Eli Lilly drug reduces diabetic vision loss

An experimental drug by a global pharmaceutical company - Eli Lilly indicated promise in reducing vision loss caused by the effects of diabetes on the retina, according to combined data from a pair of late-stage clinical trials presented on Sunday.

In a meeting at the American Diabetes Association in Washington, the lead investigators of the study said clinical trial data showed investigational treatment Ruboxistaurin, which is expected to be sold under the brand name Arxxant if approved, reduced the risk of sustained moderate vision loss by 41% compared to placebo in patients with moderate to severe diabetic retinopathy (DR).

The two studies, conducted over three years, involved 813 patients who received either 32 milligrams of ruboxistaurin or a placebo. The study revealed that the vision loss occurred in only 6.1% of patients treated with ruboxistaurin compared to 10.2% of patients treated with placebo.

Dr. Lloyd Paul Aiello, lead investigator of the study, said in an interview, "It's a completely new approach that can help slow down loss of vision," he further added, "Many people fear blindness more than death and this gives another chance to prevent or delay blindness from the disease."

One of the world's largest corporations, Eli Lilly submitted a new drug application (NDA) to solicit approval from the US Food and Drug Administration (FDA) for Ruboxistaurin for the treatment of diabetic retinopathy in February 2006.

The FDA has notified Indiana, United States based Lilly that it will conduct a priority review of Lilly's NDA submission for Ruboxistaurin.

Eli Lilly is a leading global manufacturer and distributor of pharmaceutical therapies for cancer, cardiovascular disease, central nervous system and endocrine system disorders, infectious diseases, and other diagnoses, and if approved, Lilly's Ruboxistaurin could be the first pill to hew the risk of vision loss caused by diabetic retinopathy.

Presently, laser treatments are employed to treat the disease, which is widespread among diabetics.

In initial stages of diabetic retinopathy, blood vessels in the retina can leak, harming vision. In the more severe, augmentative stage, a profusion of fragile new blood vessels form in the back of the eye that are particularly prone to such leaking, further damaging vision.

Combining the Ruboxistaurin with vision, Aiello said, "Vision is the main concern and the drug seems to work at the earlier stage of the disease in preventing vision loss."