DUBLIN, Jan. 7, 2019 /PRNewswire/ -- Allergan
plc, (NYSE: AGN), a leading global pharmaceutical company, today
announced positive 3-month topline results from the second pivotal
clinical trial of Bimatoprost SR, a first-in-class
sustained-release, biodegradable implant for the reduction of IOP
in patients with open-angle glaucoma or ocular hypertension.
Positive results from the first Phase 3 trial were reported in
June 2018. Bimatoprost SR is designed
to lower IOP for at least 4 months, achieving clinical goals while
freeing patients from daily eye drop regimens. Allergan anticipates
submitting a New Drug Application (NDA) to the FDA in the second
half of 2019. Allergan is also conducting Bimatoprost SR clinical
trials for registration outside the
United States which are ongoing.
In this Phase 3 clinical study of 528 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. Results of this second Phase 3 study with an
identical design as the first study, showed that the magnitude of
IOP-lowering efficacy with Bimatoprost SR is similar to that
observed with topical prostaglandin analogues.
"The data results of intracameral Bimatoprost SR were
consistently demonstrated in two pivotal trials, highlighting the
sustained, predictable and potentially sight-saving benefits of
this exciting new approach in treating patients with glaucoma,"
said David Nicholson, Chief Research
and Development Officer, Allergan. "We are particularly encouraged
by the long-term efficacy results leading to an extended
treatment-free period."
The study also showed the potential for the vast majority of
patients to remain treatment free for at least 1 year after the
last implant was inserted. Overall, Bimatoprost SR was well
tolerated in the majority of patients. The 20-month masked study is
ongoing, and additional data will become available as patients
complete the study.
"Glaucoma is the second leading cause of blindness in the world,
making it essential to develop innovative new treatments and
technologies that effectively address the underlying cause of the
disease," said Bill Meury, Chief
Commercial Officer, Allergan. "Bimatoprost SR represents an
entirely new treatment approach for glaucoma that delivers a
trusted medication in a way that may transform treatment for
the tens of millions of people around the world with glaucoma and
ocular hypertension."
"Bimatoprost SR has the potential to be the first
sustained-release option of a drop-free therapy for patients who
are suffering from glaucoma. Proper use of eye drops continues to
be a concern for eye care professionals," 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. "With the long duration of effect observed in
this study, Bimatoprost SR can be a significant paradigm shift for
the treatment of glaucoma."
About the Bimatoprost SR 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 to
timolol eye drops used twice daily for up to 20 months. Patients
were 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) were used in the study eyes for masking
purposes. The topline results are reported at the prespecified
primary analysis time, 12 weeks after the last patient received the
first implant.
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 effective way to stop 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 compliance as a factor in
preserving vision, ophthalmologists rely on laser trabeculoplasty,
MIGS and 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 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, 2017
and Allergan's Quarterly Report on Form 10-Q for the period ended
September 30, 2018. Except as
expressly required by law, Allergan disclaims any intent or
obligation to update these forward-looking statements.
CONTACTS:
Allergan:
Investors:
Manisha Narasimhan, PhD
(862) 261-7162
Christine Chiou
862-261-7396
Media:
Amy Rose
(862) 289-3072
Fran DeSena
(862) 261-8820
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