Drug Shown to Cut Diabetics’ Vision Loss

By RICK CALLAHAN

INDIANAPOLIS – An experimental Eli Lilly and Co. drug reduced vision loss in diabetics by inhibiting an enzyme that damages the eye’s light-sensing retina, according to the results of two clinical trials.

In the late-stage trials funded by Lilly, patients who received ruboxistaurin had 41 percent less moderate vision loss than those who received a placebo during the three-year studies.

Among the 813 patients in the studies, researchers found declining vision in 6.1 percent of those taking the drug, compared with 10.2 percent in those taking placebo. The results were presented Sunday in Washington D.C., during the American Diabetes Association’s annual scientific meeting.

The Indianapolis-based drug maker is seeking regulatory approval to market the product under the brand name Arxxant as the first oral treatment for diabetic retinopathy, a disorder that can cause blindness. The U.S. Food and Drug Administration is expected to make a decision by August.

“This is really the first drug that’s been shown to have an impact on actual vision, which is the most important thing to the patient,” said Dr. Louis Vignati, medical director for the Lilly team that developed the drug.

However, one analyst said the drug’s potential as a broad treatment for the condition appears limited.

Vignati said the studies show that Arxxant works by reducing levels of an enzyme that damages tiny blood vessels in the retina – the light-sensing tissue at the back of the eye – in patients with severe diabetic eye disease.

Diabetic retinopathy affects at least one-third of the world’s estimated 230 million diabetics. The drug could allow many diabetics to continue driving cars and take part in everyday activities, Vignati said.

It could also spare others the need for laser therapy on the retina, which is the typical treatment for severe diabetic eye disease, he said.

Although Arxxant slowed vision loss by reducing damage to retinal blood vessels, it failed to prevent the disease from advancing into the more serious stage in which the growth of new blood vessels in the retina often causes bleeding inside the eye, leading to clouded vision.

An investment research report released Sunday by Deutsche Bank states that “Arxxant’s luster and potential” has faded because the studies completed to date “have demonstrated only moderate activity with no clear impact on disease progression.”

“Our view is that its impact will minimal,” said Deutsche Bank analyst Barbara Ryan. “We just don’t think it’s going to be that important from a commercial standpoint.”

Lilly shares fell 13 cents to $51.61 in trading on Monday on the New York Stock Exchange.

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