THE FIRST AND ONLY HYALURONIC ACID
INTRADERMAL MICRODROPLET INJECTION, APPROVED FOR IMPROVED SKIN
SMOOTHNESS OF THE CHEEKS
IRVINE,
Calif., May 15, 2023 /PRNewswire/ -- Today,
Allergan Aesthetics, an AbbVie company (NYSE: ABBV), announced
the U.S. FDA approval of SKINVIVE™ by JUVÉDERM® to
improve skin smoothness of the cheeks in adults over the age of
21.1 SKINVIVE™ by JUVÉDERM® is the first and
only hyaluronic acid (HA) intradermal microdroplet injection for
skin smoothness available in the U.S. with results lasting through
six months with optimal treatment.1
![SKINVIVE™ by JUVÉDERM® is FDA approved for improved skin smoothness of the cheeks in adults over the age of 21. SKINVIVE™ by JUVÉDERM® is FDA approved for improved skin smoothness of the cheeks in adults over the age of 21.](https://mma.prnewswire.com/media/2076569/SKINVIVE__by_JUVEDERM__Packaging.jpg)
SKINVIVE™ by JUVÉDERM® is a smooth, injectable HA gel
that contains a small amount of local anesthetic
(lidocaine).1 Unlike other facial injectables that
enhance and augment the treatment area, SKINVIVE™ by
JUVÉDERM® improves skin quality in the cheeks by
smoothing the skin and increasing hydration. SKINVIVE™ by
JUVÉDERM® is a specialized, smooth, hydrating gel
that flows easily into the skin and is approved for all Fitzpatrick
Skin Types I-VI, lightest to darkest, addressing an important unmet
need in the skin quality category.3 The product was
designed with global skin health experts to improve smoothness of
the cheeks leading to a lasting glow.* Treatment is
minimally invasive, offers little to no downtime, and provides
results over the course of six months without requiring a recurring
series of treatments.1†
"SKINVIVE™ by JUVÉDERM® is a category-creating
HA product that leaves skin looking healthier, more glowing, and
more hydrated," said Carrie Strom,
President, Global Allergan Aesthetics and Senior Vice President,
AbbVie. "This unique product is a result of our vast experience in
HA science and complements our current collection of HA products,
with the JUVÉDERM® Collection of Fillers and
SkinMedica® topicals."
"Skin quality is among the top concerns my patients express when
seeking aesthetic treatments. It's an extremely important factor I
consider in my therapeutic process of restoring their natural
beauty and appearance," said Macrene Alexiades, M.D., Ph.D., dual
U.S.-EU board-certified dermatologist, SKINVIVE™ by
JUVÉDERM® lead investigator, and author of the clinical
trial published in Dermatologic Surgery. "One key way to improve
skin quality is by enhancing hydration. SKINVIVE™ by
JUVÉDERM® is truly innovative because it works
beneath the skin's surface to increase skin hydration improving
skin quality. I am excited to add this unique offering to my
dermatologic treatment regimen for my patients."
*Glow was reported by patients using a validated scale that
included satisfaction with how radiant their skin looked.
†Optimal treatment with SKINVIVE™ by JUVÉDERM® may
require an optional touch-up one month after initial treatment to
achieve the desired aesthetic outcome and is dependent on patient
need.1
In a European post-marketing study, changes in aquaporin were
observed after SKINVIVE™ by JUVÉDERM® treatment.
Aquaporin is a hydration marker that facilitates the flow of water
and glycerol into and out of cells. Increases in aquaporin may
signal an increase of skin hydration. Allergan Aesthetics is
looking to pursue further research to better understand the
significance of the changes in aquaporin observed after SKINVIVE™
by JUVÉDERM® treatment, as demonstrated in both an ex
vivo study4 of human skin samples and an in-situ study
of the volar forearms of healthy volunteers.2
In a randomized, multicenter, evaluator-blinded, controlled
pivotal clinical study, 58% (73/125) and 56% (69/124) of patients
treated with SKINVIVE™ by JUVÉDERM® saw a ≥ 1 point
improvement on the Allergan Cheek Smoothness Scale (ACSS) at one
month and six months respectively. In a patient reported
satisfaction with skin questionnaire, 63% (78/124) of patients were
satisfied with how radiant their facial skin looked at six months
compared with 11% before treatment. At six months, 72% were
satisfied with how hydrated their facial skin looked at six months
compared to 24% before treatment. Additionally, 69% (86/124) were
satisfied with how refreshed their facial skin made them look at
six months compared to 16% before treatment. At month six, 83%
(103/124) were satisfied with how healthy their facial skin looked
compared to 38% before treatment.
The majority of subjects in the clinical study reported
experiencing side effects such as redness, lumps/bumps, swelling,
bruising, tenderness, pain, firmness, discoloration, and itching at
the injection sites, as reported in their 30-day daily diaries.
