PRODUCTS / ILUVIEN®
ILUVIEN®
Iluvien® (sustained release fluocinolone acetonide) for the treatment of diabetic macular edema (DME) is our lead development product. On June 29, 2010 our licensee, Alimera Sciences, submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Ilvuien for DME. In the submission, Alimera requested priority review, which, if granted, could result in an action letter from the FDA in the fourth quarter of 2010. Alimera has also announced the submission of a Marketing Authorization Application to the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom (UK) for Iluvien. The MAA was submitted through the Decentralized Procedure with the UK MHRA as the Reference Member State . Applications have also been submitted to the following other Concerned Member States in the EU: Austria, France, Germany, Italy, Portugal and Spain.
Two pivotal Phase III clinical trials, collectively known as the FAME study (Fluocinolone Acetonide in Diabetic Macular Edema), are being completed to assess te efficacy and safety of Iluvien for the treatment of DME. In December 2009, we announced positive data from the 24 month analysis of the Phase III clinical trials. The NDA submission includes the 24-month low dose data from the FAME study.
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 US. Iluvien is designed to release the drug fluocinolone acetonide (FA) for up to periods of 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. The Iluvien Phase III clinical trials enrolled 956 patents in over 100 sites in the United States, Canada, Europe and India.
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
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.
