pSivida Corp


Diabetic Macular Edema / ILUVIEN®

Our lead development product, Iluvien is licensed to Alimera Sciences, Inc. and utilizes the third generation of the Durasert technology. The US Food and Drug Administration (FDA) approved Iluvien for the treatment of Diabetic Macular Edema (DME) for patients treated with a course of corticosteroids and did not have a significant rise in intraocular pressure (IOP).

Additionally, ILUVIEN® for Diabetic Macular Edema (DME), has received marketing authorization in 17 EU countries. These marketing authorizations followed a positive outcome of the European Decentralized Procedure. ILUVIEN, licensed to Alimera Sciences Inc. (Alimera), is approved for use in the treatment of vision impairment associated with chronic DME considered insufficiently responsive to available therapies.

ILUVIEN is an injectable, non-erodible, intravitreal implant for the treatment of DME, a potentially blinding condition that affects approximately one million people in the U.S. alone. ILUVIEN is designed to release the drug fluocinolone acetonide (FA) for up to three years. Importantly, the device is small enough to be injected into the back of the eye with a 25 gauge needle creating a self-sealing hole. This insertion procedure is very similar to an intravitreal injection, a procedure commonly employed by retinal specialists.

DME is a common complication of diabetic retinopathy and is caused by fluid build-up in the central vision portion of the retina. Retinal blood vessels in a diabetic's eyes deteriorate and leak, causing retinal swelling.


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