NORTH CHICAGO, Ill.,
July 20, 2021 /PRNewswire/
-- Allergan, an AbbVie (NYSE: ABBV) company, today announced
that it will present new data from its leading portfolio of eye
care medicines at the 2021 ASCRS (American Society for Cataract and
Refractive Surgery) Annual Meeting being held July 23-27 in Las
Vegas, NV. Presentations will include new data on AGN-190584
(pilocarpine 1.25%), an investigational presbyopia treatment, and
updated analyses on DURYSTA™ (bimatoprost intracameral implant),
the first and only FDA-approved dissolvable implant to reduce eye
pressure in people with open angle glaucoma or high eye pressure.
"As a company, we remain committed to advancing care for
difficult-to-treat eye conditions and diseases, such as presbyopia
and glaucoma, that have a profound impact on daily life for
millions of people," said Michael R.
Robinson, M.D., vice president, global therapeutic area
head, eye care, AbbVie. "Data presented at the 2021 ASCRS Annual
Meeting will help us understand the potential for AGN-190584
to be a first-of-its-kind treatment option for those living with
presbyopia, as well as augment our knowledge of DURYSTA, which has
changed how physicians can care for patients with glaucoma."
Researchers will present new data evaluating the efficacy,
safety and tolerability of investigational AGN-190584 for the
treatment of presbyopia, inclusive of full data results from the
Phase 3 GEMINI 1 study. GEMINI 1 data, in combination with data
from the GEMINI 2 study, formed the basis of the AGN-190584 New
Drug Application (NDA) currently under review with the U.S. Food
and Drug Administration, which the agency is expected to act on by
the end of 2021.
Updated analyses from the Phase 3 ARTEMIS studies assessing the
efficacy and duration of DURYSTA will also be presented. DURYSTA
was approved by the FDA in March 2020
to reduce eye pressure (also called intraocular pressure, or IOP)
in patients with open angle glaucoma (OAG) or high eye pressure
(ocular hypertension, or OHT). Allergan has continued to collect
data to further understand how DURYSTA can best be used to benefit
patients living with glaucoma.
A complete listing of the Allergan 2021 ASCRS Annual Meeting
abstracts can be viewed at
https://ascrs.confex.com/ascrs/21am/meetingapp.cgi/Home/0.
Details about Allergan's presentations are as follows:
Abstract
Linked to ASCRS
program
|
Presentation
Details
All Times
PDT
|
Glaucoma
|
Duration of IOP
Lowering with Bimatoprost Implant and Profile of the IOP-Lowering
Response before Rescue in the Phase 3 Artemis Studies
|
Session: Minimally
Invasive Glaucoma Surgery (MIGS) III
Sunday, July
25
2:05 – 2:10
p.m.
Room: MBCR – Level 2,
Lagoon F
|
Bimatoprost Implant
for IOP Lowering: Responder Rates Overall and in Subgroups By
Previous Medication Count in the Phase 3 Artemis Studies
|
Session: Minimally
Invasive Glaucoma Surgery (MIGS) III
Sunday, July
25
2:10 – 2:15
p.m.
Room: MBCR – Level 2,
Lagoon F
|
Efficacy of
Intracameral Bimatoprost Implant in Patients Stratified By Baseline
IOP (≤25 or >25 mmHg) in the Phase 3 Artemis Studies
|
Session: Minimally
Invasive Glaucoma Surgery (MIGS) III
Sunday, July
25
2:20 – 2:25
p.m.
Room: MBCR – Level 2,
Lagoon F
|
Presbyopia
|
Gemini 1 Phase 3:
AGN-190584 Improves Intermediate Vision in Participants with
Presbyopia
|
Session: Presbyopia
Correcting IOL Comparisons, New Treatments and Studies
Sunday, July
25
8:00 – 8:05
a.m.
Room: MBCR – Level 2,
Lagoon F
|
Evaluating
Vision-Related Reading Ability with a De Novo PRO Instrument in a
Phase 3 Study of AGN-190584 (Pilocarpine 1.25%) for
Presbyopia
|
Session: Presbyopia
Correcting IOL Comparisons, New Treatments and Studies
Sunday, July
25
8:05 – 8:10
a.m.
Room: MBCR – Level 2,
Lagoon F
|
Assessing Presbyopia
Impacts and Coping Behaviors with De Novo PRO Instruments in a
Phase 3 Study of AGN-190584 (Pilocarpine 1.25%)
|
Session: Presbyopia
Correcting IOL Comparisons, New Treatments and Studies
Sunday, July
25
8:10 – 8:15
a.m.
Room: MBCR – Level 2,
Lagoon F
|
Gemini 1 Phase 3:
AGN-190584 Provides Rapid Improvement of Distance Corrected Near
Vision That Is Maintained in Participants with
Presbyopia
|
Session: Presbyopia
Correcting IOL Comparisons, New Treatments and Studies
Sunday, July
25
8:15 – 8:20
a.m.
Room: MBCR – Level 2,
Lagoon F
|
Gemini 1 Phase 3:
Safety and Efficacy of AGN-190584 in Participants with
Presbyopia
|
Session: Presbyopia
Correcting IOL Comparisons, New Treatments and Studies
Sunday, July
25
8:25 – 8:30
a.m.
Room: MBCR – Level 2,
Lagoon F
|
*ASCRS 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 AGN-190584
AGN-190584 is an investigational,
novel optimized formulation of pilocarpine specifically designed
for the treatment of presbyopia, as a topical, once-daily drop
delivered by a proprietary vehicle. The primary mechanism of action
is through dynamic pupil modulation, an effect in which the pupil
is constricted to achieve an optimal pupil size range while
maintaining pupillary response to different lighting
conditions. This allows for an increased depth of focus
without compromising distance vision.
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 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,
LinkedIn or Instagram.
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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SOURCE AbbVie