The company is developing its DE-109 product to treat people with noninfectious uveitis of the posterior segment, which can cause blindness in adults.
Santen reported that the FDA’s complete response letter requested additional, substantiating evidence to prove DE-109’s efficacy.
“We are evaluating the FDA’s response and will work closely with the agency to determine the best path forward. We strongly believe in the benefits of IVT sirolimus for noninfectious uveitis of the posterior segment patients, and will continue to work towards our goal of bringing a local, non-steroidal therapy to patients suffering from this sight-threatening disease,” Dr. Naveed Shams, head of global R&D and chief scientific officer, said in prepared remarks.
“Santen remains focused on our mission to develop and provide innovative therapies to patients suffering from ophthalmic diseases in the United States and around the world.”
The company also noted that the FDA’s rejection is not expected to materially change its full-year earnings forecasts for 2017.