DUBLIN, May 16, 2016 /PRNewswire/ -- Allergan plc (NYSE:
AGN) announced today that two pivotal trials of the Oculeve
Intranasal Tear Neurostimulator, OCUN-009 and OCUN-010, each met
their primary and secondary efficacy endpoints. With these new
results, a premarket submission for the device is on-track to be
submitted to the Food and Drug Administration (FDA) in the second
half of 2016.
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This handheld stimulator and daily disposable tips increases
tear production upon stimulation in patients with Dry Eye Disease
due to decreased tear production. There have been several Oculeve
Intranasal Tear Neurostimulator clinical studies completed with
more than 200 adult patients, showing positive safety and efficacy
of the device.
"We are excited with the outcome of these two sets of pivotal
data," said David Nicholson, Chief
R&D Officer, at Allergan. "The Oculeve Intranasal Tear
Neurostimulator is a novel approach and has the potential to help
patients suffering from dry eye by increasing their natural tears.
This device is part of Allergan's strong eye care development
pipeline and will complement our leading dry eye treatment
RESTASIS®. This is a major step forward in providing a promising
new option for eye care professionals and their patients with dry
eye disease."
About the Studies
The OCUN-009 study is a prospective, randomized, controlled,
double-masked, multicenter, cross-over trial in which participants
used an active device and two control applications. The
primary effectiveness endpoint of increased tear production over
basal during intranasal application as measured by Schirmer score
compared to both controls was met. The OCUN-010 study design is a
prospective, single-arm, multicenter, open-label clinical trial in
which participants used the Oculeve Intranasal Tear Neurostimulator
to stimulate tear production for 180 days. The primary
effectiveness endpoint of increased tear production as measured by
Schirmer score during application of the device compared with basal
Schirmer score at Day 180 was met. Secondary endpoints of
increased tear production as measured by Schirmer score during
application of the device compared with basal Schirmer score at
Days 0, 7, 30 and 90 were also met. All device-related
adverse events were mild in nature. There were no
device-related serious adverse events. No patients discontinued
treatment due to adverse events.
About Chronic Dry Eye Disease
Chronic dry eye is a disease that affects over 25 million
people. It 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.
The Oculeve Intranasal Tear Neurostimulator is limited
by United States law
to investigational use.
About Allergan
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a unique, global
pharmaceutical company and a leader in a new industry model –
Growth Pharma. Allergan is focused on developing,
manufacturing and commercializing innovative branded
pharmaceuticals, high-quality generic and over-the-counter
medicines and biologic products for patients around the world.
Allergan markets a portfolio of best-in-class products that
provide valuable treatments for the central nervous system, eye
care, medical aesthetics, gastroenterology, women's health,
urology, cardiovascular and anti-infective therapeutic categories,
and operates the world's third-largest global generics business,
providing patients around the globe with increased access to
affordable, high-quality medicines. Allergan is an industry leader
in research and development, with one of the broadest development
pipelines in the pharmaceutical industry and a leading position in
the submission of generic product applications globally.
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.
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 Quarterly
Report on Form 10-Q for the quarter ended March 31,
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
(973) 906-1526
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SOURCE Allergan plc