SEATTLE, WA I August 27, 2013 I 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). 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 for 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 with blindness.
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 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.
SOURCE: Acucela
Post Views: 87
SEATTLE, WA I August 27, 2013 I 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). 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 for 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 with blindness.
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 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.
SOURCE: Acucela
Post Views: 87
