IRVINE, Calif., June 15, 2020 /PRNewswire/ -- Today
Allergan Aesthetics, an AbbVie company (NYSE: ABBV), announced the
FDA approval of JUVÉDERM®
VOLUMA™ XC for the augmentation of the chin
region to improve the chin profile in adults over the age of
21.1 As the category leader, the JUVÉDERM®
Collection of Fillers has the broadest portfolio of specifically
tailored treatment options, and this latest approval marks their
fifth approved indication in the U.S.1-5
"When assessing facial anatomy, the chin is a critical component
to facial balance, yet it is often overlooked. Due to its distinct
gel properties and product profile, JUVÉDERM®
VOLUMA™ XC is uniquely suitable to address
this need," says Carrie Strom,
Senior Vice President, AbbVie, and President, Global Allergan
Aesthetics. "It's always rewarding when we can offer a safe and
effective non-surgical alternative to patients. Addressing chin
contour and shape is another way we are moving the market forward
through our commitment to continued innovation."
JUVÉDERM® VOLUMA™ XC is the
first and only filler to receive U.S. FDA approval for the
augmentation of the chin region.1 This approval marks
the second indication for the product, which was previously
approved by the FDA in 2013 for cheek augmentation to correct
age-related mid-face volume deficit. 2
JUVÉDERM® VOLUMA™ XC is
currently the number one product in the JUVÉDERM®
portfolio in the U.S. and lasts up to two years with optimal
treatment for cheek augmentation. 1,7
"Within my practice, I've seen a growing demand for patients
looking to achieve more balanced symmetry in the face. During
facial assessments, most patients don't realize that chin
augmentation is another component to achieving the facial harmony
they desire," says Dee Anna Glaser,
MD, dermatologist in St. Louis and
clinical trial investigator. "This approval is a truly exciting
milestone for providers as it signals another paradigm shift in the
way we are able to approach a facial consultation. I am excited to
educate patients that we have a safe and predictable non-surgical
treatment option to address their concern."
In the U.S. pivotal study, JUVÉDERM®
VOLUMA™ XC was shown to be safe and effective for
augmentation of the chin, with the majority of patients reporting
high satisfaction throughout the 1-year
follow-up.1
Since 2018, all clinical trials for the Allergan Aesthetics
portfolio have included participants reflective of a diverse
patient population and demographics, including varying genders,
ages, races, and ethnicities.
To learn more about JUVÉDERM®
VOLUMA™ XC and the full collection of
fillers, please visit www.juvederm.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® VOLUMA™ XC
Important Information
INDICATIONS
JUVÉDERM® VOLUMA™
XC is indicated for deep (subcutaneous and/or supraperiosteal)
injection for cheek augmentation to correct age-related volume
deficit in the mid-face and for augmentation of the chin region to
improve the chin profile in adults over the age of 21.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
This product should not be used in
patients who have severe allergies, marked by a history of
anaphylaxis or history or presence of multiple severe allergies,
and should not be used in patients with a history of allergies to
Gram-positive bacterial proteins or lidocaine contained in this
product.
WARNINGS
- Do not inject into blood vessels. Introduction of this product
into the vasculature may lead to embolization, occlusion of the
vessels, ischemia or infarction. Take extra care when injecting
soft-tissue fillers; for example, inject the product slowly and
apply the least amount of pressure necessary. Rare, but serious,
adverse events associated with the intravascular injection of
soft-tissue fillers in the face have been reported and include
temporary or permanent vision impairment, blindness, cerebral
ischemia or cerebral hemorrhage leading to stroke, skin necrosis,
and damage to underlying facial structures. Immediately stop the
injection if a patient exhibits any of the following symptoms:
changes in vision, signs of a stroke, blanching of the skin,
unusual pain during or shortly after the procedure. Patients should
receive prompt medical attention and, possibly, evaluation by an
appropriate healthcare professional specialist should an
intravascular injection occur
- Product use at specific sites in which an active inflammatory
process (skin eruptions such as cysts, pimples, rashes, or hives)
or infection is present should be deferred until the underlying
process has been controlled
PRECAUTIONS
- To minimize the risk of potential complications, this product
should only be used by healthcare professionals who have
appropriate training, experience, and knowledge of facial anatomy,
and the product for use in deep injection for cheek and chin
augmentation
- The potential risks of soft-tissue injections should be
discussed with patients prior to treatment to ensure they are aware
of signs and symptoms of complications
- The safety and effectiveness for the treatment of anatomic
regions other than the mid-face, chin, and pre-jowl sulcus regions
have not been established in controlled clinical studies
- The safety for use during pregnancy, in breastfeeding females,
and in patients with very thin skin in the mid-face region has not
been established
- The safety has been established for use in patients between 35
and 65 years of age for cheek augmentation and patients between 22
and 80 years of age for chin augmentation
- The safety in patients with known susceptibility to keloid
formation, hypertrophic scarring, and pigmentation disorders has
not been studied
- As with all transcutaneous procedures, dermal filler
implantation carries a risk of
infection
- Use with caution in patients on immunosuppressive therapy
- Patients who are using products that can prolong bleeding (such
as aspirin, nonsteroidal anti-inflammatory drugs, and warfarin) may
experience increased bruising or bleeding at treatment sites
- Patients who experience skin injury near the site of
implantation may be at a higher risk for adverse events
- Patients may experience late onset nodules with use of dermal
fillers including JUVÉDERM® VOLUMA™ XC
- The safety of JUVÉDERM® VOLUMA™ XC with
cannula for cheek augmentation has not been established in patients
with Fitzpatrick Skin Types V and VI.
- In the chin study, the device was not evaluated in subjects
with significant skin laxity of the chin, neck or jaw
- The effect of JUVÉDERM® VOLUMA™ XC
injection into the chin on facial hair growth has not been
studied
ADVERSE EVENTS
Adverse events in > 5% of subjects
were tenderness, firmness, swelling, lumps/bumps, pain, bruising,
redness, discoloration, and itching. These events were
predominately mild or moderate in severity across all studies and
most resolved within 2-4 weeks.
For more information, please visit JuvedermDFU.com . To
report an adverse reaction, please call Allergan at
1-800-433-8871.
JUVÉDERM® VOLUMA™ XC is available only
by a licensed physician or properly licensed practitioner.
References
- JUVÉDERM® VOLUMA™ XC Directions for
Use, 2020.
- JUVÉDERM® VOLUMA™ XC Patient
Labeling, 2019.
- JUVÉDERM® ULTRA XC Patient Labeling, 2019.
- JUVÉDERM® VOLBELLA™ XC Patient
Labeling, 2019.
- JUVÉDERM® XC Patient Labeling, 2019.
- JUVÉDERM® VOLLURE™ XC Patient Labeling,
2019.
- Allergan Data On File Proforma Sales, 2015.
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SOURCE AbbVie