DUBLIN, Oct. 18, 2016
/PRNewswire/ -- Allergan plc, (NYSE: AGN), a leading global
pharmaceutical company, announced today that the latest addition to
the JUVÉDERM® collection of fillers, JUVÉDERM VOLBELLA® XC, is now
available to physicians and patients for use in the lips for lip
augmentation and for correction of perioral rhytids, commonly
referred to as "lipstick lines", in adults over the age of
21.1 In clinical trials, JUVÉDERM VOLBELLA® XC was found
to effectively increase lip fullness and soften the appearance of
lines around the mouth in a majority of subjects through one
year.1,2* JUVÉDERM VOLBELLA® XC is the only filler
proven to last through one year in both the lips and perioral
rhytids with optimal treatment.2
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"Our physician customers have told us perioral lines are
difficult to treat and are also a top concern among patients," said
David Moatazedi, Senior Vice
President US Medical Aesthetics. "We developed a soft, smooth
gel appropriate for adding subtle volume to the lips and softening
the appearance of perioral lines to address this specific
need. We are committed to providing our doctors with products
to address the evolving needs of their aesthetically-oriented
patients."
According to the American Society of Plastic Surgeons (ASPS),
use of soft tissue fillers in 2015 was the fastest growing cosmetic
minimally-invasive procedure.3 JUVÉDERM VOLBELLA® XC is
approved specifically for the lips and perioral rhytids. JUVÉDERM
VOLBELLA® XC is formulated with VYCROSS®,2 a proprietary
filler technology from Allergan, which yields smooth products that
have been engineered to address specific patient
concerns.4 " The most common side effects observed in
clinical trials were temporary responses at the treatment site such
as swelling, tenderness, bruising, firmness lumps/bumps, redness,
pain, discoloration, itching and dryness. Most of these side
effects resolved within 30 days.2
JUVÉDERM VOLBELLA® XC is now available for purchase by
physicians who have completed an online training program.
Physicians can find information about injection technique and
complete the online training by visiting
www.VolbellaTraining.com.
Consumers can learn more about JUVÉDERM VOLBELLA® XC
and the JUVÉDERM® collection of fillers or find a doctor
in their area by visiting www.juvederm.com.
JUVÉDERM VOLBELLA® XC Important Information
APPROVED USES
JUVÉDERM VOLBELLA® XC injectable gel is
for injection into the lips for lip augmentation and for correction
of perioral lines in adults over the age of 21.
IMPORTANT SAFETY INFORMATION
Are there any reasons why I should not receive JUVÉDERM
VOLBELLA® XC injectable gel?
Do not use this product
if you have a history of multiple severe allergies or severe
allergic reactions (anaphylaxis), or if you are allergic to
lidocaine or Gram-positive bacterial proteins used in these
products.
What precautions should my doctor advise me about?
- Tell your doctor if you are pregnant or breastfeeding. The
safety of JUVÉDERM VOLBELLA® XC for use during pregnancy or while
breastfeeding has not been studied
- The safety of JUVÉDERM VOLBELLA® XC in patients under 22 years
has not been studied
- The safety and effectiveness of JUVÉDERM VOLBELLA® XC in areas
other than the lips and perioral area have not been established in
controlled clinical studies
- Tell your doctor if you have a history of excessive scarring
(eg, hypertrophic scarring and keloid formations) or pigmentation
disorders, as use of JUVÉDERM VOLBELLA® XC may result in additional
scars or changes in pigmentation
- Tell your doctor if you are planning other laser treatments or
a chemical peel, as there is a possible risk of inflammation at the
treatment site if these procedures are performed after
treatment
- Patients who experience skin injury near the site of injection
with this product may be at a higher risk for side effects
- Tell your doctor if you are on immunosuppressive therapy used
to decrease the body's immune response, as use of JUVÉDERM
VOLBELLA® XC may result in an increased risk of infection
- Tell your doctor if you are using medications that can prolong
bleeding, such as aspirin, ibuprofen, or other blood thinners, as
this may result in increased bruising or bleeding at the injection
site
- Minimize strenuous exercise, exposure to extensive sun or heat,
and alcoholic beverages within the first 24 hours following
treatment
What are possible side effects?
The most common side
effects include swelling, tenderness, bruising, firmness,
lumps/bumps, redness, pain, discoloration, itching, and dryness.
Most side effects are mild or moderate and last 30 days or
less.
One of the risks with using this product is unintentional
injection into a blood vessel, and, while rare, 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.
As with all skin injection procedures, there is a risk of
infection.
To report a side effect with JUVÉDERM VOLBELLA® XC,
please call Allergan at 1-800-433-8871. Please also
visit Juvederm.com for more information.
Available by prescription only.
© 2016 Allergan. All rights reserved. All trademarks are the
property of their respective owners.
References:
1. JUVÉDERM
VOLBELLA® XC Directions for Use, 2016.
2. JUVÉDERM VOLBELLA® XC Patient Labeling,
2016.
3. American Society of Plastic Surgeons 2015 National
Clearinghouse of Plastic Surgery Procedural Statistics, 2015. "2015
Cosmetic Plastic Surgery Statistics Cosmetic Procedure Trends."
4. Data on File VYCROSS™: An Innovative Dermal Filler
Technology, 2013.
About Allergan plc
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a bold, global
pharmaceutical company and a leader in a new industry model –
Growth Pharma. Allergan is focused on developing,
manufacturing and commercializing branded pharmaceuticals, devices
and biologic products for patients around the world.
Allergan markets a portfolio of leading brands and best-in-class
products for the central nervous system, eye care, medical
aesthetics and dermatology, gastroenterology, women's health,
urology and anti-infective therapeutic categories.
Allergan is an industry leader in Open Science, the Company's
R&D model, which defines our approach to identifying and
developing game-changing ideas and innovation for better patient
care. This approach has led to Allergan building one of the
broadest development pipelines in the pharmaceutical industry with
70+ mid-to-late stage pipeline programs in development.
Our Company's success is powered by our more than 16,000 global
colleagues' commitment to being Bold for Life. Together, we
build bridges, power ideas, act fast and drive results for our
customers and patients around the world by always doing what is
right.
With commercial operations in approximately 100 countries,
Allergan is committed to working with physicians, healthcare
providers and patients to deliver innovative and meaningful
treatments that help people around the world live longer, healthier
lives every day.
For more information, visit Allergan's website at
www.Allergan.com.
Forward-Looking Statement
Statements contained in this press release that refer to future
events or other non-historical facts are forward-looking statements
that reflect Allergan's current perspective of existing trends and
information as of the date of this release. Except as expressly
required by law, Allergan disclaims any intent or obligation to
update these forward-looking statements. Actual results may differ
materially from Allergan's current expectations depending upon a
number of factors affecting Allergan's business. These factors
include, among others, the difficulty of predicting the timing or
outcome of FDA approvals or actions, if any; the impact of
competitive products and pricing; market acceptance of and
continued demand for Allergan's products; difficulties or delays in
manufacturing; and other risks and uncertainties detailed in
Allergan's periodic public filings with the Securities and Exchange
Commission, including but not limited to Allergan's Annual Report
on Form 10-K for the year ended December 31,
2015 and Quarterly Report on Form 10-Q for the quarter ended
June 30, 2016 (such periodic public
filings having been filed under the "Actavis plc" name). Except as
expressly required by law, Allergan disclaims any intent or
obligation to update these forward-looking statements.
CONTACTS:
Investors:
Lisa DeFrancesco
(862) 261-7152
Media:
Mark Marmur
(862) 261-7558
Ember Garrett
(714) 246-3525
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SOURCE Allergan plc