Lilly delays filing for diabetic ocular drug

INDIANAPOLIS — Eli Lilly and Co. will delay regulatory filing on a drug it is developing for the treatment of diabetic retinopathy and diabetic macular edema, according to a news release from the company. The delay comes because disease progression in a placebo group was much lower than expected, the release said.

Lilly’s ruboxistaurin mesylate protein kinase C inhibitor, also known as LY333531, completed two clinical trials, one for diabetic macular edema (DME) and the other for diabetic retinopathy (DR). Lilly executives say the European submission delay was caused by a much lower than expected overall rate of disease progression in the placebo group, a key factor in the studies’ not meeting primary end points.

In the DME study, however, the drug demonstrated that patients with a baseline hemoglobin level of 11% or less experienced a statistically significant and clinically important reduction in time to progression of DME. In the DR trial, the number of patients with sustained visual loss as determined by visual acuity decreased.

Lilly plans “to pursue a global submission of ruboxistaurin for the treatment of diabetic retinopathy, diabetic macular edema and diabetic peripheral neuropathy,” said August Watanabe, MD, Lilly’s executive vice president of science and technology.

The company expects to file its first European submission for the drug for the treatment of symptoms of diabetic peripheral neuropathy in 2004, the same time it expects to file for U.S. approval.