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[IP] Lilly: Drug cuts diabetics' vision loss

Lilly: Drug cuts diabetics' vision loss
 Company says studies find Arxxant cuts risk of sight problems by 41%; FDA
decision due in August.
By Aaron Smith, CNNMoney.com staff writer
June 11, 2006: 6:16 PM EDT

 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

 "This vision loss can't be corrected with the use of glasses, nor is it likely
that any drug will restore the vision," said Dr. Louis Vignati, Arxxant medical
director for Lilly (Research).

 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

 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.

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