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Acucela Announces Publication in Retina Showcasing First-Time Demonstration of Dose-Dependent Visual Cycle Modulation with an Oral, Non-Retinoid Therapy.

Paper Highlights Phase 1 Clinical Results for Innovative ACU-4429 Program, Now in Phase 2 ENVISION Clarity Trial in Dry AMD

SEATTLE -- Acucela Inc., a clinical-stage biotechnology company focused on developing new treatments for blinding eye diseases, today announced the publication of a new paper in Retina: The Journal of Retinal and Vitreous Diseases evaluating the safety and tolerability of ACU-4429, a novel, small-molecule visual cycle modulator (VCM). The paper was co-authored by Ryo Kubota, M.D., Ph.D., chairman, president and chief executive officer of Acucela, along with collaborators from Retina Foundation of the Southwest and Otsuka Pharmaceutical, and details the first-time demonstration of a non-retinoid therapeutic in a convenient, oral pill form effectively targeting the visual cycle in a dose-dependent manner.

Published by Lippincott Williams & Wilkins, RETINA focuses exclusively on the growing specialty of vitreoretinal disorders. The Journal contains highly specialized and informative, peer-reviewed articles providing the most current information on diagnostic and therapeutic techniques.

The paper highlights data from a Phase 1 study assessing the safety, tolerability, pharmacokinetics and pharmacodynamics of ACU-4429 administration in healthy volunteers aged 55-80. This Phase 1 trial was a single-center, randomized, double-masked, placebo-controlled, dose-escalation study. Data from the trial demonstrated a well-tolerated, dose-dependent modulation of the visual cycle using electroretinography (ERG), an established eye test in the evaluation of response and recovery of the retina that is used to help diagnose disease. These data have also been highlighted at the International Symposium on Ocular Pharmacology and Therapeutics (ISOPT).

"We believe the results from this study further illustrate the significant potential for ACU-4429 in the treatment of dry AMD, for which there is no approved therapy and a vast unmet medical need," said Dr. Kubota. "In this paper, my co-authors and I have demonstrated the potential of visual cycle modulation as a promising therapeutic approach for patients suffering from degenerative eye diseases. These data further support our ongoing Phase 2 study of ACU-4429 as part of the ENVISION Clarity Trial."

The paper, titled "Safety and effect on rod function of ACU-4429, a novel small-molecule visual cycle modulator" is available in the online publication of Retina at http://journals.lww.com/retinajournal/.

Age-related macular degeneration (AMD) is a chronic degenerative disease of the retina and is the most common cause of visual loss among the elderly population, affecting more than 29 million people worldwide. Dry AMD accounts for approximately 85 percent of all AMD cases and there is currently no approved treatment for the disease.

About ACU-4429

ACU-4429 utilizes Acucela's proprietary visual cycle modulation (VCM) technology, and is designed to prevent or inhibit the generation of toxic by-products of the visual cycle that can lead to degenerative eye conditions like dry AMD. In 2010, ACU-4429 was granted Fast Track designation by the U.S. Food and Drug Administration. Data indicate that ACU-4429 slows the rod visual cycle, resulting in decreased accumulation of a toxic by-product that is the precursor of lipofuscin, which are deposits of toxic substances. The chronic accumulation of lipofuscin has been implicated in degenerative retinal diseases. ACU-4429 is administered to patients as an oral, daily pill rather than by injection into the eye, which is typical of many current eye therapeutics. Acucela has forged a strategic partnership with Otsuka Pharmaceutical, Co. Ltd. to co-develop ACU-4429 in dry AMD as well as other potential indications in North America.

About the ENVISION Clarity Trial

The ENVISION (Evaluating a Novel VISION treatment for AMD) Clarity Trial is part of the clinical program evaluating the investigational oral treatment of ACU-4429 in patients with dry age-related macular degeneration (dry AMD). The Clarity Trial, a Phase 2 clinical trial of ACU-4429 in patients with dry AMD, was launched in January 2010 and builds upon the promising preclinical findings and initial data from Acucela's Phase 1 clinical studies. The Phase 1a clinical results, presented at ARVO, Aegean Retina XI and ISOPT and published in the journal Retina, demonstrated that ACU-4429 was safe and tolerable in healthy volunteers aged 55-80; and dose-dependent modulation of the visual cycle was shown in electroretinography (ERG) measurement, an eye test used to detect abnormal function of the retina (the light-detecting portion of the eye). The ENVISION Clarity Phase 2 trial is a randomized, double-masked, placebo-controlled study of three planned escalating dose levels of ACU-4429 and up to two additional dose levels in subjects with dry AMD. Patients will receive either ACU-4429 or placebo orally once daily for three months. The trial will be conducted at multiple sites throughout the U.S. and is overseen by an independent Data Monitoring Committee that will recommend each escalation in dose.

About Acucela Inc.

Acucela Inc. (www.acucela.com) is a clinical-stage biotechnology company focused on leveraging promising science in visual cycle modulation (VCM) to develop new methods for treating blinding eye diseases that affect tens of millions of people worldwide. The company's orally-delivered VCM therapies, which selectively target cells within the retina to protect visual acuity, have the potential to be used to treat several devastating eye diseases, including dry age-related macular degeneration (AMD), for which there is currently no treatment options for patients; retinopathy of prematurity, Stargardt disease and diabetic retinopathy. ACU-4429 for dry AMD is being co-developed by Acucela and Otsuka Pharmaceutical Co., Ltd. in North America, and the companies are also co-developing Rebamipide for dry eye and OPA-6566 for glaucoma in the United States. Acucela was founded by Ryo Kubota, M.D., Ph.D., a pioneer in the ophthalmology field and the discoverer of the gene that causes glaucoma.
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Date:Apr 25, 2011
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