DUBLIN, July 17, 2019 /PRNewswire/ -- Allergan plc (NYSE:
AGN), a leading global pharmaceutical company with more than 70
years of heritage in eye care, today announced that the U.S. Food
and Drug Administration (FDA) has accepted the company's New Drug
Application (NDA) for Bimatoprost Sustained-Release (SR).
Bimatoprost SR if approved would be the first-in-class
sustained-release, biodegradable implant for the reduction of
intraocular pressure in patients with primary open-angle glaucoma
or ocular hypertension. The FDA is expected to take action on the
NDA by the end of the first half of 2020.
"With decades of experience researching and introducing
innovative eye care treatments, we understand the importance of
developing new and potentially sight-saving treatments for patients
with glaucoma," said David
Nicholson, Chief Research and Development Officer, Allergan.
"The NDA is based on the positive results from the ARTEMIS Phase 3
studies and demonstrates our ongoing commitment to providing new
treatments for patients living with glaucoma."
In the two Phase 3 ARTEMIS studies, Bimatoprost SR reduced
intraocular pressure (IOP) by 30 percent over the 12-week primary
efficacy period, meeting the predefined criteria for
non-inferiority to the study comparator. The ARTEMIS studies
evaluated 1,122 subjects on the efficacy and safety of Bimatoprost
SR versus timolol, a FDA standard comparator for registrational
clinical trials, in patients with open-angle glaucoma or ocular
hypertension. After 3 treatments with Bimatoprost SR, greater than
80 percent of patients remained treatment free and did not need
additional treatment to maintain IOP control for at least 12
months. Bimatoprost SR was well tolerated in the majority of
patients.
"Millions of people are living with glaucoma, a progressive
disease that requires sustained IOP control to preserve vision for
patients," said Robert Weinreb,
M.D., Chairman & Distinguished Professor of Ophthalmology and
Director of the Shiley Eye Institute, San
Diego. "Data from the ARTEMIS trials show Bimatoprost SR
lowers IOP and maintains that effect for the majority of patients
for one year after three administrations of the implant.
Bimatoprost SR has the potential to be the first sustained-release
option that could significantly shift the paradigm for treating
glaucoma, a leading cause of blindness."
About Glaucoma and Long-Term Medication Compliance
Glaucoma is one of the primary causes of irreversible vision
loss and blindness. In 2018, nearly 130 million people were living
with glaucoma globally. This number is expected to rise to an
estimated 148 million by 2023. 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 proven way to slow the progression and vision loss
associated with glaucoma.
Current treatments to lower IOP include topical medications (eye
drops), laser trabeculoplasty, minimally invasive glaucoma surgery
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 adherence as a factor in
preserving vision, ophthalmologists rely on laser trabeculoplasty,
minimally invasive glaucoma surgery (MIGS) and more invasive
incisional surgeries and await the development of sustained-release
medication.
About Allergan 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 social responsibility. Allergan, The Allergan Foundation and The
Allergan International 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 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
March 31, 2019. Except as expressly
required by law, Allergan disclaims any intent or obligation to
update these forward-looking statements.
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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Media:
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Lisa Brown
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(862)
261-7320
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Lisa Kim
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(714)
246-3843
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