DUBLIN, March 5, 2020 /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 approved
the company's New Drug Application (NDA) for DURYSTA™ (bimatoprost
implant) 10 mcg for intracameral administration. With this
approval, DURYSTA™ becomes the first intracameral, biodegradable
sustained-release implant indicated to reduce intraocular pressure
(IOP) in patients with open-angle glaucoma (OAG) or ocular
hypertension (OHT).
"Today's FDA approval marks a breakthrough milestone for the
glaucoma community and provides a much-needed option for patients
challenged with topical drops or needing alternative
options," said David Nicholson, Chief Research and
Development Officer, Allergan. "At Allergan, our mission is to
contribute meaningful strategies that help preserve people's
vision, while ensuring that therapies are mindful of the realities
of administration and compliance. As a commitment to the ongoing
development of this innovation, Allergan has five ongoing Phase 3
studies with DURYSTA™ to support further potential FDA
label enhancement and rest of the world approvals."
The FDA approval is based on results from the two 20-month
(including 8-month extended follow up) Phase 3 ARTEMIS studies
evaluating 1,122 subjects on the efficacy and safety of
DURYSTA™ versus twice daily topical timolol drops, an FDA
accepted comparator for registrational clinical trials, in patients
with OAG or OHT. In the two Phase 3 ARTEMIS studies,
DURYSTA™ reduced IOP by approximately 30 percent from
baseline over the 12-week primary efficacy period, meeting the
predefined criteria for non-inferiority to the study
comparator.
"Millions of people are living with glaucoma, one of the leading
causes of vision loss; however, new treatment options are needed to
help doctors and patients better manage this disease," said
Felipe Medeiros, M.D., Ph.D.,
Distinguished Professor of Ophthalmology and Vice-Chair for
Technology, Director Clinical Research Unit, Department of
Ophthalmology, Duke University. "The
ARTEMIS trials demonstrated that DURYSTA™ lowered IOP
in patients by approximately 30 percent and demonstrated a duration
of effect through the 12-week primary efficacy period. As the first
FDA-approved intracameral, biodegradable sustained-release implant
providing continuous drug delivery, DURYSTA™ has the potential to
significantly shift the paradigm for treating glaucoma."
With the launch of DURYSTA™, Allergan proudly expands
availability of Allergan EyeCue®, a proven reimbursement
service for eye care professionals to facilitate patient benefit
verification, savings program enrollment for eligible patients, and
prior authorization (PA) assistance for Allergan Eye Care
products.
About DURYSTA™
DURYSTA™ is a prostaglandin analog
indicated for the reduction of IOP in patients with OAG or OHT.
DURYSTA™ is an ophthalmic drug delivery system for a
single intracameral administration of a biodegradable implant
containing 10 mcg bimatoprost. DURYSTA™ should not be
re-administered to an eye that received a prior DURYSTA™.
DURYSTA™ is preloaded into a single-use applicator to
facilitate the administration of the biodegradable implant directly
into the anterior chamber of the eye.
INDICATIONS AND USAGE
DURYSTA™ (bimatoprost implant)
is indicated for the reduction of intraocular pressure (IOP) in
patients with open angle glaucoma (OAG) or ocular hypertension
(OHT).
IMPORTANT SAFETY
INFORMATION
CONTRAINDICATIONS
DURYSTA™ is
contraindicated in patients with: active or suspected ocular or
periocular infections; corneal endothelial cell dystrophy (e.g.,
Fuchs' Dystrophy); prior corneal transplantation or endothelial
cell transplants (e.g., Descemet's Stripping Automated Endothelial
Keratoplasty [DSAEK]); absent or ruptured posterior lens capsule,
due to the risk of implant migration into the posterior segment;
hypersensitivity to bimatoprost or to any other components of the
product.
WARNINGS AND PRECAUTIONS
The presence of DURYSTA™
implants has been associated with corneal adverse reactions and
increased risk of corneal endothelial cell loss. Administration of
DURYSTA™ should be limited to a single implant per eye without
retreatment. Caution should be used when prescribing DURYSTA™ in
patients with limited corneal endothelial cell reserve.
DURYSTA™ should be used with caution in patients with narrow
iridocorneal angles (Shaffer grade ˂ 3) or anatomical obstruction
(e.g., scarring) that may prohibit settling in the inferior
angle.
Macular edema, including cystoid macular edema, has been
reported during treatment with ophthalmic bimatoprost, including
DURYSTA™ intracameral implant. DURYSTA™ should be used with caution
in aphakic patients, in pseudophakic patients with a torn posterior
lens capsule, or in patients with known risk factors for macular
edema.
Prostaglandin analogs, including DURYSTA™, have been reported to
cause intraocular inflammation. DURYSTA™ should be used with
caution in patients with active intraocular inflammation (e.g.,
uveitis) because the inflammation may be exacerbated.
Ophthalmic bimatoprost, including DURYSTA™ intracameral implant,
has been reported to cause changes to pigmented tissues, such as
increased pigmentation of the iris. Pigmentation of the iris is
likely to be permanent. Patients who receive treatment should be
informed of the possibility of increased pigmentation. While
treatment with DURYSTA™ can be continued in patients who develop
noticeably increased iris pigmentation, these patients should be
examined regularly.
Intraocular surgical procedures and injections have been
associated with endophthalmitis. Proper aseptic technique must
always be used with administering DURYSTA™, and patients should be
monitored following the administration.
ADVERSE REACTIONS
In controlled studies, the most
common ocular adverse reaction reported by 27% of patients was
conjunctival hyperemia. Other common adverse reactions reported in
5%‑10% of patients were foreign body sensation, eye pain,
photophobia, conjunctival hemorrhage, dry eye, eye irritation,
intraocular pressure increased, corneal endothelial cell loss,
vision blurred, iritis, and headache.
Please see link to full prescribing information
For more information about DURYSTA, visit
www.DURYSTAhcp.com
About Glaucoma
Glaucoma is one of the primary
causes of irreversible vision loss and blindness. An estimated 70
million people globally are living with glaucoma. 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 of
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 a standard
first-line treatment for open-angle glaucoma, the most common form,
but low patient adherence to these medications is common – up to 80
percent of patients are not using topical medications as
prescribed. Poor adherence to glaucoma medication could result in
disease progression and vision loss.
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 for more than 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, 2019.
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
Media:
Lisa Brown
(862) 261-7320
Lisa Kim
(714) 246-3843
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