Acucela, Otsuka Pharmaceutical granted FDA Fast Track designation for ACU-4429 in treatment of dry AMD

Acucela Inc., a clinical-stage biotechnology company focused on developing new treatments for blinding eye diseases, and Otsuka Pharmaceutical Co., Ltd., today announced that they have received Fast Track designation from the U.S. Food and Drug Administration (FDA) for ACU-4429, an investigational oral treatment for dry age-related macular degeneration (dry AMD). The FDA’s Fast Track programs are designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Fast Track designated programs may be eligible for priority regulatory review by the FDA.

“We are very pleased to receive this Fast Track designation from the FDA for ACU-4429 for the treatment of dry AMD”

After presenting successful Phase 1 data at several medical conferences in 2009, Acucela and Otsuka Pharmaceutical launched the ENVISION Clarity Trial, a Phase 2 clinical trial of ACU-4429 in patients with dry AMD in January 2010. ACU-4429 is one of the only treatments in development that works to slow the eye’s visual cycle for processing light. By slowing this cycle, ACU-4429, in the preclinical studies, has demonstrated the ability to decrease the levels of toxic by-products in the eye and thereby potentially stop the advance of dry AMD. Dry AMD is a leading cause of vision loss in people over the age of 50, yet there are no therapies currently approved to treat this condition.

“We are very pleased to receive this Fast Track designation from the FDA for ACU-4429 for the treatment of dry AMD,” stated Ryo Kubota, M.D., Ph.D., chairman, president and chief executive officer of Acucela. “We believe that ACU-4429 may represent a new approach to treating dry AMD and other degenerative eye diseases and, for those patients losing their vision, this designation is critical as it can accelerate our clinical programs. We look forward to advancing the ACU-4429 program, along with our strategic partner Otsuka Pharmaceutical, and providing ongoing updates to the researchers, physicians and patients who are so eagerly searching for a safe and effective treatment for dry AMD.”

AMD occurs in “dry” and “wet” forms, which together are estimated to affect more than 29 million people worldwide, according to the 2007 Visiongain report, “The AMD Report (2007-2012).” This number is expected to double in the next 20 years due to the aging population. About 90 percent of AMD patients – or 26 million people – suffer from dry AMD, a degenerative disease that affects the part of the retina responsible for fine visual acuity and color vision.