NORTH CHICAGO, Ill.,
July 25, 2021 /PRNewswire/ --
Allergan, an AbbVie (NYSE: ABBV) company, today announced new data,
including the full results from the Phase 3 GEMINI 1 clinical
study, evaluating the efficacy, safety and tolerability of
investigational AGN-190584 (pilocarpine 1.25%) ophthalmic solution
for the treatment of presbyopia.
Multiple data presentations at the 2021 ASCRS (American Society
of Cataract and Refractive Surgery) Annual Meeting demonstrated
that AGN-190584 met both its primary and key secondary efficacy
endpoints with patients achieving near and intermediate vision
gains. In addition, AGN-190584 showed no loss of distance vision, a
rapid onset of action and sustained vision gains of up to six
hours. Further details including additional efficacy and safety
results are included in the "GEMINI 1 Study Results" section
below.
GEMINI 1 data, in combination with data from the GEMINI 2 study,
formed the basis of the AGN-190584 New Drug Application (NDA)
currently under review with the U.S. Food and Drug Administration,
which the agency is expected to act on by the end of
2021.
"Building upon our heritage in eye care, we are proud to be
leading the development of a first-of-its-kind potential treatment
option for those living with presbyopia. If approved by the FDA,
AGN-190584 is expected to be the first eye drop specifically
designed for presbyopia," said Michael R.
Robinson, M.D., vice president, global therapeutic area
head, eye care, AbbVie. "We are pleased with the favorable safety
and efficacy results, as well as the rapid onset and duration of
improvement in near and intermediate vision without impacting
distance vision, from the Phase 3 GEMINI 1 clinical study."
Patient-reported outcomes presented at the meeting showed that
patients who received AGN-190584 versus the vehicle (placebo)
reported clinically meaningful and statistically significant
greater improvement in ability and satisfaction related to
near-vision reading as well as reduction in use of presbyopia
coping mechanisms during the last seven days of the trial.
"Presbyopia is a common and progressive eye condition that makes
it more difficult to focus on things up close and affects most
adults over the age of 40. While not often known by name, the 128
million Americans living with presbyopia feel the condition's
impact throughout their daily lives, often when looking at their
cell phones, reading or trying to see a menu in a dimly lit
restaurant. Additionally, our ever-increasing time spent on digital
devices, from smart watches to smart phones, has put unprecedented
demands on our vision," said George O.
Waring IV, M.D., FACS, medical director, Waring Vision
Institute, South Carolina, and
GEMINI principal study investigator. "The positive GEMINI 1
findings support the potential of AGN-190584 as a first-line option
for people living with presbyopia."
Presbyopia is caused by the loss of the eye's ability to focus
on a near object. 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 presbyopia and is instilled in both eyes, once
daily.
GEMINI 1 Study Results
The GEMINI 1 clinical study
evaluated 323 participants randomized in a one-to-one ratio of
vehicle (placebo) to AGN-190584 (pilocarpine 1.25%). AGN-190584 was
instilled bilaterally (in both eyes), once daily, for 30 days in
GEMINI 1 participants with presbyopia. The primary and key
secondary endpoints were met with a statistically significant
greater proportion of participants treated with AGN-190584 who
gained three lines or more (the ability to read three additional
lines on a reading chart) in mesopic (in low light), high contrast,
binocular Distance Corrected Near Visual Acuity (DCNVA) at Day 30,
Hour 3 (22.5%, p < 0.0001) and Hour 6 (9.7%, p = 0.0114) versus
the vehicle. The results demonstrated AGN-190584 had a rapid
onset of 15 minutes and duration of up to six hours in mesopic
DCNVA without loss of distance vision after administration at Day
30. Additional endpoints evaluated showed that 75% of participants
treated with AGN-190584 achieved a ≥2-line improvement in mesopic
DCNVA; and 93% of participants achieved ≥20/40 vision in photopic
(daylight) DCNVA. Improvements were also observed in Distance
Corrected Intermediate Visual Acuity (DCIVA) for up to 10 hours at
Day 30.
There were no treatment emergent serious adverse events observed
in any AGN-190584 treated participants. The most common treatment
emergent non-serious adverse event in AGN-190584 treated
participants occurring at a frequency of >5% was headache. Most
side effects were mild and transient in nature with only 1.2% of
patients discontinuing due to adverse events.
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 by a proprietary vehicle. The primary
mechanism of action is through pupil constriction to enhance depth
of focus and improve near and intermediate vision while maintaining
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.
*ASCRS Disclaimer: All educational content of the ASCRS ASOA
Annual Meeting is planned by its program committee, and ASCRS ASOA
does not endorse, promote, approve, or recommend the use of any
products, devices, or services.
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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