Eli Lilly: Ruboxistaurin demonstrates promise in reducing vision loss caused by diabetes

By E. Janene Geiss

Philadelphia, June 12 - Eli Lilly and Co. announced Sunday results from an analysis of pooled data from two, three-year phase 3 trials that showed ruboxistaurin mesylate reduced the risk of sustained moderate vision loss by 41% when compared to a placebo in patients with moderate to severe, nonproliferative diabetic retinopathy.

Vision loss occurred in only 6.1% of patients treated with ruboxistaurin compared to 10.2% of patients treated with a placebo, according to a company news release.

Ruboxistaurin is an investigational drug for the treatment of diabetic retinopathy, a diabetic eye disease. Its proposed brand name is Arxxant.

The findings were presented at the American Diabetes Association's annual scientific sessions in Washington, D.C.

The findings also were included in the company's New Drug Application, which was submitted to the Food and Drug Administration in February.

Comprised of data from two studies, the combined analysis examined a total of 813 patients treated with 32 mg per day of ruboxistaurin or a placebo derived from two multi-center, randomized, placebo-controlled, double-masked, phase 3 trials that were similar in design and implementation.

The analysis examined whether ruboxistaurin could reduce the risk of long-term, or sustained moderate vision loss caused by diabetic retinopathy. Patients had moderate to severe nonproliferative diabetic retinopathy at the start of the study.

The beneficial effect of ruboxistaurin was not accompanied by a reduction in the progression of study patients from nonproliferative to proliferative diabetic retinopathy, officials said.

A separate analysis of data from 11 studies of the safety of 32 mg per day of ruboxistaurin in patients with at least one diabetic microvascular complication also was presented at the scientific sessions.

That analysis found ruboxistaurin was generally well-tolerated and had an overall adverse event profile, as well as a serious adverse event profile, similar to a placebo, officials said.

Serious adverse events occurred in 23.2% of patients taking a placebo compared to 20.8% of patients taking ruboxistaurin. And ruboxistaurin had no effect on glucose or blood pressure control, officials said.

Eli Lilly is an Indianapolis pharmaceutical products company.

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