- Seven abstract presentations reinforce leadership in eye
care, including continued presbyopia and glaucoma treatment
research
NORTH
CHICAGO, Ill., April 19,
2022 /PRNewswire/ -- Allergan, an AbbVie (NYSE:
ABBV) company, announced that it will present new data from its
leading eye care portfolio at the 2022 American Society for
Cataract and Refractive Surgery (ASCRS) Annual Meeting being held
April 22 – 26 in Washington, D.C. Presentations will include
new data on VUITYTM (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 XEN® Gel Stent, a surgical implant designed to
lower high eye pressure, FDA-cleared for refractory glaucoma
patients.
"The data we'll be presenting at ASCRS showcases our continued
commitment to innovate and provide additional treatment options for
patients with eye conditions like presbyopia and glaucoma," said
Michael R. Robinson, M.D., vice
president, global therapeutic area head, ophthalmology, AbbVie.
At the meeting, researchers will present new studies on the
safety and efficacy of VUITY in a variety of settings. Notable data
will include a post-hoc analysis evaluating the use of VUITY in
participants with moderate to advanced presbyopia and a new
analysis evaluating the onset of efficacy in participants with
presbyopia. AbbVie will also present an analysis evaluating
intermediate vision for presbyopia patients treated with VUITY.
Additionally, new analyses from studies assessing the safety and
efficacy of the XEN® Gel Stent will be presented. The
XEN® Glaucoma Treatment System is indicated for the
surgical management of refractory glaucoma, 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.
The XEN® Gel Stent is FDA-cleared for insertion via an
ab interno approach; ab externo insertion of
XEN® Gel Stent is investigational and the safety and
efficacy of this approach have not been evaluated by the FDA.
A complete listing of the Allergan ASCRS 2022 Annual Meeting
abstracts can be viewed at
https://ascrs.confex.com/ascrs/22am/meetingapp.cgi/Home/0.
Details about Allergan's presentations are as follows:
Abstract
Linked to ASCRS
program
|
Presentation
Details
All Times ET
|
Presbyopia
|
GEMINI 1 & 2 Pooled
Phase 3: The Proportion of
Subjects with Clinically Meaningful Near Vision
Improvement
|
Session: Presbyopia
Correction – Outcomes/Comparisons
Saturday, April 23,
2022
10:15 – 10:20
AM
Room: WEWCC - Level 1,
143B
|
AGN-190584 and Rapid
Visual Acuity Improvement
in Presbyopia on Day 1 of Treatment: Results from
the Phase 3 Studies
|
Session: Presbyopia
Correction – Outcomes/Comparisons
Saturday, April 23,
2022
10:28 – 10:33
AM
Room: WEWCC - Level 1,
143B
|
GEMINI 1 & 2 Pooled
Phase 3: The Evaluation of
Intermediate Vision for Presbyopia Patients Treated
with AGN-190584
|
Session: Presbyopia
Correction – Outcomes/Comparisons
Saturday, April 23,
2022
10:23 – 10:28
AM
Room: WEWCC – Level 1,
143B
|
AGN-190584 Improves
Photopic Distance
Corrected Near Vision in Participants with Mild to
Moderate Presbyopia: Results of the Phase 3
Studies
|
Session: Presbyopia
Correction – Outcomes/Comparisons
Saturday, April 23,
2022
10:33 – 10:38
AM
Room: WEWCC - Level 1,
143B
|
AGN-190584 Improves
Near and Intermediate
Vision in a Subgroup of Subjects with Moderate to
Advanced Presbyopia
|
Session: Presbyopia
Correction: New Treatments and Studies
Monday, April 25,
2022
4:10 – 4:15
PM
Room: WEWCC - Level 1,
143C
|
Glaucoma
|
Randomized,
Multicenter, 12-Month Evaluation of
Effectiveness and Safety of the Gel Stent Vs
Trabeculectomy: The Gold Standard Pathway Study
|
Session: Glaucoma –
Procedures
Sunday, April 24,
2022
3:30 – 3:35
PM
Room: WEWCC – Level 1,
143C
|
12-Month Outcomes Of
Ab-Externo Gel Stent
Placement In Eyes Naïve Vs Not Naïve To
Conjunctival-Incisional Glaucoma Surgery:
The EXPAND Study
|
Session: Glaucoma –
Procedures
Sunday, April 24,
2022
3:58 – 4:03
PM
Room: WEWCC – Level 1,
143C
|
*ASCRS Disclaimer: All educational content of the ASCRS Annual
Meeting is planned by its program committee, and ASCRS does not
endorse, promote, approve, or recommend the use of any products,
devices, or services.
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.
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 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