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 FA is inserted into the patient’s eye using a 25 gauge needle, which allows for a self-sealing wound.  The placement site of Iluvien FA takes advantage of the eye’s natural fluid dynamics to deliver FA to the back of the eye.  A single Iluvien FA 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 FA has the potential to improve vision while reducing common side effects of corticosteroids.

At an initial targeted dosing of either 0.2 micrograms or 0.5 micrograms of drug delivered to the retina per day, Iluvien FA will be releasing the smallest amount of drug among products currently undergoing clinical trials for treating DME.

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.

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.