pSivida Corp


Diabetic Macular Edema / ILUVIEN™

Our most recenttly approved product ILUVIEN™ for Diabetic Macular Edema (MDE), has received marketing authorization in the UK, Austria, France, Germany, Portugal and Spain. These marketing authorizations followed a positive outcome of the European Decentralized Procedure. ILUVIEN, licenses to Alimera Sciences Inc. (Alimera), is approve 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. Currently, the only FDA approved method for treating DME involves laser photocoagulation therapy, which can leave irreversible blind spots. Currently there is no FDA approved drug therapy for the treatment of DME.

Phase II clinical trials in wet-age related macular edema (wet-AMD) are currently being conducted at the Wilmer Eye Institute at Johns Hopkins University. Phase II clinical trials in dry-age related macular edema (dry-AMD) are being conducted at the Kresge Eye Institute at Wayne State University.

Links to additional information:

Information on AMD study »