Table of Contents
NFB Icon

FDA Rejects Promising Diabetic Retinopathy Drug

by Gail Brashers-Krug

Just when it seemed that a medication to prevent diabetic retinopathy was on the horizon, the Food and Drug Administration has ruled that the Eli Lilly drug Arxxant (ruboxistaurin mesylate) must undergo three more years of clinical trials before approval.

The ruling was a blow to Lilly and to millions of diabetics with retinopathy. According to the National Eye Institute, between 40 and 45 percent of all diabetics have some degree of retinopathy—that is, damage to the tiny blood vessels in the eye caused by high blood sugar levels. Retinopathy ultimately causes not only vision loss, but eventually total blindness. In fact, diabetes is the leading cause of blindness in working-age adults, and approximately 20,000 Americans each year become blind as a result of diabetes.

The new Lilly drug would have been the first oral medication to fight retinopathy. It works by inhibiting the enzyme that causes damage to the tiny blood vessels in the eye, and could stop eye damage in its tracks. Early studies were promising and seemed to represent progress in the fight against retinopathy.

At this point, Arxxant’s fate is not clear. Lilly has invested ten years and untold millions of dollars developing the drug. The three-year clinical study required by the FDA will cost Lilly several million dollars more. Lilly is considering its options including conducting clinical trials, seeking new investors, or scrapping the project entirely. Many industry observers had expected Arxxant to be a potential money-maker for Lilly, possibly earning more than a billion dollars by 2010 as the number of Americans with diabetes continues to skyrocket.

The primary treatment for diabetic retinopathy is still laser surgery, although good diabetes self-management can slow or stop its progress. If you have not had a thorough eye exam in the last year, please schedule one. You may already have retinopathy, even if it is not yet interfering with your vision. The only way to detect it is with a thorough eye exam. Your eye doctor can help you take steps to protect your vision.