Acucela begins phase 2b/3 clinical trial of emixustat hydrochloride to treat GA associated with dry AMD

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.

“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”

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."