FDA takes closer look at retinophathy drug

Indianapolis-Eli Lilly & Co.'s ruboxistaurin mesylate (proposed brand name Arxxant), a possible treatment for diabetic retinopathy, has received priority review status by the FDA.

In preclinical trials, data showed that ruboxistaurin inhibits the activity of the protein kinase C beta enzyme. Overactivation of this enzyme has been linked to the underlying process of microvascular damage, caused by diabetes.

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 diabetic retinopathy. This 3-year trial involved 685 patients.