NORTH CHICAGO, Ill.,
Nov. 8, 2021 /PRNewswire/
-- Allergan, an AbbVie (NYSE: ABBV) company, announced that it
will present new pooled post-hoc analyses and patient-reported
outcomes (PROs) of VUITYTM (pilocarpine HCl
ophthalmic solution) 1.25%, newly approved by the FDA as the first
and only eye drop to treat presbyopia; additional analyses on
DURYSTA® (bimatoprost intracameral implant); and three
real-world data studies on the glaucoma patient journey at the AAO
(American Academy of Ophthalmology) 2021 Annual Meeting,
November 12-15.
"The importance of improving visual function cannot be
overstated, especially in the context of conditions such as
presbyopia, which can have a significant effect on daily
activities," said Michael R.
Robinson, M.D., vice president, global therapeutic area
head, eye care, AbbVie. "The research we will present at the AAO
2021 Annual Meeting reflects our ongoing commitment to innovation
that can change how patients manage their conditions."
Roughly 128 million people, nearly half of the U.S. adult
population, experience age-related blurry near vision or
presbyopia, a common and progressive eye condition that reduces the
eye's ability to focus on near objects and usually impacts people
after age 40.
VUITY is the first and only FDA-approved eye drop to treat
presbyopia, commonly known as age-related blurry near vision, in
adults. VUITY is a daily, prescription eye drop
that improves near and intermediate vision without impacting
distance vision. Specifically designed for presbyopia, VUITY is
an optimized formulation of pilocarpine, an established eye
care therapeutic, delivered with pHast™ technology. The proprietary
pHast™ technology allows VUITY to rapidly adjust to the
physiologic pH of the tear film. VUITY uses the eye's own ability
to reduce pupil size, improving near vision without affecting
distance vision.
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
(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 further research DURYSTA to
identify best use and practices in the clinical setting.
A complete listing of the Allergan AAO 2021 Annual Meeting
abstracts can be viewed at
https://registration.experientevent.com/showaao211/flow/Attendee#!/registrant//ShowItems/.
Details about Allergan's presentations are as follows:
Abstract
|
Presentation
Details
All Times
CST
|
Presbyopia
|
PA031 - GEMINI 1 and
GEMINI 2 Pooled Phase 3 Safety and Efficacy: AGN-190584 Primary and
Key Secondary Endpoints
|
Session: OP06 -
Refractive Original Papers
Sunday,
November 14
9:45 – 9:52
a.m.
Room:
255-257
|
PO016 -
Patient-Reported Outcomes in Pooled Phase 3 Studies of AGN-190584
(Pilocarpine 1.25%) for Presbyopia
|
Session: PT04 -
Poster Theater: Refractive Surgery
Saturday, November
13
2:26 – 2:37
p.m.
Room: Hall
C
|
Glaucoma
|
PO062 Real-World
Survival of Medical Treatment Stability in OAG: A Multicenter,
Retrospective Cohort Study
|
Session: PT13 -
Poster Theater: Glaucoma
Monday, November
15
1:29 – 1:40
p.m.
Room: Hall
C
|
PO080 Extended
Duration of IOP Lowering With Bimatoprost Implant in a Phase 3
Clinical Trial
|
Session: PD05 -
Glaucoma Poster Discussion
On Demand
Only
|
PA038 - Health-Care
Burden Following Laser Trabeculoplasty and iStent in U.S. Clinical
Practice: Medication Use and Subsequent Procedures
|
Session: OP07 -
Glaucoma Original Papers
Sunday, November
14
11:42 – 11:49
a.m.
Room:
255-257
|
PO010 Health-Care
Resource Utilization After Incisional Glaucoma Surgery in U.S.
Clinical Practice
|
Session: PT02 -
Poster Theater: Glaucoma
Saturday, November
13
11:29 – 11:40
a.m.
Room: Hall
C
|
About Presbyopia
Presbyopia is caused by the loss of
the eye's ability as it ages to focus on a near object. In a
non-presbyopic eye, the clear lens behind the iris can change shape
and focus light to the retina, making it easier to see things up
close. In a presbyopic eye, the clear lens hardens and does not
change shape as easily, making it difficult to focus on near
objects.
VUITY Use and Important Safety Information
USE
VUITY™ (pilocarpine hydrochloride ophthalmic
solution) 1.25% is a prescription eye drop used to treat
age-related blurry near vision (presbyopia) in adults.
IMPORTANT SAFETY INFORMATION
- Do not use VUITY if you are allergic to any of the
ingredients.
- Use caution when driving at night or performing hazardous
activities in poor lighting.
- Temporary problems when changing focus between near and distant
objects may occur. Do not drive or use machinery if vision is not
clear.
- Seek immediate medical care if you experience any sudden vision
loss.
- If you wear contact lenses, they should be removed prior to
VUITY use. Wait 10 minutes after dosing before reinserting contact
lenses.
- Do not touch the dropper tip to any surface as this may
contaminate the contents.
- If more than one topical eye medication is being used, the
medicines must be administered at least 5 minutes apart.
- The most common side effects are headache and eye redness.
These are not all the possible side effects of VUITY.
Please see full Prescribing
Information.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit
www.fda.gov/medwatch or call 1-800-FDA-1088.
DURYSTA® 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, 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.
View original
content:https://www.prnewswire.com/news-releases/allergan-an-abbvie-company-to-present-new-data-from-its-leading-eye-care-portfolio-at-the-aao-american-academy-of-ophthalmology-2021-annual-meeting-301418026.html
SOURCE AbbVie