New Product: ILUVIEN®

ILUVIEN® — an intravitreal insert for the treatment of diabetic macular edema (DME)

Iluvien, which has the potential to be the first FDA-approved prescription product for DME, is a sustained release intravitreal insert. 

 Iluvien is inserted in the back of the patient’s eye to a position that takes advantage of the eye’s natural fluid dynamics. The proprietary inserter employs a 25-gauge needle, which allows for a self-sealing wound. Alimera submitted the Iluvien New Drug Application (NDA) to the FDA in June 2010, was granted Priority Review in August and has a PDUFA date of December 30, 2010. The Iluvien NDA submission was supported by 24-month low-dose data from the Phase 3 pivotal clinical trials (collectively known as the FAME™ Study) for Iluvien. Each Iluvien insert is designed to provide a therapeutic effect for up to 36 months by delivering sustained sub-microgram levels of fluocinolone acetonide (FA).

Alimera Iluvien