Lilly: Drug cuts diabetics' vision loss
Company says studies find Arxxant cuts risk of sight problems by 41%; FDA decision due in August.
WASHINGTON (CNNMoney.com) - An experimental drug from Eli Lilly & Co. reduces the risk of vision loss in diabetics, who often suffer declining eyesight, according to studies released Sunday.
Arxxant reduced the risk of vision loss in diabetics by 41 percent, according to data from two Lilly-funded late-stage studies, which compared the experimental drug to a placebo. The three-year studies focused on 813 patients, and found that declining vision occurred in 6.1 percent of patients taking Arxxant, also known as ruboxistaurin, compared to 10.2 percent in those taking placebo.
The findings, announced at the American Diabetes Association's annual conference, are important because retinopathy, or vision loss, affects 40 to 45 percent of all diabetics, according the National Institutes of Health. The potential patient pool is considerable because the ADA estimates that there 20.8 million diabetics in America.
Dr. Lloyd Aiello of the Harvard-affiliated Joslin Diabetes Center, the lead independent investigator in the studies, said Arxxant could be used to prevent about 70,000 cases of diabetic vision loss in America, if the numbers in the study are applied to the nation as a whole.
However, Arxxant no longer attracts the blockbuster-sized analyst projections that it used to, because earlier Arxxant studies regarding nerve disease in diabetics failed to meet objectives. Nerve disease, or neuropathy, is one of the more gruesome diabetic complications, because it can lead to amputation.
"It will probably get some use [as a vision loss drug,] but because the efficacy is not dramatic, most people have light estimates," said Jon LeCroy, analyst for Natexis Bleichroeder, who projects peak annual sales of $250 million.
Lilly filed its Arxxant application to the Food and Drug Administration in February. The FDA gave the application priority review status, which is generally perceived as a good sign for potential approval. The agency is scheduled to announce its decision in August. In addition, Lilly has been testing the drug as a treatment for diabetic kidney disease.
Also from the American Diabetes Association conference: