–Data results shared across facial injectables, body
contouring and skincare portfolio highlights Allergan Aesthetics'
continued commitment to advancing aesthetic
medicine
–Analyses of 15 years of post-marketing
surveillance data demonstrate the global reported rate of
delayed-onset nodules associated with dermal fillers on the Vycross
technology platform is low (<0.016%).
–Results from 3
clinical studies showcasing a customizable platform with
patent-pending LTN Complex, to address the appearance of facial
hyperpigmentation in a wide range of demographic
populations
–Dr. DiAnne
Davis to discuss the new Forces of Beauty® Report
from the DREAM (Driving Racial Equity in Aesthetic Medicine)
Initiative® and at Diversity, Equity and Inclusion (DEI)
reception
IRVINE,
Calif., Oct. 7, 2022 /PRNewswire/ -- Allergan
Aesthetics, an AbbVie company, (NYSE: ABBV) announced today that
eight scientific abstracts from its leading portfolio of aesthetic
products and treatments will be presented at the American Society
for Dermatologic Surgery (ASDS) meeting taking place October 6-10 in Denver.
Allergan Aesthetics has one of the largest, most-researched
portfolio and pipeline in the medical aesthetics industry. Data
presented across a broad spectrum of aesthetic indications aims to
further scientific research and improve patient outcomes.
"Our scientific excellence continues to help drive advancements
in aesthetic medicine, as well bring impactful treatments to our
customers and patients globally," said Darin Messina, Senior Vice President, Allergan
Aesthetics R&D. "The data presented at ASDS reinforces our
leadership in aesthetics and also the commitment of our research
and development team to drive innovation for the industry and share
learnings with the broader medical community."
At the meeting, researchers will spotlight global post-marketing
surveillance data on the reported rates of delayed-onset nodules
presenting four or more weeks after injection of hyaluronic acid
fillers based on the Vycross technology platform. The analyses of
15 years of data demonstrate the global reported rate of
delayed-onset nodules associated with dermal fillers on the Vycross
technology platform is low (<0.016%). Inflammatory nodules,
which typically require intervention/treatment, were reported less
frequently than non-inflammatory nodules.
Additionally, Dr. DiAnne Davis, a
board-certified cosmetic dermatologist out of Dallas, Texas, will discuss the new Forces of
Beauty® Report from Allergan Aesthetics' DREAM (Driving
Racial Equity in Aesthetic Medicine) Initiative® at the
Diversity, Equity and Inclusion (DEI) reception on Friday, October 7. The report provides a new
understanding of what inclusive and representative beauty looks
like today by shedding light on how narrowly defined Eurocentric
ideals continue to impact women of color. By surveying over 4,000
women aged 21-65, from multiple geographic locations and
backgrounds, the report explores what defines beauty, how beauty
impacts women's lives, and the interplay between beauty and
race.
Key abstracts are outlined below. Complete abstracts and details
on presentation dates and times can be found on the ASDS
website.
Abstract
Title
|
Presentation
Details
|
Facial
|
Hyaluronic Acid Filler
VYC-25L for Jawline Restoration Yields
High Satisfaction, Improved Jawline Measurements, and
Sustained Effect Across Age, Gender, and Skin Types for up
to 12 Months
|
Virtual
Presentation
|
Delayed-onset Nodules
Following Vycross Hyaluronic Acid
Filler Injections: Reported Rates From Global Post-marketing
Surveillance
|
Virtual
Presentation
|
Body
Contouring
|
A Prospective,
Open-Label Study to Evaluate Functional
Changes Following Electromagnetic Muscle Stimulation of
Abdominal Muscle
|
Virtual
Presentation
|
Multi-Country Study to
Evaluate Patient Satisfaction with a
Dual Applicator Cryolipolysis System for Non-Invasive Fat
Reduction in Abdomen, Flanks, Upper Arms, Inner Thighs,
Outer Thighs, and Submental Area (Study Design)
|
Virtual
Presentation
|
Mechanism for
Improvement in the Appearance of Skin Laxity
Resulting from a Single Treatment With Acoustic Subcision:
Induction of New Collagen (Type III) and Elastin
|
Virtual
Presentation
|
Skincare
|
Efficacy and
Tolerability of Novel Topical Pigment-Correcting
Serums With Biweekly Diamond Tip Microdermabrasion
Treatments on Facial Hyperpigmentation (HP), Including
Melasma and Post-inflammatory HP
|
Virtual
Presentation
|
Efficacy of Novel
Multimodality Pigment-Correcting Serum for
Moderate to Severe Facial Hyperpigmentation, Including
Melasma, in a 12-Week, Split-Face, Double-blind,
Randomized Controlled Trial
|
Virtual
Presentation
|
Efficacy of a Targeted
Pigment-Correcting Spot Treatment
Cream for Solar Lentigines and Post-inflammatory
Hyperpigmentation in a 12-Week, Single-Center Clinical
Study
|
Virtual
Presentation
|
IMPORTANT SAFETY INFORMATION & APPROVED USES
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® VOLUX™ XC injectable gel is indicated
for subcutaneous and/or supraperiosteal injection for improvement
of jawline definition in adults over the age of 21 with moderate to
severe loss of jawline definition.
