NORTH CHICAGO, Ill.,
Feb. 25, 2021 /PRNewswire/
-- Allergan, an AbbVie (NYSE: ABBV) company, today announced
that it has submitted a New Drug Application to the U.S. Food and
Drug Administration for investigational AGN-190584 (pilocarpine
1.25%) ophthalmic solution for the treatment of presbyopia. The FDA
is expected to act on the NDA by the end of 2021.
Approximately 128 million adults in the U.S. experience
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. Yet, compared to other eye-related conditions, there
is a much lower awareness of presbyopia by name.
"Presbyopia is a significant source of frustration for most
adults over age 40 who find current treatments inconvenient or
invasive," said Tom Hudson,
MD, senior vice president, R&D, chief scientific
officer, AbbVie. "If approved, AGN-190584 is expected to be the
first eye drop to treat presbyopia, providing a novel option to
those affected in the U.S."
The NDA is based primarily on data from two Phase 3 GEMINI 1 and
GEMINI 2 clinical studies, which evaluated the efficacy, safety and
tolerability of AGN-190584 (pilocarpine 1.25%). A total of 750
patients were randomized in a one-to-one ratio of vehicle (placebo)
to AGN-190584. In both studies, AGN-190584 met the primary endpoint
reaching statistical significance in improvement in near vision in
mesopic (in low light) conditions without a loss of distance vision
vs. the vehicle. There were no treatment emergent serious adverse
events observed in any AGN-190584 treated participants. The most
common treatment emergent non-serious adverse events occurring at a
frequency of ≥5% in AGN-190584 treated participants were headache
and conjunctival hyperemia.
The Phase 3 GEMINI 1 and GEMINI 2 top-line results were
previously announced in October
2020, and additional details of these studies will be
presented at upcoming medical meetings this year.
About AGN-190584
AGN-190584 is an investigational optimized formulation of
pilocarpine, a cholinergic muscarinic receptor agonist, which
activates muscarinic receptors located at smooth muscles such as
the iris sphincter muscle and ciliary muscle and is being
investigated for the treatment of presbyopia as a topical,
once-daily drop delivered by a proprietary vehicle.
The proposed mechanism of action of AGN-190584 is through
contraction of the iris sphincter muscle, constricting the pupil to
enhance the depth of focus and improve near and intermediate visual
acuity while maintaining some pupillary response to light.
AGN-190584 also contracts the ciliary muscle, facilitating
accommodation.
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, the failure to
realize the expected benefits of AbbVie's acquisition of Allergan
or to promptly and effectively integrate Allergan's business,
challenges to intellectual property, competition from other
products, difficulties inherent in the research and development
process, adverse litigation or government action, and changes to
laws and regulations applicable to our industry. 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 2019 Annual
Report on Form 10-K, which has been filed with the Securities and
Exchange Commission, as updated by its Quarterly Reports on Form
10-Q and in other documents that AbbVie subsequently files with the
Securities and Exchange Commission that update, supplement or
supersede such information. 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