FDA calls for more evidence in IVT sirolimus

The US Food and Drug Administration has issued a complete response letter (CRL) for the New Drug Application (NDA) for intravitreal (IVT) sirolimus (DE-109).

Under development by Japanese ophthalmic drugmaker Santen Pharmaceutical (TYO: 4536), IVT sirolimus – proposed trade name Ospiria - 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 IVT sirolimus in the treatment of non-infectious uveitis of the posterior segment.