Eye Disease

With the acquisition of Eyetech Pharmaceuticals in late 2005, OSI has established a third disease area in which to apply its innovative science in a specialty healthcare arena. Macugen was approved by the FDA in December 2004 and in the EU in January 2006 on the basis of its demonstrated ability to stabilize vision in patients suffering from the “wet” form of age-related macular degeneration. The Phase III ‘VISION’ studies that led to the approval of Macugen enrolled all kinds of patients including many with advanced AMD. Recently published and presented data suggest that Macugen may be even more effective by improving vision in some patients with newly diagnosed wet AMD and the two-year safety data from the “VISION” studies suggest that Macugen’s excellent safety record could be a competitive advantage especially in elderly patients, many of whom have cardiovascular risk factors.

We believe Macugen could become a primary anti-VEGF combination therapy of choice and be used as a maintenance therapy throughout the long-term course of managing this disease. Macugen is also being developed for additional indications such as diabetic macular edema (DME) – a debilitating form of diabetic retinopathy, where it is in Phase III trials, and in central retinal vein occlusion.

According to the World Health Organization, diabetic retinopathy is the leading cause of blindness in working-age adults and a leading cause of vision loss in diabetics; some 500,000 people in the U.S. have DME with some 75,000 new cases each year. It is also important to note that diabetes generally affects a much younger patient population than those suffering from wet AMD. As such, Macugen’s strong safety profile could prove invaluable in the long-term management of this disease.