THE FIRST AND ONLY HYALURONIC ACID DERMAL
FILLER APPROVED FOR THE IMPROVEMENT OF MODERATE TO SEVERE TEMPLE
HOLLOWING1
IRVINE, Calif., March 5, 2024 /PRNewswire/ --
Today, Allergan Aesthetics, an AbbVie company (NYSE: ABBV),
announced the U.S. FDA approval of JUVÉDERM®
VOLUMA® XC for injection in the temple region to improve
moderate to severe temple hollowing in adults over the age of
21.1 JUVÉDERM® VOLUMA® XC is the
first and only hyaluronic acid (HA) dermal filler to receive U.S.
FDA approval for the improvement of moderate to severe temple
hollowing with results lasting up to 13 months with optimal
treatment.*1
"The approval of JUVÉDERM® VOLUMA® XC to
treat temple hollows further demonstrates Allergan Aesthetics
commitment to innovation and addressing patient needs," said
Carrie Strom, President, Allergan
Aesthetics and Senior Vice President, AbbVie. "This is the first
U.S. FDA approval of a hyaluronic acid dermal filler for use in the
upper face and addresses a real unmet need for patients."
JUVÉDERM® VOLUMA® XC temporarily adds
volume to immediately lift and augment the shape, contour, and
structure of the temple, creating a smooth transition from the
cheekbone to the forehead, balancing a patient's overall facial
shape.1 In a clinical study, more than 80% of subjects
had at least a one-point improvement in moderate to severe temple
hollowing three months after treatment, and the improvement lasted
for more than one year (73%).1 Additionally, more than
85% of clinical trial subjects were satisfied with how balanced,
well-proportioned, and symmetric their face looked three months
after treatment.1
In the clinical study, 68% of subjects reported satisfaction
with how fresh their face looked, while 73% reported satisfaction
with how rested their face appeared three months after
treatment.1 Additionally, upwards of 80% of subjects
were satisfied with how youthful their temples made them look and
how well the shape of their temples complemented the shape of their
face three months after treatment.1 With this addition,
the Allergan Medical Institute (AMI) team can
train aesthetic providers on safe and effective treatments using
the Allergan Aesthetics portfolio to address 90% of the face.
"As an AMI trainer, I am excited to start training
injectors on how to use JUVÉDERM® VOLUMA® XC
to help address moderate to severe temple hollowing while
reinforcing how treatment in this important area fits into a
full-face approach that enhances facial balance (framing) and
contour for my patients seeking subtle improvement," said Dr.
Deirdre Hooper, board-certified
dermatologist at Audubon Dermatology, and clinical trial
investigator. "In the clinical study, we found that patients said
they looked an average of five years younger six months after
JUVÉDERM® VOLUMA® XC treatment.1
Additionally, more than 85% of clinical study participants were
satisfied with the treatment and would recommend it to a friend
more than one year after treatment.1 Once training is
completed, injectors like me will be able to offer patients true
pan-facial assessments and treatments for safe, repeatable, and
optimal results using the Allergan Aesthetics portfolio of
products."
Per FDA requirement for this new indication, Allergan Aesthetics
is providing a product training program for providers, which
includes facial anatomy and considerations for patient selection,
safe injection in this area, as well as identification and
management of potential complications. Successful completion of
this training is necessary prior to the administration of
JUVÉDERM® VOLUMA® XC, and as such, Allergan
Aesthetics anticipates that treatment in the temples with
JUVÉDERM® VOLUMA® XC will be available
towards the end of this year.
