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.