NORTH CHICAGO, Ill.,
Feb. 24, 2022 /PRNewswire/
-- Allergan, an AbbVie (NYSE: ABBV) company, today announced
new data to be presented from Allergan's leading portfolio of eye
care treatments at the 2022 American Glaucoma Society (AGS) Annual
Meeting being held in Nashville,
TN and virtually from March
3-6. Presentations will include updated analyses that help
further scientific understanding of DURYSTA®
(bimatoprost intracameral implant), as well as new data on the
XEN® Gel Stent. The DURYSTA data presentations coincide
with the two-year anniversary of the U.S. Food and Drug
Administration (FDA) approval of this first-of-its-kind eye
pressure lowering treatment for glaucoma patients in March 2020.
"Glaucoma is one of the primary causes of irreversible vision
loss and blindness worldwide. We are proud of our portfolio that
provides treatments to glaucoma patients at different stages of
their disease, but know there is still work to be done," said
Michael R. Robinson, M.D., vice
president, global therapeutic area head, eye care, AbbVie. "At AGS
2022 we will build on the growing body of knowledge around DURYSTA
two years after its FDA approval, and present additional data about
XEN investigating potential new uses of the gel stent that may
improve glaucoma patient outcomes."
Data to be presented include a new study comparing the efficacy
and safety of the XEN Gel Stent to trabeculectomy, as well as data
from the EXPAND study evaluating the real-world effectiveness and
safety of a novel investigational placement of the stent. The XEN
Gel Stent is FDA-cleared only for ab-interno placement.
Researchers will also present data from an ongoing 24-month
extension study of the Phase 3 ARTEMIS study assessing the efficacy
and duration of DURYSTA. DURYSTA was approved by the FDA in
March 2020 to reduce eye pressure, or
intraocular pressure (IOP), in patients with open angle glaucoma
(OAG) or high eye pressure (ocular hypertension, or OHT). Findings
from a study documenting DURYSTA's impact on IOP over a 24-hour
period will also be presented at the meeting.
A complete listing of the Allergan abstracts that are scheduled
to be presented at the 2022 AGS Annual Meeting can be viewed at
https://www.xcdsystem.com/ags/program/S9oEr0i/index.cfm.
Details about Allergan's presentations are as follows:
Abstract
|
Presentation
Details
All Times
CST
|
Prospective,
Randomized, Multicenter, Open-label, 12-Month Evaluation of the
Effectiveness and Safety of XEN45 vs Trabeculectomy: the Gold
Standard Pathway Study (GPS)
|
Session: Top Posters
Virtual Presentation with Q&A
Saturday, March
5
7:00 – 8:30
a.m.
|
Bimatoprost Implant
Effects on 24-Hour Intraocular Pressure
|
Session: Top
Posters Virtual Presentation with Q&A
Saturday, March
5
7:00 – 8:30
a.m.
|
Retrospective,
multicenter, real-world evaluation of ab-externo gel stent
placement: 12-month data from the EXPAND Study
|
Session: Top
Posters Virtual Presentation with Q&A
Saturday, March
5
7:00 – 8:30
a.m.
|
Extended Duration of
IOP Lowering with Bimatoprost Implant in a Phase 3 Extension
Study
|
Session: Paper
Presentations: Treatment - Live Q&A
*Note: Presentation
pre-recorded and available on demand
Saturday, March
5
9:00 – 9:40
a.m.
Summit
Ballroom
|
DURYSTA® Consumer Indications and Usage and
Important Safety Information
Approved Uses
DURYSTA® (bimatoprost
intracameral implant) is a prescription medicine to reduce eye
pressure (also called intraocular pressure, or IOP) in patients
with open angle glaucoma or high eye pressure (ocular
hypertension).
IMPORTANT SAFETY INFORMATION
DURYSTA®
should not be used if:
- You have any infection or suspected infection in your eye or
surrounding eye area
- You have corneal endothelial cell dystrophy, a condition in
which the clear front layer of your eye (cornea) has lost its
ability to work normally and can cause vision problems
- You have had a corneal transplant or cells transplanted to the
inner layer of the cornea (endothelial cell transplant)
- The sack that surrounds the lens of your eye (posterior lens
capsule) is missing or torn
- You are allergic to any of its ingredients
DURYSTA® may cause side effects involving the cornea,
including increased risk of loss of cells from the inner layer of
the cornea. You should not receive DURYSTA® more than once in each
eye. DURYSTA® should be used with caution if you have a
limited reserve of the cells lining the inner layer of the
cornea.
DURYSTA® should be used with caution if you have
narrow or obstructed iridocorneal angles (the space where the iris,
the colored part of the eye, and cornea meet).
DURYSTA® may cause swelling of the macula, the center
spot of the retina (back of the eye). DURYSTA® should be
used with caution if your eye does not have a lens, if you have an
artificial lens and a torn posterior lens capsule, or if you have
any risk factors for swelling of the macula.
DURYSTA® may cause inflammation inside the eye or
make existing inflammation worse.
DURYSTA® may cause increased brown coloring of the
iris, which may be permanent.
Eye injections have been associated with infections in the eye.
