PRODUCTS / ILUVIEN™
ILUVIEN™
ILUVIEN™ (sustained release fluocinolone acetonide) is our lead development product. It has completed Phase III clinical trials for the treatment of diabetic macular edema. These trials called the FAME study (Fluocinolone Acetonide in Diabetic Macular Edema), were conducted in conjunction with our partner Alimera Sciences Inc. Our jointly owned NDA was recently submitted to the FDA. We have licensed certain drug delivery technology to Alimera Sciences for the development of ILUVIEN and certain other ophthalmic products. In addition to the FAME study, Alimera is conducting a Phase II clinical trial with ILUVIEN in wet and dry age-related macular degeneration (AMD) and Retinal Vein Occlusion (RVO).
ILUVIEN is an injectable, non-erodable, 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.
