Patient Recruitment Continues for Trial of Promising Dry AMD Drug

October 03, 2013

 Acucela Inc., a Seattle-based developer of eye-disease therapies, is enrolling 440 patients across 56 sites for its three-year, Phase 2b/3 clinical trial of emixustat hydrochloride (formerly ACU-4429) for the treatment of advanced dry age-related macular degeneration (AMD), a vision-robbing retinal condition also known as geographic atrophy (GA). In August, the company reported that it reached 50 percent enrollment for the study.

Emixustat hydrochloride is an oral drug being developed to reduce the accumulation of toxins that cause damaging lesions in the central area of the retina in people with GA. The treatment is designed to slow the visual cycle — the biochemical process in the retina that makes vision possible. Preclinical research has shown that slowing the visual cycle reduces the production of harmful byproducts that lead to GA lesions. In a 90-day, 56-patient, Phase 2a clinical trial, emixustat hydrochloride slowed the visual cycle as determined by an electroretinogram, a test which measures the sensitivity of retinal cells.  

“There are virtually no treatments for dry AMD, yet it is a leading cause of blindness in the United States and other developed countries,” says Stephen Rose, Ph.D., chief research officer, Foundation Fighting Blindness. “We are very encouraged by the clinical advancement of Acucela’s dry AMD therapy. The current study will tell us more about the treatment’s potential for saving vision.”

Ten million people in the United States have AMD, approximately 90 percent of those the dry form. The condition can cause significant loss of central vision, affecting a person’s ability to read, drive and recognize the faces of loved ones. An over-the-counter supplement from the National Eye Institute’s Age-Related Eye Disease Study (AREDS) has been shown to reduce the risk of advanced AMD by 25 percent.

Recruitment information for the emixustat hydrochloride clinical trial is available at www.clinicaltrials.gov/show/NCT01802866.