Skip to main content

DE-109 FDA Approval Status

FDA Approved: No
Brand name: DE-109
Generic name: sirolimus
Dosage form: Intravitreal Injection
Company: Santen Pharmaceutical Co., Ltd.
Treatment for: Uveitis

DE-109 (sirolimus) is a locally-administered, non-steroidal immunoregulator in development for the treatment of non-infectious uveitis of the posterior segment (NIU-PS).

Development timeline for DE-109

Dec 21, 2017Santen Receives Complete Response Letter from U.S. FDA for Intravitreal Sirolimus (DE-109)
Apr 25, 2017Santen Announces U.S. FDA Filing Acceptance of New Drug Application (NDA) for Intravitreal Sirolimus (DE-109) in the Treatment of Non-Infectious Uveitis of the Posterior Segment

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.