IRVINE, Calif., Feb. 8, 2022 /PRNewswire/ -- Allergan Aesthetics,
an AbbVie company (NYSE: ABBV), announces the FDA approval of
JUVÉDERM® VOLBELLA® XC for improvement of
infraorbital hollows in adults over the age of 21.2
According to clinical trial data, 90% of subjects reported
satisfaction through one year after treatment.2 With
this approval, Allergan Aesthetics continues the expansion of its
treatment portfolio to better address unmet patient needs. Per FDA
requirement for this new indication, Allergan Aesthetics is
providing a product training program for all interested providers,
which includes facial anatomy and considerations for safe injection
in this area, as well as identification and management of potential
complications. Successful completion of this training is
necessary prior to administration of JUVÉDERM®
VOLBELLA® XC for this new indication.
"This additional indication for JUVÉDERM®
VOLBELLA® XC demonstrates Allergan Aesthetics' continued
commitment to innovation. The eye area, including the undereye
hollow, is a top concern among patients," says Carrie Strom, President, Global Allergan
Aesthetics and Senior Vice President, AbbVie. "Allergan Aesthetics
offers the broadest portfolio of treatment options designed to
address the delicate eye area from topical skin care with
SkinMedica®, to crow's feet lines with BOTOX®
Cosmetic (onabotulinumtoxinA) and now, with this approval, the
infraorbital hollows, commonly referred to as tear troughs, with
JUVÉDERM® VOLBELLA® XC."
Patient safety and consumer satisfaction are a top priority at
Allergan Aesthetics. As the JUVÉDERM® Collection of
Fillers continues to be at the forefront of innovation, Allergan
Aesthetics is committed to providing best-in-class training to our
providers through the Allergan Medical Institute (AMI). During the
required infraorbital hollows training, providers will be educated
on how to assess facial anatomy holistically where
JUVÉDERM® VOLUMA® XC may be added as part of
a treatment plan to address volume loss in the midface. The safety
and efficacy of combined use of JUVÉDERM®
VOLUMA® XC and JUVÉDERM® VOLBELLA®
XC has not been studied. The required training can be accessed
and completed at VolbellaTraining.com.
"The undereye area is one of the most frequently requested
treatment sites among patients, regardless of race and ethnicity,
but it is undertreated.3 This is in part because it is a
sensitive area to inject as it takes great skill and precision,"
says AMI trainer, Board Certified Oculofacial Plastic Surgeon and
Ophthalmologist, Dr. Julie Woodward.
"The approval of JUVÉDERM® VOLBELLA® XC is a
milestone in offering providers, like myself, a safe and effective
treatment option to address the undereye area for my patients. The
characteristics of JUVÉDERM® VOLBELLA® XC
with lower amounts of hyaluronic acid molecules and low water
affinity provides a soft, smooth formulation appropriate for
treating undereye hollows and I am excited to work with Allergan
Aesthetics on a robust injector and patient education plan to
ensure safe and effective outcomes in this challenging to treat
area. The results of the clinical trial demonstrate
significant improvements in the appearance of undereye hollows and
overall appearance. In addition, 80% of subjects reported they were
a little or not at all bothered by how tired and old the under-eye
area looked at 3 months compared to 15% and 30% before treatment,
respectively.2"
According to the clinical studies, the primary effectiveness
criteria were met in the treatment group's responder rate of 83.1%
and was statistically significantly greater (p<0.0001) than the
responder rate for the no–treatment control group (15.6%) based on
the mITT population with multiple imputation. The mean improvement
was clinically significant (≥ 1 point), with the majority of
subjects demonstrating improvement through one year.5 In
addition, 90.1% of patients were willing to recommend the treatment
to a friend.5
Consumers and new patients who receive aesthetic treatment from
the JUVÉDERM® Collection of Fillers, can also enroll in
Allē, Allergan Aesthetics loyalty rewards program 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 program terms and conditions that apply. 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.
The majority of subjects in the clinical study experienced a
side effect, such as tenderness to touch, bruising, swelling,
lumps/bumps, redness, pain after injection, firmness, discoloration
(not redness or swelling), or itching as reported in their 30-day
daily diaries. A majority of these side effects were mild (easily
tolerated) in severity, although a few subjects experienced mild
swelling more than 30 days after treatment. The swelling was
treated with antibiotics for 1 subject; the other subjects did not
require treatment. All of these events resolved within 45
days.4
JUVÉDERM® VOLBELLA® XC was first
FDA–approved in 2016 for use in the lips and perioral
rhytids.2 As the category leader, the
JUVÉDERM® Collection of Fillers offers the broadest
portfolio of specifically tailored treatment options, and this
latest approval marks the sixth approved indication in the U.S.
