NORTH CHICAGO, Ill.,
Oct. 26, 2021 /PRNewswire/
-- Allergan, an AbbVie (NYSE: ABBV) company, today
announced that it will present new pooled analyses and post hoc
results from the Phase 3 trials of AGN-190584 (pilocarpine HCl
ophthalmic solution 1.25%), an investigational novel treatment for
presbyopia, at Academy 2021, the annual meeting of the American
Academy of Optometry, November 3-6.
Presentations will include clinical results for near and
intermediate vision, functional near vision, efficacy for
post-LASIK patients, and the patient experience.
"We look forward to sharing data from AGN-190584's Phase 3 study
results with attendees at Academy 2021 that not only show an
improvement in near vision in presbyopia patients, but also shed
light on how practitioners may implement this treatment in the real
world, pending approval," said Michael R. Robinson, M.D., vice president, global
therapeutic area head, eye care, AbbVie. "Optometrists well
understand the daily challenges of those living with age-related
blurry near vision called presbyopia, a progressive vision
condition that affects nearly all of us as we age. Building
upon our heritage of innovation in eye care, we look forward to the
potential of bringing forth a completely new treatment option for
eye care professionals to offer their patients."
Investigational AGN-190584 was specifically designed for the
treatment of presbyopia. An optimized formulation of pilocarpine
1.25% with pHast™ technology was selected after the development of
this proprietary vehicle and rigorous testing of 16 formulations. A
New Drug Application was submitted to the U.S. Food and Drug
Administration earlier this year and full Phase 3 GEMINI 1 study
results were announced in July. Allergan, an AbbVie company,
intends to market the treatment as VUITY™ (pilocarpine HCl
ophthalmic solution 1.25%) pending FDA approval.
Abstracts for Academy 2021 can be viewed on the Academy website
HERE.
Posters are listed below and will be displayed all day
November 4, 2021. Authors will be
present from 4:30 pm to 6:30 pm ET
for questions.
- AGN-190584 Improves Intermediate Vision in Pooled Phase 3
Studies GEMINI 1 and 2;
- Comparison of Participants with and without LASIK in Near
Vision Improvement with AGN-190584 Treatment;
- Near Vision Line Improvement Stratified by Baseline Severity
with AGN-190584 in Pooled Phase 3 Studies GEMINI 1 and 2;
- Pooled Phase 3 GEMINI 1 and 2: AGN-190584 Improves Functional
Near Vision;
- Interpreting Clinically Meaningful Near Vision Improvement in
Presbyopia with AGN-190584 in the Gemini 1 Phase 3 Trial;
- GEMINI 1 and 2 Patient Experience with the Use of AGN-190584
(Pilocarpine 1.25%) for Presbyopia
About the Phase 3 Studies
GEMINI 1 and GEMINI 2
enrolled a total of 750 patients randomized in a one-to-one ratio
of vehicle (placebo) to AGN-190584 (pilocarpine HCl ophthalmic
solution 1.25%). Both studies met the primary endpoint, achieving
statistical significance compared to vehicle in improvement in
mesopic (low light) near vision on Day 30, Hour 3 without
compromising distance vision. AGN-190584 was administered in each
eye once-daily, for 30 days in both GEMINI 1 and GEMINI 2
participants with presbyopia. There were no treatment emergent
serious adverse events observed in any AGN-190584 treated
participants. The most common adverse reactions reported in >5%
of patients were headache and conjunctival hyperemia. The majority
of secondary endpoints were also met in both studies, including a
significant improvement vs. vehicle in patient-reported outcomes
(PROs) such as an increase in vision-related reading ability, and
reductions in the impact of presbyopia on daily life and use of
coping behaviors to manage presbyopia.
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 with pHast™ technology, a
proprietary vehicle. This allows AGN-190584 to rapidly adjust to
the physiologic pH of the tear film. The primary mechanism of
action is through pupil constriction to improve near and
intermediate vision while maintaining some pupillary response to
different lighting conditions – an effect known as dynamic pupil
modulation.
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