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 Twitter, Facebook, Instagram, YouTube 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
- Allergan Data On File JUVÉDERM® VOLUX™ XC Patient
Label 2022
- Allergan Data On File JUVÉDERM® VOLUMA®
XC Patient Label 2020
- Allergan Data On File JUVÉDERM® VOLBELLA®
XC Patient Label 2020
- Allergan Data On File JUVÉDERM® VOLUX™ XC Directions
For Use 2022
- Allergan Data On File JUVÉDERM® VOLLURE®
XC Patient Label 2020
- Allergan Data On File JUVÉDERM® Ultra Plus XC
Patient Label 2020
- Allergan Data On File JUVÉDERM® Ultra XC Patient
Label 2020
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SOURCE AbbVie