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 risk of potential complications, these products
should only be used by healthcare professionals who are
knowledgeable about the anatomy and the product(s) for use in
indicated area(s), and who have appropriate training in facial
anatomy, vasculature, safe injection techniques, and identification
and management of potential adverse events, including intravascular
complications
- The potential risks of soft issue 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 in patients with known
susceptibility to keloid formation, hypertrophic scarring, and
pigmentation disorders has not been studied
- The safety for use during pregnancy and in breastfeeding
females has not been established
- 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 the safety for use of JUVÉDERM® VOLUX™ XC,
JUVÉDERM® VOLLURE® XC, and
JUVÉDERM® VOLBELLA® XC in patients
under 22 years, has not been established
- Dermal filler implantation carries a risk of infection. Follow
standard precautions
- 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 for use 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
injectable gel implants, 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 (132
lb) body mass per year. The safety of injecting greater amounts has
not been established
- Injection of more than 9 mL of JUVÉDERM® VOLUX™
XC for improvement of jawline definition has not been studied
ADVERSE EVENTS
The most common 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.
To report an adverse reaction with any product in the
JUVÉDERM® Collection, please call
Allergan® Product Support 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.
Please see Directions for Use or visit
https://www.rxabbvie.com/pdf/juvederm-voluma-xc_dfu.pdf for
JUVÉDERM® VOLUMA® XC
Please see Directions for Use or visit
https://www.rxabbvie.com/pdf/juvederm-volux-xc_dfu.pdf for
JUVÉDERM® VOLUX™ XC
Please see Directions for Use or visit
https://www.rxabbvie.com/pdf/juvederm-vollure-xc_dfu.pdf for
JUVÉDERM® VOLLURE® XC
Please see Directions for Use or visit
https://www.rxabbvie.com/pdf/juvederm-volbella_dfu.pdf for
JUVÉDERM® VOLBELLA® XC
Please see Directions for Use or visit
https://www.rxabbvie.com/pdf/juvederm-ultra-plus-xc_dfu.pdf for
JUVÉDERM® Ultra Plus XC
Please see Directions for Use or visit
https://www.rxabbvie.com/pdf/juvederm-ultra-xc_dfu.pdf for
JUVÉDERM® Ultra XC
Indications
CoolSculpting® Elite is
FDA-cleared for the treatment of visible fat bulges in the thigh,
abdomen, and flank, along with bra fat, back fat, underneath the
buttocks (also known as banana roll), and upper arm in patients
with a Body Mass Index (BMI) of ≤ 30, and in submental and
submandibular areas in patients with a BMI of ≤ 46.2. It is also
FDA-cleared to affect the appearance of lax tissue with submental
area treatments.
Important Safety
Information
CoolSculpting® Elite is
contraindicated in patients with cryoglobulinemia, cold agglutinin
disease, or paroxysmal cold hemoglobinuria.
Ask your patient about any medical conditions including recent
surgery, pre-existing hernia, and any known sensitivities or
allergies.
During the procedure patients may experience sensations of
pulling, tugging, mild pinching, intense cold, tingling, stinging,
aching, and cramping at the treatment site. These sensations
subside as the area becomes numb. Following the procedure, typical
side effects include temporary redness, swelling, blanching,
bruising, firmness, tingling, stinging, tenderness, cramping,
aching, itching, or skin sensitivity, and sensation of fullness in
the back of the throat after submental or submandibular area
treatment.
Rare side effects may also occur. Paradoxical hyperplasia
(visibly enlarged tissue volume in the treated area) may develop 2
to 5 months after treatment, will not resolve on its
own, and may require surgical intervention for correction.
As with any medical procedure, a consultation should be done by
a licensed healthcare professional to determine if the patient is a
candidate for treatment. For a complete list of Contraindications,
Warnings, Precautions, and Potential Side Effects, consult the
CoolSculpting® Elite System User Manual.
Treatment applications that deviate from the guidelines are not
recommended.
CoolTone® Uses
The CoolTone®
device is FDA-cleared for improvement of abdominal tone,
strengthening of the abdominal muscles, and development for firmer
abdomen. CoolTone® is also FDA-cleared for
strengthening, toning, and firming of buttocks and thighs.
CoolTone® Important Safety Information
The
CoolTone® procedure is not for everyone. You should not
have the CoolTone® treatment in areas with metal,
electrical, or electronic implants/devices like cardiac pacemakers,
implanted hearing devices, implanted defibrillators, implanted
neurostimulators, drug pumps, or hearing aids.
