Eli Lilly and Company has completed a Phase 3 clinical trial in which its investigational drug, ruboxistaurin mesylate (proposed brand name Arxxant) reduced the occurrence of vision loss in patients with diabetic retinopathy (DR). As a result, Lilly believes it is appropriate to submit a new drug application (NDA) to the US Food & Drug Administration at the end of 2005 for the treatment of DR, the initial indication for ruboxistaurin.
In addition, Lilly has announced that two Phase 3 clinical trials to determine the effect of ruboxistaurin on treatment of sensory symptoms associated with diabetic peripheral neuropathy (SDPN) have been completed. In these studies, statistical comparison of the change in sensory symptom scores between the placebo and ruboxistaurin-treated groups did not demonstrate significant differences and did not meet the studies' primary endpoints —a regulatory requirement for submission. Consequently, these results do not support the NDA filing for SDPN.
"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, Executive Vice President, Science and Technology, Eli Lilly and Company. "If ruboxistaurin is approved by the FDA, it would be the first oral medication for the treatment of this serious complication of diabetes," he added.
Diabetic retinopathy and diabetic peripheral neuropathy (DPN) are diabetic microvascular complications (DMCs). Nearly 75 percent of all people with diabetes have at least one DMC.
Diabetic retinopathy (DR) is a condition that leads to progressive damage to the small blood vessels of the eye, and can lead to vision loss and possible blindness. According to the World Health Organization and the American Diabetes Association, DR is the leading cause of vision loss in adults of working age (20 to 65 years) in industrialized countries.
Ruboxistaurin is a specific protein kinase C beta (PKC beta) inhibitor, the first of a new class of compounds being investigated for the treatment of diabetic retinopathy (DR) and diabetic peripheral neuropathy (DPN).