DUBLIN, May 3, 2019 /PRNewswire/ -- Allergan plc,
(NYSE: AGN), a leading global pharmaceutical company with a
heritage of more than 70 years in eye care, will present new data
for its investigational implant, Bimatoprost SR, and a
late-breaking analysis on its subconjunctival gelatin implant, XEN
Gel Stent, at the American Society of Cataract and Refractive
Surgery (ASCRS) Annual Meeting to be held in San Diego, California from May 3rd – 7th. During a
podium session on Sunday, May
5th, Allergan will present an analysis
exploring the treatment duration of Bimatoprost SR and a separate
presentation on the biodegradation data from a Phase 1/2 study.
These presentations follow data that was presented at the most
recent Association for Research in Vision and Ophthalmology (ARVO)
Annual Meeting.
"The data presented at ASCRS underscores our commitment to
turning innovative research into meaningful treatment options that
improve the experience for patients with open-angle glaucoma or
ocular hypertension," said Yehia
Hashad, M.D., Senior Vice President, Head of Global Clinical
Development, Allergan. "Building upon the intraocular pressure
lowering control of Bimatoprost SR seen in our Phase 3 trials, this
new data provides insights into how the duration of treatment and
rate of biodegradation may factor into the medicine's overall
effectiveness."
Bimatoprost SR is a first-in-class sustained-release,
biodegradable implant being evaluated for the reduction of IOP in
patients with open-angle glaucoma or ocular hypertension. Topline
Phase 3 efficacy and safety results from ongoing studies will be
presented at a congress later this year. Allergan anticipates
submitting a New Drug Application (NDA) to the FDA in the second
half of 2019.
The data analysis from a Phase 1/2, 24-month, prospective,
multicenter, dose-ranging study of 75 open-angle glaucoma patients
evaluated the rate of biodegradation on the implant and the impact
on the intraocular pressure (IOP) lowering effect of Bimatoprost
SR. A second analysis of data from the Phase 1/2 and Phase 3
clinical studies assessed the duration of IOP control based on the
time after administration of Bimatoprost SR without the use of
other IOP-lowering therapies.
Allergan will present two abstracts as podium presentations
and will have one late-breaking abstract (all noted in local
Pacific Time):
Podium Presentations:
- Duration of Effect of Intracameral Bimatoprost
Sustained-Release Implant (Bimatoprost SR) in Phase 1/2 and Phase 3
Clinical Studies
-
- Authors: Weinreb RN et al
- Date and Time: Sunday, May 5,
3:27 – 3:32 PM
- Location: SDCC – Upper Level, Room 7A
- Session Title: SPS-217 Measurements and Medications
- Biodegradation of Intracameral Bimatoprost Sustained-Release
Implant (Bimatoprost SR) in a 24-Month, Phase 1/2 Study in Glaucoma
Patients
-
- Authors: Craven ER et al
- Date and Time: Sunday, May 5,
3:32 – 3:37 PM
- Location: SDCC – Upper Level, Room 7A
- Session Title: SPS-217 Measurements and Medications
- Effectiveness and Safety of the Subconjunctival Gelatin Implant
Alone or Combined with Cataract Surgery
-
- Authors: Hengerer FH et al
- Date and Time: Sunday, May 5,
2:08 – 2:13 PM
- Location: SDCC - Upper Level, Room 7B
- Session Title: SPS-212 MIGS
Disclaimer: All educational content of the ASCRS•ASOA Annual
Meeting is planned by its program committee, and ASCRS•ASOA does
not endorse, promote, approve, or recommend the use of any
products, devices, or services.
About XEN
INDICATIONS
The XEN® Glaucoma Treatment
System (XEN® 45 Gel Stent preloaded into a
XEN® Injector) is indicated for the management of
refractory glaucomas, including cases where previous surgical
treatment has failed, cases of primary open-angle glaucoma, and
pseudoexfoliative or pigmentary glaucoma with open angles that are
unresponsive to maximum tolerated medical therapy.
IMPORTANT SAFETY
INFORMATION
CONTRAINDICATIONS
XEN® Gel
Stent is contraindicated in angle-closure glaucoma where angle has
not been surgically opened, previous glaucoma shunt/valve or
conjunctival scarring/pathologies in the target quadrant, active
inflammation, active iris neovascularization, anterior chamber
intraocular lens, intraocular silicone oil, and vitreous in the
anterior chamber.
WARNINGS
XEN® Gel Stent complications may
include choroidal effusion, hyphema, hypotony, implant migration,
implant exposure, wound leak, need for secondary surgical
intervention, and intraocular surgery complications. Safety and
effectiveness in neovascular, congenital, and infantile glaucoma
has not been established. Avoid digital pressure following
implantation of the XEN® Gel Stent to avoid the
potential for implant damage.
PRECAUTIONS
Examine the XEN® Gel Stent and
XEN® Injector in the operating room prior to use.
Monitor intraocular pressure (IOP) postoperatively and if not
adequately maintained, manage appropriately. Stop the procedure
immediately if increased resistance is observed during implantation
and use a new XEN® system. Safety and effectiveness of
more than a single implanted XEN® Gel Stent has not been
studied.
ADVERSE EVENTS
The most common postoperative adverse
events included best-corrected visual acuity loss of ≥ 2 lines (≤
30 days 15.4%; > 30 days 10.8%; 12 months 6.2%), hypotony IOP
< 6 mm Hg at any time (24.6%; no clinically significant
consequences were associated, no cases of persistent hypotony, and
no surgical intervention was required), IOP increase ≥ 10 mm Hg
from baseline (21.5%), and needling procedure (32.3%).
Caution: Federal law restricts this device to sale by or on the
order of a licensed physician. For the full Directions for Use,
please visit www.allergan.com/xen/usa.htm or call 1-800-678-1605.
Please call 1-800-433-8871 to report an adverse event.
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 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 primarily focused on four key therapeutic areas including
medical aesthetics, eye care, central nervous system and
gastroenterology.
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; 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.
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:
Amy Rose
(862) 289-3072
Lisa Kim
(714) 246-3843
View original content to download
multimedia:http://www.prnewswire.com/news-releases/allergan-to-present-two-podium-presentations-on-bimatoprost-sustained-release-sr-at-the-american-society-of-cataract-and-refractive-surgery-ascrs-annual-meeting-300843064.html
SOURCE Allergan plc