at  www.abbvie.com . Follow  @abbvie  on  Twitter ,   Facebook ,   Instagram ,   YouTube   and  LinkedIn .

JUVÉDERM ®   Injectable Gel Fillers Important Information

APPROVED USES

JUVÉDERM ® VOLUX™ XC injectable gel is to get deep shot to improve reasonable to serious lack of jawline definition in adults older than 21.

JUVÉDERM ® VOLUMA ® XC injectable solution is pertaining to deep injection in the cheek area in order to correct age-related volume reduction and meant for augmentation of the chin region to enhance the face profile in adults over twenty one.

JUVÉDERM ®   VOLLURE ® XC, JUVÉDERM ® Ultra Plus XC, plus JUVÉDERM ®   Extremely XC injectable gels are usually for shot into the particular facial tissue for that correction of moderate to severe facial wrinkles and folds up, like nasolabial folds. JUVÉDERM ® VOLLURE ® XC injectable gel is for grown ups over 21.

JUVÉDERM ®   Ultra XC injectable gel is definitely also designed for injection into the lips and perioral area for lip augmentation in grown-ups over twenty one.

JUVÉDERM ®   VOLBELLA ®   XC injectable gel can be indicated just for injection in to the lips for lip augmentation and modification of perioral lines, and for injection  to the undereye hollows to improve the look associated with undereye hollows in adults more than the age of 21.

IMPORTANT SAFETY INFORMATION

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

What warnings ought to my doctor advise me about?

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

Exactly what precautions need to my physician advise me personally about?

  • JUVÉDERM ®   VOLBELLA ®   XC should only be injected into undereye hollows by doctors who have completed the necessary training with regard to this treatment region. To find a doctor, visit Juvederm. com/find-a-specialist . Doctors who complete the training will be listed with a symbol
  • The particular safety of these products for use during pregnancy or while breastfeeding has not been studied
  • The safety of JUVÉDERM ®   VOLUMA ® XC offers not already been studied within patients under 35 years or over 65 years regarding cheek enhancement, or below 22 many years and over 80 years intended for chin augmentation. The safety of JUVÉDERM ® VOLUX™ XC, JUVÉDERM ® VOLLURE ® XC plus JUVÉDERM ®   VOLBELLA ®   XC provides not been studied in patients under 22 yrs, and the security of JUVÉDERM® Ultra In addition XC and JUVÉDERM ®   Super XC has not already been studied within patients below 18 years
  • The protection and usefulness of treatment with JUVÉDERM ®   products in anatomical regions outside of their own approved uses have not been established within clinical studies
  • If you have a history associated with excessive skin damage (thick, hard scars) or pigmentation disorders, treatment in these patients is not studied and may result in additional scars or modifications in pigmentation
  • If you are planning other procedures including laser treatments or even a chemical peel, there is a possible risk of inflammation at the particular treatment site if these types of procedures are performed closely before or after JUVÉDERM ®   injectable gel therapy
  • Tell your doctor if a person are upon therapy used to reduce your body’s natural defense system (such as steroids, chemotherapy, plus medicines to treat autoimmune diseases, HIV, and AIDs), as these may increase your danger of infection; and medications that may prolong bleeding (such as aspirin, ibuprofen, or some other blood thinners), as these might result in increased bruising or even bleeding on the injection site
  • Minimize strenuous exercise, exposure in order to extensive sun or heat, and alcoholic beverages within the first 24 hours following treatment, as these types of may cause short-term redness, inflammation, and/or itchiness at the shot web site
  • JUVÉDERM ®   VOLUMA ® XC was not analyzed in individuals with significant loose epidermis from the chin, neck, or jaw
  • The particular effect of JUVÉDERM ®   VOLUMA ® XC injection into the chin on facial hair growth has not been researched
  • Patients that experience skin injury near the site of JUVÉDERM ®   VOLUMA ®   XC injection may be at a higher risk for adverse events
  • Tell your doctor for those who have already been injected along with dermal fillers within the same area because the one(s) you are usually about to become treated to get. This information helps your doctor decide when and whether you should get therapy

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

These negative effects are in line with additional facial shot procedures, plus most will certainly resolve with time. Your physician may choose to treat unwanted effects persisting over 30 days along with antibiotics, steroid drugs, or hyaluronidase (an enzyme that breaks down hyaluronic acid).

As with all pores and skin injection procedures, there is a risk of contamination.

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

Products within the JUVÉDERM ®   Collection are obtainable only simply by a licensed physician or properly licensed practitioner.

References

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

SOURCE AbbVie

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