For more information on the JUVÉDERM® Collection of
Fillers, visit Juvéderm.com and follow @JUVÉDERM on Instagram.
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® Collection of Fillers Important
Information
INDICATIONS
JUVÉDERM® VOLUMA® XC injectable gel 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.
JUVÉDERM® VOLLURE® XC injectable gel is
indicated for injection into the mid-to-deep dermis for correction
of moderate to severe facial wrinkles and folds (such as nasolabial
folds) in adults over the age of 21.
JUVÉDERM® VOLBELLA® XC injectable gel is
indicated for injection into the lips for lip augmentation and
correction of perioral rhytids, and for the improvement of
infraorbital hollowing in adults over the age of 21.
JUVÉDERM® Ultra Plus XC and JUVÉDERM®
Ultra XC injectable gels are indicated for injection into the
mid-to-deep dermis for correction of moderate to severe facial
wrinkles and folds (such as nasolabial folds).
JUVÉDERM® Ultra XC injectable gel is also indicated
for injection into the lips and perioral area for lip augmentation
in adults over the age of 21.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
These products 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 these products.
WARNINGS
- Do not inject into blood vessels. Introduction of these
products into the vasculature may lead to embolization, occlusion
of the vessels, ischemia, or infarction. Take extra care when
injecting soft-tissue fillers; for example, after insertion of the
needle and just before injection, the plunger rod can be withdrawn
slightly to aspirate and verify the needle is not intravascular,
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 risks of potential complications, this product
should only be used by healthcare professionals with appropriate
experience and training on facial anatomy and product use in
indicated area(s), vasculature, safe injection techniques, and
identification and management of potential adverse events,
including intravascular complications
- 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 indicated areas for each product have not been
established in controlled clinical studies
- The safety for use of these products during pregnancy, in
breastfeeding females, and in patients with known susceptibility to
keloid formation, hypertrophic scarring, and pigmentation disorders
has not been studied
- The safety for use of JUVÉDERM® VOLUMA®
XC has been established in patients between 35 and 65 years of age
for cheek augmentation and in patients between 22 and 80 years of
age for chin augmentation
- The safety for use of JUVÉDERM® Ultra Plus XC and
JUVÉDERM® Ultra XC in patients under 18 years, and
JUVÉDERM® VOLLURE® XC and
JUVÉDERM® VOLBELLA® XC in patients under 22
years, has not been established
- As with all transcutaneous procedures, dermal filler
implantation carries a risk of infection
- Dermal fillers should be used with caution in patients on
immunosuppressive therapy
- Patients taking medications 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
- If laser treatment, chemical peel, or any other procedure based
on active dermal response is considered after treatment, or before
skin has healed from a procedure prior to treatment, there is a
possible risk of eliciting an inflammatory reaction at the
injection site
- The safety for use of JUVÉDERM® VOLUMA®
XC injectable gel in patients with very thin skin in the mid-face
has not been established
- The safety of JUVÉDERM® VOLUMA® XC with
cannula for cheek augmentation has not been established in patients
with Fitzpatrick Skin Types V and VI
- JUVÉDERM® VOLUMA® XC was not evaluated in
subjects with significant skin laxity of the chin, neck, or jaw in
the chin augmentation study
- The effect of JUVÉDERM® VOLUMA® XC
injection into the chin on facial hair growth has not been
studied
- Patients may experience late-onset adverse events with use of
these dermal fillers, and late-onset nodules with use of
JUVÉDERM® VOLUMA® XC
- Based on preclinical studies, patients should be limited to 20
mL of any JUVÉDERM® injectable gel per 60 kg (130 lbs) body mass
per year. The safety of injecting greater amounts has not been
established
ADVERSE EVENTS
The most commonly reported side effects for JUVÉDERM®
injectable gels were redness, swelling, pain, tenderness, firmness,
lumps/bumps, bruising, discoloration, and itching. For
JUVÉDERM® VOLBELLA® XC, dryness was also
reported. The majority were mild or moderate in severity. For
JUVÉDERM® VOLUMA® XC, most resolved within 2
to 4 weeks. For JUVÉDERM® VOLLURE® XC,
JUVÉDERM® Ultra Plus XC, or JUVÉDERM® Ultra
XC, most resolved within 14 days; and for
JUVÉDERM® VOLBELLA® XC, most resolved within
30 days.
To report an adverse reaction with any product in the
JUVÉDERM® Collection, please call the
Allergan® Product Support Department at
1–877–345–5372. Please visit JuvedermDFU.com for more
information.
