Diabetic retinopathy drug reduced vision loss

INDIANAPOLIS — A drug in development for treatment of diabetic retinopathy reduced the occurrence of vision loss in a clinical trial, according to drug maker Eli Lilly and Co. The drug, ruboxistaurin mesylate, will be submitted to the Food and Drug Administration for premarket approval by the end of the year, according to a press release from the company.

The Lilly statement said phase 3 trial data indicate that ruboxistaurin — tentatively to be brand-named Arxxant — reduced the occurrence of vision loss in patients with diabetic retinopathy in the phase 3 trial.

Lilly also said ruboxistaurin completed phase 3 trials for a second indication, treatment of diabetic neuropathy, but the drug did not meet the primary endpoints in the neuropathy trial.

“While we are disappointed in the outcome of the trials for [diabetic peripheral neuropathy], we are extremely please to be one step closer to providing a possible solution for patients with diabetic retinopathy,” said Steven Paul, Lilly’s executive vice president for science and technology. “If ruboxistaurin is approved by the FDA, it would be the first oral medication for the treatment of this serious complication of diabetes.”

In the retinopathy trial, 685 patients with moderately severe to severe diabetic retinopathy received once-daily ruboxistaurin for 3 years. The primary outcome was a reduction in the occurrence of sustained moderate visual loss (defined as a doubling of the visual angle, for instance from 20/20 to 20/40) when compared to patients on placebo.

“This trial demonstrated a statistically significant reduction in this outcome,” Lilly said in its press release. Results of the phase 3 trial will be announced at a “major medical meeting” in late 2005 or early 2006, the company said.

An ongoing trial to determine the effect of ruboxistaurin on diabetic macular edema is expected to be complete in 2010, according to the company.

Ruboxistaurin is a specific protein kinase C beta inhibitor, the first in what Lilly called a new class of compounds being investigated for the vascular complications of diabetes.

In 2003, Lilly and Takeda signed an agreement to jointly develop and market ruboxistaurin in Japan.