FDA wants another trial of Lilly diabetic eye drug
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Eli Lilly and Co. said Friday that U.S. regulators want an additional three-year clinical trial for its treatment for eye problems brought on by diabetes.
Lilly said such a trial would take up to five years to complete. It said it is weighing options for the further development of the treatment, called ruboxistaurin mesylate.
The Food and Drug Administration is calling for additional efficacy data before it will consider approving the molecule for the treatment of moderate to severe diabetic retinopathy.
Last month, Lilly said it received a so-called “approvable letter” from the FDA, rather than approving the drug outright.
Some analysts had predicted the drug, which had the proposed trade name Arxxant, could have sales of $500 million a year.
“We still believe that ruboxistaurin has potential as a treatment for diabetic eye disease and are exploring the feasibility of further development of this molecule,” said Dr. John Lechleiter, Lilly president and chief operating officer, in a statement.
Lilly said ongoing clinical trials for ruboxistaurin will continue while Lilly evaluates options for its further development.
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