Acucela Inc. (TOKYO:4589), a clinical-stage biotechnology company that
specializes in discovering and developing novel therapeutics to treat
and slow the progression of sight-threatening ophthalmic diseases, today
announced that it has completed enrollment in its ongoing Phase 2b/3
clinical trial investigating emixustat in subjects with geographic
atrophy (GA) associated with dry age-related macular degeneration (AMD).
The Safety and Efficacy Assessment Treatment Trials of Emixustat
hydrochloride (SEATTLE) study is a multicenter, randomized,
double-masked, dose-ranging trial initiated in early 2013
(ClinicalTrials.gov identifier: NCT01802866). 508 patients with GA
associated with dry AMD were enrolled in the clinical trial. Emixustat
is being studied to determine whether it slows the rate of progression
of GA lesions in these patients.
"Completing enrollment in this trial ahead of schedule represents a
tremendous achievement for the program," stated Ryo Kubota, MD, PhD,
Chairman, President and CEO, Acucela Inc.
Emixustat, the first internally developed compound by Acucela, is orally
dosed, targets the visual cycle, and is in development for the treatment
of GA associated with dry AMD. There is currently no therapy approved by
the Food and Drug Administration to treat dry AMD.
About Dry Age-related Macular Degeneration (dry AMD)
Age-related macular degeneration is associated with irreversible vision
loss in severe cases. More than 10 million people in the United States
and more than 120 million people worldwide are affected by AMD.1
Geographic atrophy is an advanced stage of dry AMD which can cause legal
About Acucela Inc.
Acucela Inc. (www.acucela.com
is a clinical-stage biotechnology company that specializes in
discovering and developing novel therapeutics to treat and slow the
progression of sight-threatening ophthalmic diseases impacting millions
of individuals worldwide. Acucela currently has the following candidates
in development with Otsuka Pharmaceutical Co, Ltd.: emixustat
hydrochloride for GA associated with dry AMD based on Acucela's
proprietary visual cycle modulation; and OPA-6566 for ocular
hypertension and glaucoma.
Statements contained in this press release are forward-looking
statements made pursuant to the safe harbor provisions of the Private
Securities Litigation Reform Act of 1995. Any statements contained in
this press release that are not statements of historical fact may be
deemed to be forward-looking statements. Words such as "believes,"
"anticipates," "plans," "expects," "will," "intends," "potential,"
"possible" and similar expressions are intended to identify
forward-looking statements. These forward-looking statements include
Acucela's expectations regarding clinical development activities. These
statements involve risks and uncertainties that could cause the
Company's actual results to differ materially from those projected in
forward-looking statements, including, but not limited to the risk that
our product candidates will not demonstrate the expected benefits and
will not achieve regulatory approval or be successfully commercialized,
the success of our product candidates depends heavily on the willingness
of our collaboration partner to continue to co-develop our product
candidates, the risk of delays in our expected clinical trials, the risk
that new developments in the intensely competitive ophthalmic
pharmaceutical market require changes in our clinical trial plans or
limit the potential benefits of our product candidates, our dependence
on and our ability to retain and motivate our key management and
scientific staff, including Ryo Kubota, M.D., Ph.D., and other risks and
uncertainties inherent in the process of discovering and developing
therapeutics that demonstrate safety and efficacy. For a detailed
discussion of these and other risk factors, please refer to the
Company's filings with the Securities and Exchange Commission, including
the final prospectus related to its initial public offering, which are
available on the Company's investor relations Web site (http://ir.acucela.com/)
and on the SEC's Web site (http://www.sec.gov).
(1) 2012 Comprehensive Report on The Global Retinal Pharmaceuticals &
Biologics Market, Market Scope.
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