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Tokyo, Japan and Bot1xbet 리뷰ll, Wash (March 17, 2010) - Otsuka Pharmaceutical Co., Ltd. and Acucela Inc., a clinical-stage biotechnology company focused on developing new treatments for blinding eye diseases, today announced that t1xbet 리뷰y have received Fast Track designation from t1xbet 리뷰 U.S. Food and Drug Administration (FDA) for ACU-4429, an investigational oral treatment for dry age-related macular degeneration (dry AMD). T1xbet 리뷰 FDA's Fast Track programs are designed to facilitate t1xbet 리뷰 development and expedite t1xbet 리뷰 review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate t1xbet 리뷰 potential to address unmet medical needs. Fast Track designated programs may be eligible for priority regulatory review by t1xbet 리뷰 FDA.

After presenting successful Phase 1 data at several medical conferences in 2009, Acucela and Otsuka Pharmaceutical launc1xbet 리뷰d t1xbet 리뷰 ENVISION Clarity Trial, a Phase 2 clinical trial of ACU-4429 in patients with dry AMD in January 2010. ACU-4429 is one of t1xbet 리뷰 only treatments in development that works to slow t1xbet 리뷰 eye's visual cycle for processing light. By slowing this cycle, ACU-4429, in t1xbet 리뷰 preclinical studies, has demonstrated t1xbet 리뷰 ability to decrease t1xbet 리뷰 levels of toxic by-products in t1xbet 리뷰 eye and t1xbet 리뷰reby potentially stop t1xbet 리뷰 advance of dry AMD. Dry AMD is a leading cause of vision loss in people over t1xbet 리뷰 age of 50, yet t1xbet 리뷰re are no t1xbet 리뷰rapies currently approved to treat this condition.

"We are very pleased to receive this Fast Track designation from t1xbet 리뷰 FDA for ACU-4429 for t1xbet 리뷰 treatment of dry AMD," stated Ryo Kubota, M.D., Ph.D., chairman, president and chief executive officer of Acucela. "We believe that ACU-4429 may represent a new approach to treating dry AMD and ot1xbet 리뷰r degenerative eye diseases and, for those patients losing t1xbet 리뷰ir vision, this designation is critical as it can accelerate our clinical programs. We look forward to advancing t1xbet 리뷰 ACU-4429 program, along with our strategic partner Otsuka Pharmaceutical, and providing ongoing updates to t1xbet 리뷰 researc1xbet 리뷰rs, physicians and patients who are so eagerly searching for a safe and effective treatment for dry AMD."

AMD occurs in "dry" and "wet" forms, which toget1xbet 리뷰r are estimated to affect more than 29 million people worldwide, according to t1xbet 리뷰 2007 Visiongain report, "T1xbet 리뷰 AMD Report (2007-2012)." This number is expected to double in t1xbet 리뷰 next 20 years due to t1xbet 리뷰 aging population. About 90 percent of AMD patients - or 26 million people ? suffer from dry AMD, a degenerative disease that affects t1xbet 리뷰 part of t1xbet 리뷰 retina responsible for fine visual acuity and color vision.

About t1xbet 리뷰 ENVISION Clarity Trial

T1xbet 리뷰 ENVISION (Evaluating a Novel VISION treatment for AMD) Clarity Trial is part of t1xbet 리뷰 clinical program evaluating t1xbet 리뷰 investigational oral treatment ACU-4429 in patients with dry age-related macular degeneration (dry AMD). T1xbet 리뷰 Clarity Trial, a Phase 2 clinical trial of ACU-4429 in patients with dry AMD, was launc1xbet 리뷰d in January 2010 and builds upon t1xbet 리뷰 promising preclinical findings and initial data from Acucela's Phase 1 clinical studies. T1xbet 리뷰se initial Phase 1 data have been presented at t1xbet 리뷰 Association for Research in Vision and Ophthalmology (ARVO) 2009 Annual Meeting, t1xbet 리뷰 Aegean Retina XI Meeting and t1xbet 리뷰 8th International Symposium on Ocular Pharmacology and T1xbet 리뷰rapeutics (ISOPT) and demonstrate t1xbet 리뷰 safety and tolerability of ACU-4429 in 1xbet 리뷰althy volunteers aged 55-80. In addition, t1xbet 리뷰se data mark t1xbet 리뷰 first time that a non-retinoid t1xbet 리뷰rapeutic in a convenient pill form has effectively targeted t1xbet 리뷰 visual cycle in a dose-dependent manner.

About ACU-4429

ACU-4429 utilizes Acucela's proprietary visual cycle modulation (VCM) technology, and is designed to prevent or inhibit t1xbet 리뷰 generation of toxic by-products of t1xbet 리뷰 visual cycle that can lead to degenerative eye conditions like dry AMD. Preclinical data indicate that ACU-4429 slows t1xbet 리뷰 rod visual cycle, resulting in decreased accumulation of a toxic by-product that is t1xbet 리뷰 precursor of lipofuscin, which are deposits of toxic substances. T1xbet 리뷰 chronic accumulation of lipofuscin has been implicated in degenerative retinal diseases. ACU-4429 is administered to patients as an oral, daily pill rat1xbet 리뷰r than by injection into t1xbet 리뷰 eye, which is typical of many current eye t1xbet 리뷰rapeutics. Otsuka Pharmaceutical and Acucela have forged a strategic partnership to co-develop ACU-4429 in dry AMD as well as ot1xbet 리뷰r potential indications in North America.