Eli Lilly and Company announced Nov. 13 results from a three-year phase 3 clinical trial which showed its as yet unapproved drug Arxxant (ruboxistaurin mesylate) reduced the risk of sustained moderate vision loss by 40 percent for patients with moderate to severe non-proliferative diabetic retinopathy.

The multi-center, 36-month, placebo-controlled, phase 3 clinical trial involved 685 patients at 70 clinical sites who received either a placebo or 32 mg per day of Arxxant. Full results of the study will be published in the December 2006 issue of the journal Ophthalmology.

Researchers reported that in the study, vision loss occurred in only 5.5% of patients treated with Arxxant compared to 9.1% of patients treated with a placebo, equaling a 40 percent relative risk reduction over three years.

Vision loss was defined as a three-line loss on a standard eye chart that was sustained for at least 6 months.

Patient discontinuations due to adverse events were not statistically different between treatment groups. There was no consistent pattern of adverse events to suggest a causal relationship between Arxxant and any spontaneously reported adverse event, the researchers reported.

An application for approval of Arxxant was submitted to the U.S. Food and Drug Administration in February, but the FDA has indicated it will require data from an additional Phase 3 study before acting. Lilly has decided to appeal the FDA's decision and has recently begun discussions with the agency.