|[August 27, 2013]
Acucela Reaches 50% Enrollment in the Emixustat Hydrochloride Phase 2b/3 Clinical Trial
SEATTLE --(Business Wire)--
Acucela Inc., a clinical-stage biotechnology company focused on
developing new treatments for sight-threatening eye diseases, today
announced that it has achieved 50% subject enrollment in its ongoing
Phase 2b/3 clinical trial investigating emixustat hydrochloride in
patients with geographic atrophy (GA) associated with dry age-related
macular degeneration (AMD (News - Alert)). The Safety and Efficacy Assessment Treatment
Trials of Emixustat Hydrochloride (the SEATTLE) study is a multicenter,
randomized, double-masked, dose-ranging study initiated earlier this
year (ClinicalTrials.gov identifier: NCT01802866). A total of
approximately 440 patients with GA associated with dry AMD are expected
to be enrolled in the study across 56 sites, primarily in the United
States. Emixustat hydrochloride is being studied to determine whether it
slows the progression of GA lesions in these patients.
AMD is the most common cause of irreversible vision loss in the
developed world, the overwhelming majority of which is associated with
dry AMD. There are currently no medications approved to treat GA
associated with dry AMD.
"We are thrilled to have achieved 50% enrollment in the emixustat
hydrochloride Phase 2b/3 trial ahead of schedule," stated Ryo Kubota,
MD, PhD, Chairman, President and CEO, Acucela Inc. "Today's announcement
is great news fr Acucela and for the emixustat hydrochloride program."
Emixustat hydrochloride, the first internally developed compound by
Acucela, is orally dosed, targets the visual cycle, and may represent a
potentially novel therapeutic approach for the treatment of retinal
diseases, such as GA associated with dry AMD.
About Dry Age-related Macular Degeneration (AMD)
More than 10 million people in the US and more than 120 million people
worldwide have age-related macular degeneration.1 AMD is
associated with irreversible vision loss, the overwhelming majority of
which is due to the dry form of AMD, which represents approximately 90%
of all cases. GA is an advanced form of dry AMD which can be associated
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. The Company currently has three product
candidates in development: Emixustat hydrochloride for AMD, rebamipide
ophthalmic suspension for dry eye syndrome and OPA-6566 for ocular
hypertension and glaucoma, all of which are being co-developed in the
United States with Otsuka Pharmaceutical. Based on Acucela's core
technology, Visual Cycle Modulation (VCM), the investigational compound
emixustat hydrochloride is being evaluated to treat GA associated with
dry AMD. Rebamipide ophthalmic suspension, being developed for dry eye
syndrome in the United States, is marketed in Japan under the trade name
Mucosta® Ophthalmic Suspension UD2% by Otsuka Pharmaceutical. OPA-6566,
an adenosine A2a receptor agonist, is being investigated as an
ophthalmic solution for lowering intraocular pressure in open-angle
glaucoma or ocular hypertension patients under a co-development
agreement with Otsuka Pharmaceutical.
(1) 2012 Comprehensive Report on The Global Retinal
Pharmaceuticals & Biologics Market, Market Scope.
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