It is important that you contact your doctor right away if you
think you might be experiencing any side effects, including eye
redness, sensitivity to light, eye pain, or a change in vision,
after an injection. Your doctor should monitor you following
DURYSTA® administration.
The most common side effect involving the eyes reported in
patients using DURYSTA® was eye redness. Other common
side effects reported were: feeling like something is in your eye,
eye pain, being sensitive to light, a blood spot on the white of
your eye, dry eye, eye irritation, increased eye pressure, a loss
of cells on the inner layer of the cornea, blurry vision,
inflammation of the iris, and headache.
Please see full Prescribing Information available at
www.Durysta.com.
About XEN® Gel Stent
INDICATIONS: The XEN® Glaucoma
Treatment System is available for the surgical management of
refractory glaucomas, including cases where previous surgical
treatment did not work, cases of primary open-angle glaucoma, and
cases of pseudoexfoliative or pigmentary glaucoma with open angles
that are unresponsive to maximum tolerated medical therapy.
IMPORTANT SAFETY INFORMATION
Who should not receive
the XEN® Glaucoma Treatment
System? This surgical treatment should not be used if you
currently have any of the following: angle-closure glaucoma where
the drainage angle of the eye has not been surgically opened; a
glaucoma drainage device previously implanted or scarring and
pathologies of the conjunctiva (the clear membrane covering the
white outer layer of the eye) in the area needed for this implant;
eye inflammation (such as inflammation of the eyelids, conjunctiva,
cornea, or uvea); abnormal formation of new blood vessels on the
iris (the colored part of the eye) surface; artificial lens
implanted in the anterior chamber (the space between your cornea,
the outer transparent part of the eye, and the iris); silicone oil
in your eye; and vitreous (the transparent jelly-like tissue that
is found behind the lens) present in the anterior chamber.
What warnings should I be aware
of? XEN® Gel Stent complications may
include buildup of fluid between the choroid (inner layer of blood
vessels) and the sclera (white outer layer of the eyeball), blood
in the eye, very low eye pressure, implant moving to another part
of the eye, implant exposure, wound leak, need for additional
surgical intervention, and other eye surgery complications. The
safety and effectiveness of the XEN® Gel Stent in
neovascular, congenital, and infantile glaucoma has not been
established. After the XEN® Gel Stent procedure, to
help avoid the possibility of implant damage, avoid rubbing or
pressing your fingers on the eye in the area where the
XEN® Gel Stent was implanted.
What precautions should I be aware of? Before
surgery, your doctor will check that the device and injector are
not damaged. During surgery, your doctor will stop the procedure if
he or she observes increased resistance during implantation and
will use a new XEN® system. After surgery, your
doctor should check and manage your eye pressure appropriately. The
safety and effectiveness of implanting more than one
XEN® Gel Stent in an eye has not been studied.
What are possible side effects? The most common side
effects after surgery include reduction of vision, eye pressure
becoming too low, an increase in eye pressure, and need for an
additional surgical procedure in the eye to release scar tissue
(needling) around the implant under the conjunctiva. Talk to your
doctor about other possible side effects.
Caution: Federal law restricts this device to sale by or on the
order of a licensed physician. Click here for full Directions for
Use 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 for more than
70 years. Allergan has launched over 125 eye care
products and invested billions of dollars in treatments for the
most prevalent eye conditions including glaucoma, ocular surface
disease, and retinal diseases such as diabetic macular edema and
retinal vein occlusion.
About AbbVie
AbbVie's mission is to discover and
deliver innovative medicines that solve serious health issues today
and address the medical challenges of tomorrow. We strive to have a
remarkable impact on people's lives across several key therapeutic
areas: immunology, oncology, neuroscience, eye care, virology,
women's health and gastroenterology, in addition to products and
services across its Allergan Aesthetics portfolio. For more
information about AbbVie, please visit us at www.abbvie.com. Follow
@abbvie on Twitter, Facebook, Instagram, YouTube and
LinkedIn.
Forward-Looking Statements
Some statements in this
news release are, or may be considered, forward-looking statements
for purposes of the Private Securities Litigation Reform Act of
1995. The words "believe," "expect," "anticipate," "project" and
similar expressions, among others, generally identify
forward-looking statements. AbbVie cautions that these
forward-looking statements are subject to risks and uncertainties
that may cause actual results to differ materially from those
indicated in the forward-looking statements. Such risks and
uncertainties include, but are not limited to, failure to realize
the expected benefits of the Allergan acquisition, failure to
promptly and effectively integrate Allergan's businesses,
significant transaction costs and/or unknown or inestimable
liabilities, potential litigation associated with the Allergan
acquisition, challenges to intellectual property, competition from
other products, difficulties inherent in the research and
development process, adverse litigation or government action, and
changes to laws and regulations applicable to our industry.
Additional information about the economic, competitive,
governmental, technological and other factors that may affect
AbbVie's operations is set forth in Item 1A, "Risk Factors," of
AbbVie's 2021 Annual Report on Form 10-K, which has been filed with
the Securities and Exchange Commission (SEC). AbbVie undertakes no
obligation to release publicly any revisions to forward-looking
statements as a result of subsequent events or developments, except
as required by law.
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