Exciting Times for Macular Degeneration

An offer from OSI Pharmaceuticals to buy Eyetech Pharmaceuticals has energized both the business and science communities in the world of macular degeneration research.

Age-related macular degeneration (AMD) is a degenerative disease of the central portion of the retina that results in loss of central vision in the affected eye. Central vision is required for activities such as driving, reading, and watching television, in addition to many of the tasks of daily life. Age-related macular deneration is classified as dry (atrophic type) or wet (neovascular type). Wet AMD is characterized by the growth of abnormal vessels in the retina, which can leak, leading to fluid collections or bleeding under the retina. This leaking fluid can result in retinal detachment, leading to vision loss.

Wet AMD results in a rapid distortion and loss of central vision over a period of weeks to months. Once wet AMD has developed in one eye, the other eye is at high risk of developing the disease. In a large study, wet AMD was found in 0.9 percent of all people, but in no one under the age of 55. The prevalence of the disease increased with age.

As many as 15 million people suffer from some form of AMD, with more than 1.6 million of these being the wet type of AMD. There are 500,000 new cases of wet AMD worldwide each year. Although wet AMD is not nearly as common as dry AMD, wet AMD causes significantly more severe vision loss. Wet AMD represents about 10 percent of all AMD cases but is responsible for as much as 90 percent of the severe vision loss accociated with AMD.

Why all of the new excitement? Eyetech Pharmaceuticals has the first and only product on the U.S. market for treating wet AMD. However, biotech giant Genentech is close behind with a new product of their own in clinical trials. And today, OSI Pharmaceuticals offered to buy Eyetech in a cash and stock deal.

Eyetech Pharmaceuticals, Inc., is a biopharmaceutical company specializing in therapeutics to treat diseases of the eye. In December 2004, their first product, pegaptanib sodium injection, marketed under the name Macugen, was approved by the United States Food and Drug Administration for use in the treatment of all types of wet AMD. They began selling their product on the U.S. market in January 2005. Macugen is also being tested in clinical trials for the treatment of diabetic macular edema and retinal vein occlusion, both significant causes of vision loss. Macugen was named Innovative Product of the Year in 2005 by the Pharmaceutical Achievement Awards. Macugen is the first and only FDA-approved therapy for the treatment of all subtypes of wet AMD. Macugen is being co-promoted with Pfizer.

However, Genentech has ranibizumab (Lucentis) in Phase III clinical trials for the potential treatment of the wet form of AMD. Lucentis is being developed in collaboration with Novartis Ophthalmics. On May 24th, 2005, Genentech released preliminary data showing that Lucentis had unprecedented efficacy against some types of AMD and may even help reverse the disease.

Up to this point, OSI Pharmaceuticals had focused on cancer and diabetes products, but appears eager to get into the ring with Genentech. Interestingly, OSI Pharmaceuticals currently is co-promoting another product, Tarceva, with Genentech.

What does this all mean? There is one exciting product already on the market for wet AMD and another one likely to be on the market soon. This is good news for the millions of people suffering from the disease and should make for interesting time for biopharmaceutical investors.