21 December 2017 - Santen Pharmaceutical today announced that the U.S. FDA has issued a complete response letter for the new drug application for intravitreal sirolimus (DE-109). 

Intravireal sirolimus is an investigational therapy developed as a potential treatment for adults with non-infectious uveitis of the posterior segment, a leading cause of preventable blindness in working-age adults.

The complete response letter indicates that the FDA is unable to approve the application in its present form and requests additional substantiating evidence to demonstrate efficacy of intravitreal sirolimus in the treatment of non-infectious uveitis of the posterior segment.

Read Santen press release