DUBLIN, June 13, 2018 /PRNewswire/ -- Allergan plc,
(NYSE: AGN), a leading global pharmaceutical company, today
announced the release of new topline clinical trial data on
Bimatoprost SR, the first-in-class sustained-release, biodegradable
implant for the reduction of intraocular pressure (IOP) in patients
with open-angle glaucoma or ocular hypertension. Bimatoprost SR is
designed to lower IOP for at least 4 months, achieving clinical
goals while freeing patients from daily eye drop regimens.
In this first Phase 3 clinical study of 594 subjects with
open-angle glaucoma or ocular hypertension, Bimatoprost SR reduced
IOP by approximately 30 percent over the 12-week primary efficacy
period, meeting the predefined criteria for non-inferiority to the
study comparator, timolol. This initial data showed the potential
for the majority of patients to remain treatment free for one year
after the last implant was inserted. The magnitude of IOP
lowering efficacy with Bimatoprost SR observed in this study is
similar to that observed with daily topical prostaglandin
analogues. Bimatoprost SR was also well tolerated in the majority
of patients. Additional safety data from this study and results
from a second Phase 3 study with an identical design will be
reported in the first half of 2019. An NDA filing to the FDA is
expected in the second half of 2019.
"Effective sustained-release, IOP-lowering medication has been
an aspiration of the glaucoma specialty for many years," said
David Nicholson, Chief Research and
Development Officer, Allergan. "In Allergan's long history of
innovative treatments for glaucoma and other eye diseases, this
first-in-class Bimatoprost SR data represents a major milestone of
which we are very proud."
"Bimatoprost SR has the potential to be the first
sustained-release option of a drop-free therapy for patients who
are suffering from glaucoma. This is a real potential paradigm
shift in our options to lower eye pressure in patients with
glaucoma," said Randy Craven, MD,
Chief, Wilmer Eye Institute at Bethesda,Vice Chair of Wilmer
Practice Network and Associate Professor at Johns Hopkins University School of
Medicine.
"Considering that as many as 80 percent of glaucoma patients
fail to administer their drops on a regular basis, Bimatoprost SR
has the potential to transform the management of glaucoma in
millions of patients. Allergan's deep glaucoma heritage provides a
strong platform to bring Bimatoprost SR to physicians and their
patients," said Bill Meury, Chief
Commercial Officer, Allergan.
About the Bimatoprost Study Design
This multicenter, randomized, masked, parallel-group study in
patients with open angle glaucoma or ocular hypertension compares
the efficacy and safety of 2 dose strengths of Bimatoprost SR
(after single and repeat administrations) to timolol eye drops used
twice daily for up to 20 months. The patients are randomized
to receive 3 administration cycles (Day 1, Week 16 and Week 32) of
Bimatoprost SR or twice daily timolol eye drops in the study eyes.
Vehicle eye drops or sham administrations (Day 1, Week 16 and Week
32) are used in the study eyes for masking purposes.
About Glaucoma and Long-Term Medication Compliance
Glaucoma is one of the primary causes of irreversible vision
loss and blindness. In 2010, 60.5 million people in the world were
living with glaucoma, a number that is expected to rise to nearly
80 million by 2020. This progressive disease is characterized by
elevated IOP. Uncontrolled, elevated IOP causes damage to the optic
nerve and loss of vision. Reduction of elevated IOP is the only
effective way to stop progression and vision loss associated with
glaucoma.
Current treatments to lower IOP include topical medications (eye
drops), laser trabeculoplasty, minimally invasive glaucoma surgery
(MIGS), and incisional surgery. Eye drop medications are the
standard first-line treatment for glaucoma, but low patient
adherence to these medications is common – up to 80 percent of
patients are not using topical medications as prescribed. Patients
often find it difficult to adhere to their eye drop regimen every
day, year after year, because they forget to take doses, cannot
afford medications, do not understand their disease, or have
trouble instilling eye drops or sticking to the schedule. Poor
adherence to topical medications relates directly to disease
progression and vision loss. To remove long-term eye drop
compliance as a factor in preserving vision, ophthalmologists rely
on laser trabeculectomy, MIGS & more invasive incisional
surgeries and await the development of sustained-release
medication.
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.
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; risks associated
with divestitures, acquisitions, mergers and joint ventures;
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 and Allergan's Quarterly Report on Form 10-Q for the
period ended March 31, 2018. 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
Karina Calzadilla
(862) 261-7328
Media:
Amy Rose
(862) 289-3072
Fran DeSena
(862) 261-8820
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