In a randomized, controlled, multicenter clinical study to
evaluate the safety and effectiveness of
JUVÉDERM® VOLUMA® XC for correction
of temple hollowing, 112 subjects were randomized to a treatment
group and received injections in the temple area during the primary
phase of the study; 58 subjects were randomized to a no-treatment
control group.1 Touch-up treatments occurred
approximately 30 days after initial injection, if
needed.1 After the three-month blinded "no treatment"
control period, control subjects were offered treatment; 53 control
subjects elected to receive treatment.2 A total of 40
treatment-group subjects opted for the optional maintenance
treatment, which was offered to the treatment group 13 months after
the last treatment.2
Subjects used electronic diaries to record specific signs and
symptoms of treatment site responses (TSR) experienced during the
first 14 days after the initial touch-up and maintenance
treatments.2 Subjects in the initial treatment group
continued to use the electronic diary on even-numbered days from
day 16 to day 30 to record specific signs and symptoms of
TSRs.2 Subjects rated each TSR listed on the diary as
"Mild (barely noticeable)," "Moderate (uncomfortable)," "Severe
(severe discomfort)," or "None."2
After initial treatment with JUVÉDERM®
VOLUMA® XC, 59% of the subjects with diary entries
reported experiencing at least one TSR and 70.5% of subjects
rated TSRs as mild or moderate (26.3%) in severity, with a majority
(60%) of all reported TSRs resolving within three days.2
The incidence of TSRs for the touch-up and maintenance treatments
was lower than that for initial treatment.2
JUVÉDERM® VOLUMA® XC, one of six
specifically designed products in the JUVÉDERM®
Collection of Fillers, is currently also indicated for deep
(subcutaneous and/or supraperiosteal) injection for cheek
augmentation to correct age-related volume loss in the mid-face,
and for augmentation of the chin region to improve the chin
profile.3,4
To learn more about the JUVÉDERM® Collection of
Fillers, visit www.juvederm.com and follow @JUVEDERM on social
media. For aesthetic providers interested in learning more about
injection training, please speak to your Allergan Aesthetics
Business Development Manager.
*Some patients may require a touch-up treatment to achieve
desired result.
JUVÉDERM® VOLUMA® XC
Injectable Gel Important Information
APPROVED USES
JUVÉDERM® VOLUMA® XC injectable gel is for
deep injection in the cheek area to correct age-related volume
loss, for augmentation of the chin region to improve the chin
profile, and for augmentation of the temple region to improve
moderate to severe temple hollowing in adults over 21.
IMPORTANT SAFETY INFORMATION
Are there any reasons why I should not receive any
JUVÉDERM® formulation?
Do not use 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.
- If you have changes in your vision, signs of a stroke
(including sudden difficulty speaking, numbness or weakness in your
face, arms or legs, difficulty walking, face drooping, severe
headache, dizziness, or confusion), white appearance of the skin,
or unusual pain during or shortly after treatment, you should
notify your health care practitioner immediately.
- The use of dermal fillers where skin sores, pimples, rashes,
hives, cysts, or infections are present should be postponed until
healing is complete, as these could delay healing or make your skin
problems worse.
- The effectiveness of removal of any dermal filler has not been
studied.
What precautions should my doctor advise me about?
- Avoid applying makeup for 12 hours after treatment and minimize
strenuous exercise and exposure to extensive sun or heat within the
first 24 hours following treatment. Exposure to any of these may
cause temporary redness, swelling, and/or itching at the injection
site
- Tell your doctor if you are pregnant or breastfeeding. 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, under 22 years or over 80 years for chin
augmentation, and under 32 years or over 82 years for temple area
augmentation
- The safety and effectiveness of treatment with
JUVÉDERM® products in anatomical regions outside of
their approved uses have not been established in clinical
studies
- Tell your doctor if you have a history of excessive scarring
(thick, hard scars) or pigmentation disorders. The safety of
JUVÉDERM® VOLUMA® XC in patients with a
history of excessive scarring or pigmentation disorders has not
been studied. Use in these patients may result in additional scars
or changes in pigmentation
- 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
- 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
- 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 have already been injected with dermal
fillers in the same area as the one(s) you are about to be treated
for
What are possible side effects?
The most common
reported side effects were tenderness, firmness, swelling,
lumps/bumps, pain, bruising, redness, discoloration, and itching.
The majority were mild or moderate in severity across all studies
and resolved within 2 to 4 weeks.
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.
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 and solutions 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,
and eye care – and products and services in our Allergan Aesthetics
portfolio. For more information about AbbVie, please visit us at
www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X
(formerly Twitter), and YouTube.
References
- JUVÉDERM® VOLUMA® XC Patient Labeling for
Temple. 2024.
- JUVÉDERM® VOLUMA® XC Directions for Use.
2024.
- JUVÉDERM® VOLUMA® XC Patient Labeling for
Cheek. 2019.
- JUVÉDERM® VOLUMA® XC Patient Labeling for
Chin. 2020.
View original content to download
multimedia:https://www.prnewswire.com/news-releases/juvederm-voluma-xc-for-temple-hollows-receives-us-fda-approval-302079738.html
SOURCE AbbVie