DUBLIN, March 22, 2017 /PRNewswire/ -- Allergan plc
(NYSE: AGN) today announced the availability of RESTASIS
MULTIDOSE™, which is the same preservative-free RESTASIS®
formulation, but now offered in a multidose bottle. RESTASIS® is
the first and only prescription medication FDA-approved to help
patients with a type of Chronic Dry Eye make more of their own
tears. RESTASIS MultiDose™ is the first and only FDA-approved
preservative-free, prescription eye drop in the U.S. to be
available in a multidose bottle. RESTASIS® was accessible only in
single-use vials, since its launch in 2003 until now.
RESTASIS® helps increase your eyes' natural ability to produce
tears, which may be reduced by inflammation due to Chronic Dry Eye.
RESTASIS® did not increase tear production in patients using
anti-inflammatory eye drops or tear duct plugs.
"Since RESTASIS MultiDose™ is the only FDA-approved
preservative-free prescription eye drop in the U.S. to be offered
in a multidose bottle, patients now have a choice of a multidose
bottle or single-use vials," said Neda Shamie, MD, of Advanced
Vision Care, in Los Angeles, Calif.
RESTASIS MULTIDOSE™ is designed with a patented unidirectional
valve and air filter technology. The new multi-dose bottle uses
less plastic than a package of single-use vials and will be
available for the same price.
"We are continuously looking to improve patient care through
state-of-the-art product engineering, and RESTASIS MULTIDOSE™
reflects that commitment," said David
Nicholson, Chief R&D Officer at Allergan. "This
new multi-dose bottle is designed to maintain the preservative-free
formulation."
Allergan offers eligible RESTASIS MultiDose™ patients a savings
program called My Tears, My Rewards® which helps patients save on
each prescription. For more information on the savings
program and to determine eligibility, visit
www.Restasis.com/savings or call 844-4MY-TEARS.
About Chronic Dry Eye
One type of chronic dry eye is
caused by reduced tear production due to inflammation. Dry eye is
often a chronic disease that can be caused by advanced age, contact
lens wear, certain medications, eye diseases, other medical
conditions or environmental factors. Without enough tears, the film
protecting the eye can break down, creating dry spots on the
cornea.
About RESTASIS
RESTASIS® and RESTASIS MULTIDOSE™
Ophthalmic Emulsion help increase your eyes' natural ability to
produce tears, which may be reduced by inflammation due to Chronic
Dry Eye. RESTASIS® and RESTASIS MULTIDOSE™ did not increase tear
production in patients using anti-inflammatory eye drops or tear
duct plugs.
About RESTASIS MULTIDOSE™
Important Safety
Information
Do not use RESTASIS® and RESTASIS MULTIDOSE™ Ophthalmic Emulsion if
you are allergic to any of the ingredients. Be careful not to
touch the container tip to your eye or other surfaces, to help
avoid eye injury and contamination. RESTASIS® and RESTASIS
MULTIDOSE™ should not be used while wearing contact lenses. If
contact lenses are worn, they should be removed prior to use of
RESTASIS® and RESTASIS MULTIDOSE™ and may be reinserted after 15
minutes.
The most common side effect is a temporary burning sensation.
Other side effects include eye redness, discharge, watery eyes, eye
pain, foreign body sensation, itching, stinging, and blurred
vision.
Indications and Usage
RESTASIS® and RESTASIS
MULTIDOSE™ ophthalmic emulsion are indicated to increase tear
production in patients whose tear production is presumed to be
suppressed due to ocular inflammation associated with
keratoconjunctivitis sicca. Increased tear production was not seen
in patients currently taking topical anti-inflammatory drugs or
using punctal plugs.
Important Safety
Information
Contraindications
RESTASIS® and
RESTASIS MULTIDOSE™ are contraindicated in patients with known or
suspected hypersensitivity to any of the ingredients in the
formulation.
Warnings and Precautions
Potential for Eye Injury
and Contamination: Be careful not to touch the container tip to
your eye or other surfaces to avoid potential for eye injury and
contamination.
Use With Contact Lenses: RESTASIS® and RESTASIS
MULTIDOSE™ should not be administered while wearing contact lenses.
If contact lenses are worn, they should be removed prior to the
administration of the emulsion. Lenses may be reinserted 15 minutes
following administration of RESTASIS® and RESTASIS MULTIDOSE™
ophthalmic emulsion.
Adverse Reactions
In clinical trials, the most common
adverse reaction following the use of cyclosporine ophthalmic
emulsion 0.05% was ocular burning (upon instillation)—17%. Other
reactions reported in 1% to 5% of patients included conjunctival
hyperemia, discharge, epiphora, eye pain, foreign body sensation,
pruritus, stinging, and visual disturbance (most often
blurring).
For Restasis® and Restasis Multidose™ full prescribing
information, visit www.allergan.com/assets/pdf/restasis_pi and
https://www.allergan.com/assets/pdf/restasis-multidose_pi.
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,
2016. Except as expressly required by law, Allergan
disclaims any intent or obligation to update these forward-looking
statements.
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SOURCE Allergan plc