Fast track designated for ACU-4429

Bothell, WA, and Tokyo

-Acucela Inc. and Otsuka Pharmaceutical Co. Ltd. have received fast-track designation from the FDA for ACU-4429, an investigational oral treatment for dry age-related macular degeneration (AMD), according to the companies.

“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,” said Ryo Kubota, MD, PhD, chairman, president, and chief executive officer of Acucela.

ACU-4429 is designed to slow the eye’s visual cycle for processing light. By accomplishing this goal, the drug in preclinical trials has demonstrated the ability to decrease the levels of toxic by-products in the eye, thereby showing potential to stop the advance of dry AMD. The drug is administered to patients daily in pill form rather than via injection into the eye.

Otsuka Pharmaceutical and Acucela have forged a strategic partnership to co- develop ACU-4429 for dry AMD, as well as other potential indications in North America. After presenting phase I data at several medical conferences last year, the companies in January launched a phase II clinical trial of ACU- 4429, the ENVISION (Evaluating a Novel VISION treatment for AMD) Clarity Trial, in patients with dry AMD.