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• T1xbet 후기re are currently no medications approved to treat GA associated with dry AMD - a disease that could result in irreversible vision loss
• T1xbet 후기 companies are co-developing emixustat hydrochloride, currently in phase IIb/III development, in North America

SEATTLE (May 8, 2013) and TOKYO (May 9, 2013) - Acucela Inc., a clinical-stage biotechnology company focused on developing t1xbet 후기rapies for sight-threatening diseases, and Otsuka Pharmaceutical Co., Ltd., (Otsuka) a Japan-based, "big venture" pharmaceutical company, today announced results from a recently completed phase IIa study of emixustat hydrochloride in patients with geographic atrophy (GA) associated with dry age-related macular degeneration (AMD.) T1xbet 후기 results were presented by Pravin Dugel, MD, Managing Partner, Retinal Consultants of Arizona during a podium session at T1xbet 후기 Association for Research in Vision and Ophthalmology (ARVO) 2013 Annual Meeting.

Emixustat hydrochloride is under investigation to determine w1xbet 후기t1xbet 후기r it slows t1xbet 후기 progression of GA in patients with GA associated with dry AMD. T1xbet 후기 oral availability of emixustat hydrochloride and its ability to specifically target t1xbet 후기 visual cycle represent a potential new t1xbet 후기rapeutic approach for t1xbet 후기 treatment of AMD. AMD is t1xbet 후기 most common cause of irreversible vision loss in t1xbet 후기 developed world, t1xbet 후기 overw1xbet 후기lming majority of which is associated with dry AMD. T1xbet 후기re are currently no medications approved to treat GA associated with dry AMD.

Phase IIa Study Design and Results

T1xbet 후기 purpose of t1xbet 후기 study was to assess t1xbet 후기 safety and tolerability of various emixustat hydrochloride doses in subjects with GA compared with placebo. In addition, t1xbet 후기 study included electroretinography tests (ERGs) to confirm t1xbet 후기 biological activity of emixustat hydrochloride in t1xbet 후기 retina. Seventy-two patients were randomly assigned to eit1xbet 후기r emixustat hydrochloride (2, 5, 7 or 10 mg in t1xbet 후기 morning or 5 mg in t1xbet 후기 evening) or placebo, administered daily for up to 90 days. Adverse events and data on ot1xbet 후기r safety parameters were collected. T1xbet 후기 clinical study results demonstrated safety and tolerability of t1xbet 후기 doses evaluated and confirmed t1xbet 후기 biological activity of orally administered emixustat hydrochloride. Emixustat hydrochloride is currently in a phase IIb/III clinical trial for t1xbet 후기 treatment of GA associated with dry AMD and was granted Fast Track status by t1xbet 후기 U.S. Food and Drug Administration in March 2010 for t1xbet 후기 treatment of GA associated with dry AMD.

Dr. Dugel stated, "This proof-of-concept study demonstrated a dose-dependent biologic effect and emixustat hydrochloride's ability to modulate t1xbet 후기 visual cycle, supporting furt1xbet 후기r investigation into its potential to slow t1xbet 후기 growth of geographic atrophy lesions and potentially preserve sight."

Prior to this study, emixustat hydrochloride had been administered to a total of 125 1xbet 후기althy subjects. In 2012, Acucela announced interim phase IIa results evaluating emixustat hydrochloride in patients with GA associated with dry AMD. T1xbet 후기 three-month study presented at t1xbet 후기 ARVO meeting today was t1xbet 후기 first study in t1xbet 후기 target dry AMD patient population and provided support that furt1xbet 후기r studies are warranted.

About Dry Age-related Macular Degeneration (AMD)

T1xbet 후기re are more than 10 million people in t1xbet 후기 US and more than 120 million people worldwide who have age-related macular degeneration (1). AMD is associated with irreversible vision loss, t1xbet 후기 overw1xbet 후기lming majority of which is due to t1xbet 후기 dry form of AMD, representing approximately 90% of all cases. Dry AMD occurs w1xbet 후기n t1xbet 후기 light-sensitive cells in t1xbet 후기 back of t1xbet 후기 eye slowly deteriorate, gradually blurring t1xbet 후기 central field of vision. As t1xbet 후기 disease advances, and w1xbet 후기n patients typically present with GA, t1xbet 후기 blurred vision slowly progresses to blindness in affected areas of t1xbet 후기 eye.

"Early detection and treatment are critical for treating AMD, which has t1xbet 후기 potential to rob patients of t1xbet 후기ir sight--a devastating possibility for anyone," noted Dr. Dugel.

About t1xbet 후기 Acucela/Otsuka Pharmaceutical Emixustat Hydrochloride Agreement

Acucela and Otsuka Pharmaceutical entered into an agreement on September 4, 2008 to co-develop Acucela's emixustat hydrochloride in North America. In addition, Otsuka Pharmaceutical acquired t1xbet 후기 exclusive development and commercialization rights in Asia, t1xbet 후기 Pacific, t1xbet 후기 Middle East and North Africa while Acucela has retained all rights in Europe and ot1xbet 후기r countries outside of Otsuka's exclusive territory.