FDA grants priority review to possible treatment for DR

May 1, 2006

The Food and Drug Administration (FDA) granted priority reviewstatus to Eli Lilly & Co.'s ruboxistaurin mesylate (proposedbrand name Arxxant), a possible treatment for diabetic retinopathy(DR).

The FDA granted priority review status to Eli Lilly & Co.'s ruboxistaurin mesylate (proposed brand name Arxxant), a possible treatment for diabetic retinopathy (DR).

In a phase III clinical trial, ruboxistaurin significantly reduced the occurrence of sustained moderate visual loss in patients being treated for moderate-to-very-severe DR. The 3-year trial involved 685 patients.

More than 2,000 patients have been treated with ruboxistaurin in clinical trials. Some patients have taken the drug for up to 4 years. No significant safety issues have been identified in any of the clinical trials.