Tell your doctor if you have any medical conditions as
CoolTone® should not be used over a menstruating uterus,
over areas of the skin that lack normal sensation, in patients with
fever, malignant tumor, hemorrhagic conditions, epilepsy, recent
surgical procedure, pulmonary insufficiency, or pregnancy.
CoolTone® should be used with caution in patients
with Graves' disease (an autoimmune disorder that causes overactive
thyroid), active bleeding disorders, or seizure disorders.
Women who are close to menstruation may find that it comes
sooner, or cramping is increased or intensified with
CoolTone® treatments, therefore, it is recommended to
not undergo treatment during this time of the month.
CoolTone® should not be used in the heart or head
areas, areas of new bone growth, over the carotid sinus nerves, or
over the neck or mouth. CoolTone® should not be applied
over swollen, infected, inflamed areas or skin eruptions. Caution
should be used for patients with suspected or diagnosed heart
problems.
Common side effects may include, but may not be limited to,
muscular pain, temporary muscle spasm, temporary joint or tendon
pain, and redness at or near the treatment site.
Ask your Healthcare Provider if CoolTone® is right
for you.
Please see full Important Safety Information for additional
information at coolsculpting.com/cooltone.
Patient results may vary.
RESONIC™ Important Safety Information
RESONIC™ (Rapid
Acoustic Pulse™ device) is indicated for use as an accessory to the
1064 nm Q-Switched laser for black ink tattoo removal in
Fitzpatrick Skin Type I-III patients. The RESONIC device is also
indicated for long-term improvement in the appearance of cellulite
as supported by clinical data demonstrating treatment benefits up
to 1 year of observation. The most common side effects may include
mild to moderate temporary redness of the treatment site, mild
pain, heat, and pinpoint redness. Your results and experience may
vary, so it is important to talk to your healthcare provider about
whether RESONIC is right for you. For full safety information,
please visit www.RESONIC.com/ISI.
DiamondGlow® Uses
The
DiamondGlow® device is a general dermabrasion
device that gently removes the top layer of skin and delivers
topical cosmetic serums onto the skin.
DiamondGlow® Important Safety
Information
The DiamondGlow® treatment is not for
everyone. You should not have a DiamondGlow® treatment
if you have compromised skin quality. Tell your provider if you are
pregnant or lactating, or if you have medical condition, including
allergies, and if you are using topical medications on the area to
be treated.
Typical side effects include a scratchy, stinging sensation
during the treatment and temporary tightness, redness or slight
swelling after the treatment. Rare serious side effects may also
occur and include severe skin irritation and allergic
reactions.
SkinMedica® Pro-Infusion Serums
Disclaimer
SkinMedica® Pro-Infusion Serums are
intended to meet the FDA's definition of a cosmetic product, an
article applies to the human body to cleanse, beautify, promote
attractiveness, and alter appearances. These products are not
intended to be drugs that diagnose, treat, cure, or prevent any
disease or condition. These products have not been approved by the
FDA and the statements have not been evaluated by the FDA.
About Allergan Aesthetics
Allergan Aesthetics, an AbbVie company, develops, manufactures, and
markets a portfolio of leading aesthetics brands and products.
Their aesthetics portfolio includes facial injectables, body
contouring, plastics, skin care, and more. Their goal is to
consistently provide customers worldwide with innovation,
education, exceptional service, and a commitment to excellence, all
with a personal touch. www.AllerganAesthetics.com
Forward-Looking Statements
Some statements in this news release are, or may be considered,
forward-looking statements for purposes of the Private Securities
Litigation Reform Act of 1995. The words "believe," "expect,"
"anticipate," "project" and similar expressions, among others,
generally identify forward-looking statements. AbbVie cautions that
these forward-looking statements are subject to risks and
uncertainties that may cause actual results to differ materially
from those indicated in the forward-looking statements. Such risks
and uncertainties include, but are not limited to, failure to
realize the expected benefits from AbbVie's acquisition of Allergan
plc ("Allergan"), failure to promptly and effectively integrate
Allergan's businesses, competition from other products, challenges
to intellectual property, difficulties inherent in the research and
development process, adverse litigation or government action,
changes to laws and regulations applicable to our industry and the
impact of public health outbreaks, epidemics or pandemics, such as
COVID-19. Additional information about the economic, competitive,
governmental, technological and other factors that may affect
AbbVie's operations is set forth in Item 1A, "Risk Factors," of
AbbVie's 2021 Annual Report on Form 10-K, which has been filed with
the Securities and Exchange Commission, as updated by its
subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no
obligation to release publicly any revisions to forward-looking
statements as a result of subsequent events or developments, except
as required by law.
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