Products in the JUVÉDERM® Collection are available
only by a licensed physician or properly licensed practitioner.
BOTOX® COSMETIC IMPORTANT SAFETY INFORMATION AND
APPROVED USES
BOTOX® Cosmetic may cause serious side effects
that can be life threatening. Get medical help right away if you
have any of these problems any time (hours to weeks) after
injection of BOTOX® Cosmetic:
- Problems swallowing, speaking, or breathing, due to
weakening of associated muscles, can be severe and result in loss
of life. You are at the highest risk if these problems are
pre-existing before injection. Swallowing problems may last for
several months.
- Spread of toxin effects. The effect of botulinum toxin
may affect areas away from the injection site and cause serious
symptoms including: loss of strength and all-over muscle weakness,
double vision, blurred vision and drooping eyelids, hoarseness or
change or loss of voice, trouble saying words clearly, loss of
bladder control, trouble breathing, and trouble swallowing.
BOTOX® Cosmetic dosing units are not the same as,
or comparable to, any other botulinum toxin product.
There has not been a confirmed serious case of spread of toxin
effect when BOTOX® Cosmetic has been used at the
recommended dose to treat frown lines, crow's feet lines, and/or
forehead lines.
BOTOX® Cosmetic may cause loss of strength or general
muscle weakness, vision problems, or dizziness within hours to
weeks of taking BOTOX® Cosmetic. If this happens, do
not drive a car, operate machinery, or do other dangerous
activities.
Serious and/or immediate allergic reactions have been
reported. They include: itching, rash, red itchy welts,
wheezing, asthma symptoms, or dizziness or feeling faint. Get
medical help right away if you are wheezing or have asthma
symptoms, or if you become dizzy or faint.
Do not receive BOTOX® Cosmetic if you: are
allergic to any of the ingredients in BOTOX® Cosmetic
(see Medication Guide for ingredients); had an allergic reaction to
any other botulinum toxin product such as
Myobloc® (rimabotulinumtoxinB),
Dysport® (abobotulinumtoxinA), or
Xeomin® (incobotulinumtoxinA); have a skin
infection at the planned injection site.
Tell your doctor about all your muscle or nerve
conditions, such as ALS or Lou
Gehrig's disease, myasthenia gravis, or Lambert-Eaton
syndrome, as you may be at increased risk of serious side effects
including difficulty swallowing and difficulty breathing from
typical doses of BOTOX® Cosmetic.
Tell your doctor about all your medical conditions,
including: plans to have surgery; had surgery on your face; have
trouble raising your eyebrows; drooping eyelids; any other abnormal
facial change; are pregnant or plan to become pregnant (it is not
known if BOTOX® Cosmetic can harm your unborn baby); are
breast-feeding or plan to (it is not known if BOTOX®
Cosmetic passes into breast milk).
Tell your doctor about all the medicines you take,
including prescription and over-the-counter medicines, vitamins,
and herbal supplements. Using BOTOX® Cosmetic with
certain other medicines may cause serious side effects. Do not
start any new medicines until you have told your doctor that you
have received BOTOX® Cosmetic in the past.
Tell your doctor if you have received any other botulinum toxin
product in the last 4 months; have received injections of botulinum
toxin such as Myobloc®,
Dysport®, or Xeomin® in the
past (tell your doctor exactly which product you received); have
recently received an antibiotic by injection; take muscle
relaxants; take an allergy or cold medicine; take a sleep medicine;
take aspirin-like products or blood thinners.
Other side effects of BOTOX® Cosmetic include:
dry mouth; discomfort or pain at the injection site; tiredness;
headache; neck pain; and eye problems: double vision, blurred
vision, decreased eyesight, drooping eyelids and eyebrows, swelling
of your eyelids and dry eyes.
APPROVED USES
BOTOX® Cosmetic is a prescription medicine that
is injected into muscles and used to temporarily improve the look
of moderate to severe forehead lines, crow's feet lines, and frown
lines between the eyebrows in adults.
For more information refer to the Medication Guide or talk with
your doctor.
To report a side effect, please call Allergan at
1-800-678-1605.
Please see BOTOX® Cosmetic
full Product Information including Boxed
Warning and Medication Guide.
References
- Allergan Data On File Monthly Tracking Report, 2020
- Allergan Data On File JUVÉDERM®
VOLBELLA® XC Patient Label 2021
- Allergan Data On File Filler Situational Analysis 2020
- Allergan Data On File JUVÉDERM®
VOLBELLA® XC Directions for Use 2021
- DOF Volbella Infraorbital Hollowing CSR Body Text 2019
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SOURCE AbbVie