NORTH CHICAGO, Ill.,
April 27, 2021 /PRNewswire/
-- Allergan, an AbbVie (NYSE: ABBV) company, today announced
that it will present new data, including real-world evidence, and
patient-reported outcomes (PROs) for products across its eye care
portfolio and pipeline at the ARVO (Association for Research in
Vision and Ophthalmology) 2021 Annual Virtual Meeting (May 1-7).
"We are excited to present a range of data that will help us
better understand not just how our portfolio performs in the
clinic, but also the real-world experiences of our patients," said
Michael R. Robinson, M.D., vice
president, global therapeutic area head, eye care, AbbVie. "The
diversity of our data at ARVO 2021 demonstrates how Allergan Eye
Care is advancing potential treatments for patients living with a
number of difficult-to-treat eye diseases including presbyopia and
retina diseases such as age-related macular degeneration."
The company will present patient-reported outcomes for
AGN-190584, an investigational therapy for the treatment of
presbyopia. Recently the company submitted a New Drug
Application (NDA) to the U.S. Food and Drug Administration based on
data from the Phase 3 GEMINI 1 and GEMINI 2 clinical studies.
Data presented at the meeting will also include new analyses
from the Phase 3 ARTEMIS studies examining the duration of
intraocular pressure (IOP) lowering and biodegradation kinetics of
DURYSTA™.
Additionally, real world data from the multicenter EXPAND study,
evaluating 12-month outcomes of an investigation into a novel
placement of the XEN® Gel Stent, will be presented at the meeting.
The XEN® Gel Stent is currently approved only for ab-interno
placement.
The ARVO 2021 Annual Virtual Meeting abstracts can be viewed at
https://arvo2021.arvo.org/agenda.
Details about the presentations are as follows:
Abstract
|
Presentation
Details
All Times
EDT
|
Glaucoma
|
Extended Duration of
IOP Lowering with Bimatoprost Implant in
a Phase 3 Open-label Extension Study
|
Paper session:
Pharmacological intervention or
cellular mechanisms
Sunday, May
2
11:15 a.m.
EDT
|
A Minipump Continuous
Drug Infusion Dog Model System to
Identify Candidate Drugs and Drug Delivery Rates for
Intracameral IOP-lowering Implants
|
Poster session:
Pharmacological intervention
and cellular mechanisms
Monday, May
3
11:15 a.m.
EDT
|
Rate of Bimatoprost
Implant Biodegradation in the Phase 3
ARTEMIS Studies
|
Paper session:
Clinical Studies
Monday, May
3
11:15 a.m.
EDT
|
Corneal Endothelial
Cell Loss Associated with Selective Laser
Trabeculoplasty
|
Poster session:
Ocular Blood Flow, Laser
Therapy, and IOP Measurements
Wednesday, May
5
2:45 p.m.
EDT
|
A Retrospective
Analysis: Visual Field Progression and Visual
Acuity following Administration of Brimonidine Drug Delivery
System
|
Poster session:
Structure/Function, Visual
Fields, Psychophysics, and Electrophysiology
Monday, May
3
4:30 p.m.
EDT
|
Retrospective,
Multicenter, 12-month Evaluation of Ab-externo
XEN Gel Stent Placement: Real-world Data from the EXPAND
Study Group
|
Poster session:
Surgery and Wound Healing I
and II
Wednesday, May
5
9:00 a.m.
EDT
|
Presbyopia
|
Evaluating
Vision-related Reading Ability With a de Novo PRO
Instrument in a Phase 3 Study of AGN-190584 (Pilocarpine
1.25%) for Presbyopia
|
Poster session:
Refractive error, refraction,
accommodation and presbyopia
Thursday, May
6
11:15 a.m.
EDT
|
Assessing Presbyopia
Impacts and Coping Behaviors with a de
Novo PRO Instrument
in a Phase 3 Study of AGN-190584
(Pilocarpine 1.25%)
|
Poster session:
Refractive error, refraction,
accommodation and presbyopia
Thursday, May
6
11:15 a.m.
EDT
|
Age-related
Macular Degeneration
|
Duration of Effect of
a Single Intravitreal Injection of a
Sustained-release Formulation of Abicipar Pegol Compared to
a Bolus Dose of Aflibercept in a Rabbit Model of Persistent
Retinal Vascular Leak
|
Poster session: AMD
and retinal physiology
Wednesday, May
5
2:45 p.m.
EDT
|
Developing
Methotrexate-induced Immune Tolerance in a
Rabbit Model of Persistent Retinal Vascular Leak
|
Poster session: AMD
and retinal physiology
Wednesday, May
5
2:45 p.m.
EDT
|
Comparison of Visual
Function in a Non-human Primate (NHP)
Model of Retinal Injury to Human Age-related Macular
Degeneration (AMD) Patients
|
Poster session:
Psychophysics
Friday, May
7
2:15 p.m.
EDT
|
Cytoprotective
Effects of Brimonidine in an Induced Pluripotent
Stem Cell (iPSC)-derived Retinal Pigment Epithelium (RPE)
Model of Age-related Macular Degeneration (AMD)
|
Poster session: AMD
and retinal physiology
Wednesday, May
5
2:45 p.m.
EDT
|
Diabetic Macular
Edema
|
Profile of Vascular
Permeability Factors in Aqueous Humor of
Diabetic Macular Edema
|
Poster session:
Diabetic macular edema
Friday, May
7
2:15 p.m.
EDT
|
About AGN-190584
AGN-190584 is an investigational optimized formulation of
pilocarpine, a cholinergic muscarinic receptor agonist, which
activates muscarinic receptors located at smooth muscles such as
the iris sphincter muscle and ciliary muscle and is being
investigated for the treatment of presbyopia as a topical,
once-daily drop delivered by a proprietary vehicle.
The proposed mechanism of action of AGN-190584 is through
contraction of the iris sphincter muscle, constricting the pupil to
enhance the depth of focus and improve near and intermediate visual
acuity while maintaining some pupillary response to light.
AGN-190584 also contracts the ciliary muscle, facilitating
accommodation.
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
intracameral 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
http://www.DURYSTAhcp.com
About XEN® Gel Stent
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%).
Click here for the full Directions for Use.
For more information about XEN, visit
https://hcp.xengelstent.com/
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 from AbbVie's acquisition of Allergan plc
("Allergan"), failure to promptly and effectively integrate
Allergan's businesses, competition from other products, challenges
to intellectual property, difficulties inherent in the research and
development process, adverse litigation or government action,
changes to laws and regulations applicable to our industry and the
impact of public health outbreaks, epidemics or pandemics, such as
COVID-19. 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 2020 Annual Report on Form 10-K, which has been filed with
the Securities and Exchange Commission, as updated by its
subsequent Quarterly Reports on Form 10-Q. 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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