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Ruboxistaurin may reduce vision loss in DME
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INDIANAPOLIS — The drug ruboxistaurin may reduce vision loss in patients with diabetic macular edema, according to new analysis of data from two large phase 3 trials.
The new analysis was presented by Lloyd Paul Aiello, MD, PhD, at the American Academy of Ophthalmology in New Orleans. Ruboxistaurin is being developed by Eli Lilly and Co.
Dr. Aiello reported on data from two phase 3 placebo-controlled trials of ruboxistaurin in patients with diabetic eye disease — one group that had been followed for 30 months and another that had been followed for at least 3 years. Total enrollment in the two trials was more than 900 patients, the company noted.
In patients who had equivalent levels of edema in the center of the macula, those who received 32 mg per day of ruboxistaurin had better visual acuities than placebo-treated patients. There were about 63 patients in each group, according to the press release.
In addition, there was a trend toward less progression of diabetic macular edema to the center of the macula in patients receiving 32 mg of ruboxistaurin than in patients receiving placebo, in a separate trial with 170 patients per treatment group.
“These data suggest that ruboxistaurin may have the potential to decrease the progression of diabetic macular edema to involve the center of the macula. A phase 3 clinical trial is under way to further explore these preliminary findings,” Dr. Aiello said, in a press release from Lilly.
Ruboxistaurin is a specific inhibitor of PKC-beta, an enzyme that has been implicated in the underlying process of microvascular damage, according to the Lilly release.