Iluvien™ Overview
Addressing the Crisis of Diabetes

Iluvien™, a tiny, intravitreal insert, is being studied as a way to deliver fluocinolone acetonide, a corticosteroid, to the retina for up to three years as a treatment for DME.

The Iluvien™ insert (see picture) is only 3.5mm in length and 0.37mm in diameter and is designed to provide a low daily dose of fluocinolone acetonide (FA), a non-proprietary corticosteroid with a history of treating ocular disease.  Iluvien is inserted into the patient’s eye using a 25 gauge needle, which allows for a self-sealing wound.  The placement site of Iluvien takes advantage of the eye’s natural fluid dynamics to deliver FA to the back of the eye.  A single Iluvien insert is designed to provide sustained therapy for 24 to 36 months.  By combining FA and a delivery device that provides for a unique long term, low dose delivery of FA to the back of the eye, we believe Iluvien has the potential to improve vision while reducing common side effects of corticosteroids.

A global clinical study, the FAME (Fluocinolone Acetonide in Diabetic Macular Edema) Study consists of two masked, randomized, multi-center trials that are fully enrolled with 956 patients in the U.S., Canada, Europe and India and will be followed for 36 months. The trials began in September 2005.

In our clinical trials we are studying two doses of Iluvien (a high dose with an initial release of approximately 0.45 micrograms (µg) per day and a low dose with an initial release of approximately 0.23 µg per day). Iluvien will be releasing the smallest amount of drug among products currently undergoing clinical trials for treating DME.

DME, a complication of diabetic retinopathy, is a disease affecting the macula, the part of the eye responsible for central vision.  When the blood vessel leakage of diabetic retinopathy causes swelling in the macula, it is referred to as DME.  In 2005, the Centers for Disease Control and Prevention estimated the prevalence of diabetes in the United States to be 20.8 million persons and is believed to be growing at a rapid rate. Research indicates that up to 10 percent of all diabetes patients develop DME during their lifetimes.

There are no therapies currently approved by the US Food and Drug Administration (FDA) for the treatment of DME.  The current standard of care, laser photocoagulation, has undesirable side effects including partial loss of peripheral and night vision.  While there are no drugs approved by the FDA for DME, there is growing clinical and empirical evidence that corticosteroids reduce edema associated with DME.