- Seven abstract presentations showcase ongoing
research in presbyopia and glaucoma
NORTH
CHICAGO, Ill., April 28,
2022 /PRNewswire/ -- Allergan, an AbbVie (NYSE: ABBV)
company, announced that it will present new data on
VUITY™ (pilocarpine HCl ophthalmic solution) 1.25%,
the first and only FDA-approved eye drop for the treatment of
presbyopia (age-related blurry near vision) in adults, and DURYSTA®
(bimatoprost intracameral implant), a first-of-its-kind
biodegradable implant to lower eye pressure for glaucoma patients,
at the 2022 Association for Research in Vision and Ophthalmology
(ARVO) Annual Meeting, May 1-4 in
Denver, CO.
"The variety of data we will present will shed light on our
continued commitment to innovate in the areas of presbyopia and
glaucoma. We are looking forward to unveiling important studies on
both VUITY and DURYSTA to show the advances we are making for those
living with these conditions," said Michael
R. Robinson, M.D., vice president, global therapeutic area
head, ophthalmology, AbbVie.
At the meeting, researchers will present new data on VUITY, a
once-daily, prescription eye drop that improves near and
intermediate vision without compromising distance vision in
patients with age-related blurry near vision. The presentation data
will include results from the GEMINI studies on pupil size, depth
of focus, and duration of efficacy among other important trial
outcomes. Presbyopia is a common and progressive eye condition that
reduces the eye's ability to focus on near objects. It usually
impacts people after age 40, affecting approximately 128 million
Americans or nearly half of the U.S. adult population.
In addition, attendees will learn of new research findings on
DURYSTA. The presentation will focus on the duration of intraocular
pressure (IOP) control following DURYSTA
administration.
A complete listing of the Allergan ARVO 2022 Annual Meeting
abstracts can be viewed at:
https://arvo2022.arvo.org/abstracts.
Details about Allergan's presentations are as follows:
Abstract
Linked to ARVO
program
|
Presentation
Details
All Times
EDT
|
Presbyopia
|
Plasma pharmacokinetics
of pilocarpine in participants administered VUITY (pilocarpine HCl
ophthalmic solution) 1.25%
|
Session: IOLs and
Presbyopia
Monday, May 2,
2022
2:30 PM to 4:30
PM
Posterboard Number:
1808 – F0424
|
Optimal pupil size for
near-vision improvement without distance-vision loss in the GEMINI
studies of AGN-190584 in presbyopia
|
Session: IOLs and
Presbyopia
Monday, May 2,
2022
2:30 PM to 4:30
PM
Posterboard Number:
1810 – F0426
|
Corneal Permeability of
Pilocarpine HCl 1.25% with Varying pH Formulations
|
Session: IOLs and
Presbyopia
Monday, May 2,
2022
2:30 PM to 4:30
PM
Posterboard Number:
1814 – F0430
|
Extended Depth of Focus
from AGN-190584 in GEMINI 1 and GEMINI 2 Pooled Phase 3
Studies
|
Session: IOLs and
Presbyopia
Monday, May 2,
2022
2:30 PM to 4:30
PM
Posterboard Number:
1812 – F0428
|
No Impact of Headache
or Visual Impairment Adverse Events following AGN-190584 Observed
on Patient Reported Outcomes
|
Session: IOLs and
Presbyopia
Monday, May 2,
2022
2:30 PM to 4:30
PM
Posterboard Number:
1815 – F0431
|
Duration of Efficacy of
AGN-190584 on Photopic Distance-Corrected Intermediate Visual
Acuity in the GEMINI 1 and GEMINI 2 Pooled Phase 3
Studies
|
Session: IOLs and
Presbyopia
Monday, May 2,
2022
2:30 PM to 4:30
PM
Posterboard Number:
1811 – F0427
|
Glaucoma
|
Longevity of IOP
Control Post Single Bimatoprost Implant Injection in a Phase 3b
Study
|
Session: Clinical
Studies and Trials
Wednesday, May 4, 2022
12:34 PM to 12:51
PM
Room 601/603 Denver
Convention Center
|
About VUITY
VUITY is an optimized formulation of
pilocarpine, an established eye care therapeutic, specifically
designed to treat age-related blurry near vision. It is delivered
with proprietary pHast™ technology, which allows VUITY to rapidly
adjust to the physiologic pH of the tear film. This was studied in
simulated tear film, and the clinical significance is unknown.
VUITY uses the eye's own ability to reduce pupil size and improves
near and intermediate vision without compromising distance
vision.
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 at www.VUITY.com or call
1-833-MY-VUITY.
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® 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.
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.
If you are having difficulty paying for your medicine, AbbVie
may be able to help. Visit AbbVie.com/myAbbVieAssist to learn
more.
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 our 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 2021 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