NORTH CHICAGO, Ill.,
Oct. 28, 2020 /PRNewswire/
-- Allergan, an AbbVie (NYSE: ABBV) company, today announced
the Phase 3 GEMINI 1 and 2 clinical trials evaluating the efficacy,
safety and tolerability of investigational AGN-190584 (pilocarpine
1.25%) ophthalmic solution for the treatment of symptoms associated
with presbyopia, met their primary efficacy endpoint. Additional
details of these studies will be presented at future medical
meetings and will serve as the basis for the New Drug Application
submission to U.S. Food and Drug Administration (FDA) in the first
half of 2021.
In GEMINI 1, the primary endpoint was met with a statistically
significant greater proportion of participants treated with
AGN-190584 who gained three lines (the ability to read three
additional lines on a reading chart) or more in mesopic (in low
light), high contrast, binocular Distance Corrected Near Visual
Acuity (DCNVA) at Day 30, Hour 3 versus the vehicle (placebo). In
GEMINI 2, the primary endpoint was also met with a statistically
significant greater proportion of participants treated with
AGN-190584 who gained three lines or more in mesopic, high
contrast, binocular DCNVA without loss of greater than five letters
in Corrected Distance Visual Acuity (CDVA) with the same refraction
at Day 30, Hour 3 versus the vehicle. Further details including
additional efficacy and safety results are included in the "About
the Studies" section below.
Roughly 128 million people 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.
Results from a survey of 1,339 respondents, age 40-55, found that
90% were frustrated or irritated with presbyopia.
"Presbyopia symptoms can significantly disrupt everyday
activities like reading, using a smartphone, working, and cooking,"
said George O. Waring IV, M.D.,
FACS, medical director, Waring Vision Institute, South Carolina. "While individuals currently
have several options to help manage presbyopia, including glasses,
contact lenses and surgery, research has shown that the majority of
presbyopic individuals are frustrated with the use of contact
lenses or glasses. These GEMINI findings support the possibility of
another treatment option for people living with presbyopia."
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. AGN-190584 is an investigational eye drop designed to
treat symptoms of presbyopia and is instilled in both eyes.
"Our research shows that the symptoms associated with presbyopia
can significantly impact people's daily lives," said Michael R. Robinson, M.D., vice president,
global therapeutic area head, ophthalmology, AbbVie. "The positive
results from the GEMINI studies show the potential of this
investigational optimized formulation of pilocarpine 1.25% to treat
symptoms associated with presbyopia."
About the Studies
GEMINI 1 and 2 enrolled a total of
750 patients randomized in a one-to-one ratio of vehicle (placebo)
to AGN-190584 (pilocarpine 1.25%). AGN-190584 was administered
bilaterally, once-daily, for 30 days in both GEMINI 1 and 2
participants with presbyopia. In the GEMINI studies, AGN-190584
demonstrated significant near vision gains in mesopic (in low
light) conditions without a loss of distance vision. 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 ≥3% in
AGN-190584 treated participants were headache, conjunctival
hyperaemia, vision blurred, and eye pain. In both studies, the
primary endpoint was met. The majority of secondary endpoints were
also met in both studies, including a significant improvement 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 optimized formulation of pilocarpine, a cholinergic
muscarinic receptor agonist, that is being investigated for
treating symptoms associated with presbyopia as a topical,
once-daily drop delivered by a proprietary vehicle.
The proposed mechanism of action of AGN-190584 is through
dynamic pupil modulation, an effect in which the iris sphincter is
contracted to achieve pupil size reduction in an optimal range. The
goal of this pupil size reduction is to increase depth of focus.
Secondarily, it is believed to allow for increased accommodation
through mild contraction of the ciliary muscle.
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 new 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 2019 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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