Promising Dry AMD Treatment Moves into Phase II Clinical Trial

An oral medication for the dry form of age-related macular degeneration (AMD) is moving into a Phase II clinical trial after showing positive results for safety and effectiveness in prior preclinical studies and a Phase I human trial. Developed by Acucela, the drug works by slowing the buildup of toxic waste products that lead to retinal degeneration and vision loss in dry AMD.

Currently, there are virtually no treatments for dry AMD, a common, progressive condition causing significant vision loss in seniors. Ninety percent of people with AMD have the dry form, and are also at risk of developing the wet form of AMD, which causes sudden and severe vision loss. Collectively, both forms of AMD are the leading cause of blindness in people 55 and older.

Dr. Ryo Kubota, Acucela’s chairman and chief executive officer, notes that the drug, ACU-4429, has an excellent safety profile thus far. He says that because the drug is a non-retinoid, meaning it was not derived from vitamin A, it has the potential to be safe for a wide range of people, including young patients and women of child-bearing age.

“We are excited to see this medication move forward for dry AMD, because so few treatment options exist for this prevalent vision-robbing condition,” says Stephen Rose, Ph.D., chief research officer, Foundation Fighting Blindness. “The drug’s mechanism of action, the slowing of waste and toxin buildup, may also make it a beneficial treatment for people with Stargardt disease. The upcoming Phase II study will give us more information on the drug’s safety profile and vision-saving potential.”

Acucela is currently recruiting participants with dry AMD for the Phase II clinical trial of ACU-4429. Known as the ENVISION Clarity Trial, the study is taking place at multiple sites throughout the U.S. Acucela is planning to enroll at least 56 participants in the study. Participants will receive either the drug or a placebo.

For more information about the trial contact:

Covance Clinical Research Unit in Dallas, Laura Lonsdale at (214) 920-9053;
Covance Clinical Research Unit in Austin, David Carter at (512) 302-6519; or
Visit http://www.clinicaltrials.gov and search on “Acucela”

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