DUBLIN, April 13, 2018 /PRNewswire/ -- Allergan plc,
(NYSE: AGN), a leading global pharmaceutical company, today
announced the official launch of TrueTear®, the first
and only FDA-cleared device developed to temporarily increase
tear production during neurostimulation in adult patients.
TrueTear®, a handheld neurostimulation device with
disposable tips that is inserted into the nasal cavity to induce
the production of natural tears, is a novel and innovative approach
for those patients with inadequate tear production. In two clinical
trials, TrueTear® was shown to be safe and effective for
temporarily increasing tear production in adult patients.
The neurostimulation device will be officially launched during
the 2018 American Society of Cataract and Refractive Surgery and
American Society of Ophthalmic Administrators annual meetings being
held April 13-17 in Washington, DC.
"TrueTear® is the latest in a long line of
innovations that have helped make Allergan a leading global eye
care company. We are excited to add this drug-free, drop-free
treatment option for adult patients with inadequate tear production
to our current portfolio. This milestone truly represents our
company's ongoing commitment to developing eye care products that
help improve the lives of patients," said Jag Dosanjh, Senior Vice
President, US Eye Care. "For more than 70 years, Allergan has
remained focused on delivering the most innovative eye care
products in the industry. TrueTear® continues the proud
heritage of our foundational philosophy: to bring innovative
treatments to patients around the world."
"As seen in clinical trials and in my own post-approval
experience treating patients, TrueTear® provides tiny
pulses of energy within the nasal cavity to create tears and may be
appropriate for most patients with inadequate tear production,"
said John Sheppard, M.D., M.M. Sc.,
F.A.C.S., Professor of Ophthalmology, Eastern
Virginia Medical School and President of Virginia Eye
Consultants in Norfolk, Virginia.
"TrueTear® is the first device of its kind, providing a
temporary increase in tear production with neurostimulation,
thereby returning the ocular surface to a more normal physiologic
state without prescribing drops or surgery."
Allergan: 70 Years Advancing Eye Care
As a leader in
eye care, Allergan has discovered, developed, and delivered some of
the most innovative products in the industry over the last 70
years. Allergan has launched over 125 eye care products and
invested billions of dollars in new treatments for the most
prevalent eye conditions including glaucoma, ocular surface
disease, and retinal diseases such as diabetic macular edema and
retinal vein occlusion. Our eye care pipeline includes 13
additional agents for multiple ocular conditions.
Our commitment to the well-being of patients is also reflected
in philanthropy. Allergan and The Allergan Foundation support more
than 150 organizations around the world working to improve lives
and communities. We remain steadfast in helping eye care
providers deliver the best in patient care through innovative
products and outreach programs.
The TrueTear® device is a prescription-only device.
Adult patients with dry eye should consult with their eye care
professional about TrueTear®.
TrueTear® Important Information
ABOUT TRUETEAR
INDICATION
TrueTear® provides a
temporary increase in tear production during neurostimulation in
adult patients.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
Do not prescribe TrueTear® to patients with a cardiac
pacemaker, implanted or wearable defibrillator, or other implanted
metallic or electronic device within head or neck; a known
hypersensitivity to the hydrogel device material; or chronic or
recurrent nosebleeds, or bleeding disorder/condition that can lead
to increased bleeding.
WARNINGS
Do not apply stimulation around electronic
monitoring equipment (eg, cardiac monitors, ECG alarms), in the
bath/shower, while driving, operating machinery, during activity in
which sneezing/watery eyes may cause risk, areas other than the
nose, within 3 feet of shortwave or microwave therapy equipment,
around flammable anesthetics mixture (air, oxygen or nitrous
oxygen). Persistent use on irritated nasal tissue may cause injury.
Safety/effectiveness not established for longer than 6 months or
for treating aqueous-deficient dry eye disease. Safety not
established in pregnancy, patients under 22 years of age, patients
with nasal or sinus surgery (including nasal cautery) or
significant trauma; severe nasal airway obstruction or vascularized
polyp; active, severe systemic or chronic seasonal allergies;
rhinitis or sinusitis requiring treatment; untreated nasal
infection; and disabling arthritis, neuropathy, severe dexterity
impairment or limited motor coordination.
PRECAUTIONS
Consult patients to discontinue use
if pain, discomfort or numbness in the nose persists after
adjusting for high levels/long sessions; to remove studs, nose
rings, or other nose jewelry before use; to not use prescription
eye medications or nasal sprays 30 minutes before or after using
TrueTear®. Suspected or diagnosed heart disease patients
should follow doctor's precautions. Keep away from children.
ADVERSE EVENTS
Nasal pain, discomfort or
burning (10.3%); transient electrical discomfort (5.2%); nosebleed
(5.2%); nasal congestion (3.1%); headaches (2.1%); trace blood, dot
heme in nostril (2.1%); facial pain (2.1%); sore eye (1.0%); sinus
pain (1.0%); periorbital pain (1.0%); runny nose (1.0%); nasal
ulcers (1.0%); and light-headedness (1.0%).
Caution: Federal law restricts this device to sale by or on the
order of a licensed physician. For the full Directions for Use,
please visit www.allergan.com/truetear/usa.htm or call
1-800-678-1605. Please call 1-800-433-8871 to report an adverse
event.
About Allergan plc
Allergan plc (NYSE: AGN),
headquartered in Dublin, Ireland,
is a bold, global pharmaceutical leader. Allergan is 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 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, a model of
research and development, which defines our approach to identifying
and developing game-changing ideas and innovation for better
patient care. With this approach, Allergan has built one of the
broadest development pipelines in the pharmaceutical industry.
Allergan's success is powered by our 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 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; uncertainty
associated with financial projections, projected cost reductions,
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, 2017.
Except as expressly required by law, Allergan disclaims any intent
or obligation to update these forward-looking statements.
CONTACTS:
Allergan:
Investors:
Daphne Karydas
(862) 261-8006
Media:
Amy Rose
(862) 261-7001
Lisa Kim
(714) 246-3843
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SOURCE Allergan plc