Otsuka Pharmaceutical drug fast-tracked by FDA

Otsuka Pharmaceutical has received fast-track designation from the Food and Drug Administration (FDA) for a new treatment for dry age-related macular degeneration (AMD).

The regulator has granted this designation to ACU-4429, which was developed in collaboration between Otsuka and Acucela, due to its potential to address an urgent or unmet medical need.

In clinical trials, the new compound has already demonstrated its potential for stopping the advance of the condition by decreasing the levels of toxic by-products within the eye.

It is estimated that AMD affects more than 29 million people worldwide, but no therapies for the treatment of dry AMD have been approved by regulators thus far.

Dr Ryo Kubota, chairman, president and chief executive officer of Acucela, said: “We believe that ACU-4429 may represent a new approach to treating dry AMD and other degenerative eye diseases.”

Earlier this month, Otsuka Pharmaceutical published positive clinical trial data for cilostazol, a treatment for those affected by strokes.