Eli Lilly plans to file a new drug application for ruboxistaurin after a Phase III trial showed it was effective in preventing the loss of vision among patients with diabetic retinopathy. Lilly added, though, that two other Phase III studies probing the effect of ruboxistaurin on the treatment of sensory symptoms associated with diabetic peripheral neuropathy did not hit their primary endpoints and would not be submitted in an NDA. No safety issues were raised in the clinical trials, Lilly said.
"While we are disappointed in the outcome of the trials for SDPN, we are extremely pleased to be one step closer to providing a possible solution for patients with diabetic retinopathy," said Dr. Steven Paul, Lilly's Executive Vice President, Science and Technology. "If ruboxistaurin is approved by the FDA, it would be the first oral medication for the treatment of this serious complication of diabetes."
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