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Acucela Announces Initiation of Phase 2b/3 Clinical Trial of Emixustat Hydrochloride (formerly known as ACU-4429) in Subjects with Geographic Atrophy (GA) Associated with Dry Age-Related Macular Degeneration (AMD)

2013年04月25日 AM06:25
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SEATTLE

Acucela Inc., a clinical-stage biotechnology company focused on developing new treatments for sight threatening eye diseases, today announced that a phase 2b/3 clinical trial investigating emixustat hydrochloride in subjects with geographic atrophy (GA) associated with dry age-related macular degeneration (AMD) has been initiated. 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. Emixustat hydrochloride is being studied to determine whether it slows the progression of GA in patients with GA associated with dry AMD.

The SEATTLE study was initiated based on data from the recently completed phase 2a study, the results of which will be announced at the ARVO 2013 Annual Meeting, as well as feedback from the U.S. Food and Drug Administration (FDA). ARVO will be held here in Seattle, Washington from May 5-9, 2013.

“Acucela is committed to developing new and innovative ophthalmic products where there exists an unmet or underserved medical need and emixustat hydrocholoride is a prime example of this commitment,” stated Ryo Kubota, MD, PhD, chairman, president and CEO, Acucela Inc. “Today’s announcement represents a significant milestone for not only Acucela, but for the emixustat hydrochloride program and potentially for patients worldwide. Emixustat hydrochloride, the first internally developed compound for Acucela, has a unique mechanism of action in visual cycle modulation, offers oral dosing and the ability to specifically target the visual cycle, representing a potentially novel therapeutic approach for the treatment of retinal diseases, such as GA associated with dry AMD.”

Pravin U. Dugel, MD, Managing Partner, Retinal Consultants of Arizona, stated, “In my practice, we see many patients who suffer from dry AMD and who are at risk of developing GA, so the start of this clinical trial is an exciting milestone. A drug that could address GA, while also being delivered in a pill form, would mark a dramatic step forward in the way this debilitating eye disease may be treated.”

About The Safety and Efficacy Assessment Treatment Trials of Emixustat Hydrochloride (the SEATTLE) Study

The SEATTLE study of emixustat hydrochloride is designed as a phase 2b/3 multicenter, randomized, double-masked, dose-ranging study comparing the efficacy and safety of emixustat hydrochloride with placebo for the treatment of geographic atrophy (GA) associated with dry age-related macular degeneration (AMD). Approximately 440 patients with GA associated with dry AMD will be enrolled in the study across 56 sites, primarily in the United States.

About Dry Age-related Macular Degeneration (AMD)

There are more than 10 million people in the US and more than 120 million people worldwide who 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, representing approximately 90% of all cases. Dry AMD occurs when the light-sensitive cells in the back of the eye slowly deteriorate, gradually blurring the central field of vision. As the disease advances, and where patients typically present with GA, the blurred vision slowly progresses to blindness in affected areas of the eye.

About Acucela Inc.

Acucela Inc. (www.acucela.com or www.acucela.jp) 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 age-related macular degeneration, 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, the investigational compound emixustat hydrochloride is being evaluated to treat GA associated with dry age-related macular degeneration. The Company also intends to leverage the VCM technology to develop treatments for diseases such as: diabetic retinopathy/diabetic macular edema, Stargardt’s disease and retinopathy of prematurity. 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.

1The Retinal Pharmaceuticals Market Report, Market Scope, 2012.

CONTACT

Acucela Inc.
Francesca T. Nolan, 206-805-8308
Director
Corporate Communications
francesca.nolan@acucela.com

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