These side effects were usually mild (causing little discomfort and
no effect on daily activities) or moderate (causing some discomfort
and effect on daily activities) in severity, although a few
participants experienced severe side effects (causing great
discomfort and effect on daily activities). Investigators also
reported needle abrasion and papule at the injection site. While
rare, some participants experienced side effects that lasted longer
than 30 days; however, most side effects went away on their own
within 30 days.1
Consumers and new patients who receive aesthetic treatment from
the Allergan Aesthetics portfolio of products 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 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.
As sometimes happens with novel products, the FDA has required
that Allergan Aesthetics provide a training program for all
interested providers. Successful completion of this training is
necessary prior to purchase of and administration of SKINVIVE™ by
JUVÉDERM®.
Allergan Aesthetics anticipates that SKINVIVE™ by
JUVÉDERM® will be broadly commercially available within
the next six months. To learn more about SKINVIVE™ by
JUVÉDERM® visit www.skinvivebyjuvederm.com and follow
@SKINVIVEbyJUVEDERM 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.
SKINVIVE™ by JUVÉDERM® Injectable Gel
Important Information
APPROVED USES
SKINVIVE™ by JUVÉDERM®
injectable gel is an injection to improve skin smoothness of the
cheeks in adults over the age of 21.
IMPORTANT SAFETY INFORMATION
Are there any reasons why I should not receive SKINVIVE™ by
JUVÉDERM® treatment?
Do not use this product if you have a history of multiple severe
allergies or severe allergic reactions (anaphylaxis), if you are
allergic to lidocaine or the Gram-positive bacterial proteins used
in this product, or if you have had previous allergic reactions to
hyaluronic acid fillers.
What Warnings should my specialist advise me about?
- One of the risks with dermal filler injection 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. Tell
your specialist immediately 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
- The use of this product 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 specialist advise me
about?
- Minimize strenuous exercise, exposure to extensive sun or heat,
and alcoholic beverages 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 specialist if you are using any medication that can
prolong bleeding, such as aspirin, ibuprofen, or other blood
thinners, as this may increase bruising or bleeding at the
injection site
- Tell your specialist if you are planning laser treatment,
chemical peeling, or any other procedure after SKINVIVE™ by
JUVÉDERM®. There is a possible risk of an inflammatory
reaction at the treatment site
- This product is intended for improving skin smoothness of the
cheeks. The safety and effectiveness for treatment in other areas
of the body have not been established
- Tell your specialist if you are on therapy used to decrease the
body's immune response, as treatment may result in an increased
risk of infection
- Tell your specialist if you are pregnant or breastfeeding. The
safety for use during pregnancy, or in women who are breastfeeding,
has not been studied
- Tell your specialist if you have a history of excessive
scarring (thick, hard scars). The safety of this product in
patients with a history of excessive scarring has not been studied
and may result in additional scars
- Tell your specialist if you have a history of pigmentation
disorders, as use of this product in patients with a history of
pigmentation disorders has not been studied and may result in
changes in pigmentation
What are the possible side effects of treatment?
The
most commonly reported side effects were redness, lumps/bumps,
swelling, bruising, pain, tenderness, firmness, discoloration and
itching. Most side effects will resolve within 7 days. If they
persist longer, your physician may choose to treat them with
medications, such as antibiotics, steroids, or hyaluronidase.
Additionally, there have been reports of inflammation, nodules,
unsatisfactory result, loss or lack of improvement, allergic
reaction, anxiety, blood vessel blockage, infection, dry skin,
increase or decrease in sensation, and abscess.
Delayed-onset inflammation near the site of dermal filler
injections is one of the known adverse events associated with
dermal fillers. As with all skin injection procedures, there is a
risk of infection.
To report a side effect, please call the Allergan®
Product Support Department at 1-877-345-5372. Please also visit
skinvivebyjuvederm.com or talk to your specialist for more
information.
SKINVIVE™ by JUVÉDERM® is available only by a
licensed physician or properly licensed practitioner.
References
- SKINVIVE™ by JUVÉDERM® Patient Label 2023.
- Safa M., Natalizio A., Hee, CK. A Prospective, Open-Label Study
to Evaluate the Impact of VYC-12L Injection on Skin Quality
Attributes in Healthy Volunteers. Clinical, Cosmetic and
Investigational Dermatology. 2022.
- SKINVIVE™ by JUVÉDERM® Directions for Use 2023.
- Nakab L., Hee CK, Guetta O. Improvements in Skin Quality
Biological Markers in Skin Explants Using Hyaluronic Acid Filler
VYC-12L. Plastic Reconstr Surg Glob Open. 2020.
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SOURCE AbbVie