DUBLIN, Sept. 3, 2019 /PRNewswire/ -- Allergan plc (NYSE:
AGN) announced today it received U.S. Food and Drug Administration
(FDA) approval for the use of Juvéderm VOLUMA® XC, a
hyaluronic acid gel dermal filler, with a TSK STERiGLIDE™ cannula
for cheek augmentation to correct age-related volume deficit in the
mid-face in adults over 21. A cannula is a thin, flexible tube with
a rounded tip that can serve as an effective delivery system. Use
of a cannula allows for injection of Juvéderm VOLUMA® XC
in the cheek area. The TSK STERiGLIDE™ has a unique design compared
to other cannulas available on the market and features a patented
tip design with a near-tip delivery port for precise product
placement.
"As a physician, I have used the Juvéderm Collection of Fillers
for 13 years, so I am thrilled that the FDA has approved the use of
cannula with Juvéderm VOLUMA® XC for mid-face volume
deficit. With this latest approval, I have another effective option
to provide volume and contour in the mid-face area. I can tailor my
treatment approach for each patient while safely providing the
aesthetic outcomes they wish to achieve," says Dr. Dee Anna Glaser, a board-certified dermatologist
in St. Louis and clinical trial
investigator.
"At Allergan, we are committed to driving innovation in medical
aesthetics as well as providing best-in-class injector training to
our customers," says Carrie Strom,
Senior Vice President of U.S. Allergan Medical Aesthetics. "With
this approval, Allergan will be able to educate on facial anatomy
and injection techniques that will help healthcare providers
administer treatment with Juvéderm VOLUMA® XC safely to
achieve optimal patient satisfaction."
A multicenter, split-face, investigator-blinded, non-inferiority
study was performed to assess the safety and effectiveness of
Juvéderm VOLUMA® XC for correction of age-related volume
deficit in the mid-face with the use of a TSK STERiGLIDE™ cannula
versus a needle. The 12-week study took place in seven sites across
the U.S. with 60 subjects. All subjects completed the study.
Results demonstrated comparable performance, safety profile and
patient satisfaction between cannula and needle injection.
Within the Juvéderm Collection of Fillers, this is the first
approval for the use of cannula. Juvéderm VOLUMA® XC was
first approved by the FDA in 2013 and is formulated with Allergan's
proprietary VYCROSS® technology, which blends different
molecular weights of hyaluronic acid, contributing to the gel's
duration and is proven to last in the mid-face area for up to 24
months with optimal treatment. Juvéderm VOLUMA® XC is
currently the best-selling Juvéderm product in the US.
For more information about the
Juvéderm® Collection of Fillers please visit
www.juvederm.com.
About Allergan plc
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a global pharmaceutical
leader focused on developing, manufacturing and commercializing
branded pharmaceutical, device, biologic, surgical and regenerative
medicine products for patients around the world. Allergan markets a
portfolio of leading brands and best-in-class products primarily
focused on four key therapeutic areas including medical aesthetics,
eye care, central nervous system and gastroenterology. As part of
its approach to delivering innovation for better patient care,
Allergan has built one of the broadest pharmaceutical and device
research and development pipelines in the industry.
With colleagues and commercial operations located 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 on existing trends and
information as of the date of this release. 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; the impact of uncertainty
around timing of generic entry related to key products, including
RESTASIS®, on our financial results; risks associated
with divestitures, acquisitions, mergers and joint ventures; risks
related to impairments; uncertainty associated with financial
projections, projected cost reductions, projected debt reduction,
projected synergies, restructurings, increased costs, and adverse
tax consequences; 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, 2018
and Allergan's Quarterly Report on Form 10-Q for the period ended
June 30, 2019. Except as expressly
required by law, Allergan disclaims any intent or obligation to
update these forward-looking statements.
Important Safety Information about
Juvéderm VOLUMA® XC
INDICATION
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 in adults over the age of 21.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
This product 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 this
product.
WARNINGS
- Do not inject into blood vessels. Introduction of this product
into the vasculature may lead to embolization, occlusion of the
vessels, ischemia or infarction. Take extra care when injecting
soft-tissue fillers; for example, 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
- In order to minimize the risk of potential complications, this
product should only be used by healthcare professionals who have
appropriate training, experience, and knowledge of facial
anatomy
- Healthcare professionals are encouraged to discuss the
potential risks of soft-tissue injections with their patients prior
to treatment and ensure that patients are aware of signs and
symptoms of potential complications
- The safety and effectiveness for the treatment of anatomic
regions other than the mid-face have not been established in
controlled clinical studies
- The safety for use during pregnancy and in breastfeeding
females has not been established
- The safety for use in patients under 35 or over 65 years has
not been established
- As with all transcutaneous procedures, dermal filler
implantation carries a risk of infection. Follow standard
precautions associated with injectable materials
- The safety for use in patients with known susceptibility to
keloid formation, hypertrophic scarring, and pigmentation disorders
has not been studied
- Use with caution in patients on immunosuppressive therapy
- Patients who are using products 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
- The safety for use in patients with very thin skin in the
mid-face has not been established
- Patients may experience late onset nodules with use of dermal
fillers including JUVÉDERM VOLUMA® XC
ADVERSE EVENTS
Side effects in > 5% of subjects
were temporary injection-site tenderness, swelling, firmness,
lumps/bumps, bruising, pain, redness, discoloration, and itching.
They were predominantly moderate in severity, with a duration of 2
to 4 weeks.
To report an adverse reaction, please call Allergan Product
Surveillance at 1-877-345-5372.
For more information, please see JuvedermDFU.com or call the
Allergan Medical Information line at 1-800-433-8871.
JUVÉDERM VOLUMA® XC injectable gel is available by
prescription only.
CONTACTS:
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Allergan
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Investors:
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Manisha Narasimhan,
PhD
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(862)
261-7162
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Christine
Chiou
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(862)
261-7396
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Media:
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Lisa Brown
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(862)
261-7320
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Ember
Garrett
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(714)
246-3525
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SOURCE Allergan plc