Addressing the Ophthalmic 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 proprietary inserter with a 25 gauge needle, which allows for a self-sealing wound. The location where the retinal specialist places Iluvien in the back of the eye takes advantage of the eye’s natural fluid dynamics to deliver FA to the retina. 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.

Clinical Trials

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 in support of a planned global registration filing, with safety and efficacy assessed after 24 months of follow-up. In December 2009, the preliminary readout occured. Please see the "News" section for more information.

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

Diabetic Vision Loss and Blindness

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 2007, the Centers for Disease Control and Prevention estimated the prevalence of diabetes in the United States to be 23.6 million persons or 7.8 percent of the population and is believed to be growing at a rapid rate. Over time, all diabetics are at risk of developing some form of diabetic retinopathy, an ophthalmic condition of diabetes. In the U.S., diabetic retinopathy causes approximately 12,000 to 24,000 new cases of blindness each year, making diabetes the leading cause of new cases of blindness in adults aged 20 to 74.

There are no ophthalmic drug 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.