Eli Lily debates potential DR treatment

Indianapolis, IN-Eli Lilly and Co. said it is "weighing its options" regarding further development of ruboxistaurin mesylate after the FDA requested an additional 3-year, phase III clinical trial of the molecule that could treat severe nonproliferative diabetic retinopathy.

The FDA requested the additional efficacy data in late September, more than a month after issuing an approvable letter for the molecule. The company said it thinks such a trial would require up to 5 years to complete.

"We are certainly disappointed with this communication from the FDA," said John Lechleiter, PhD, the company's president and chief operating officer. "We still believe that ruboxistaurin has potential as a treatment for diabetic eye disease and are exploring the feasibility of further development of this molecule."

Lilly had given the investigational oral therapy the proposed trade name of Arxxant. The first of a new class of compounds, the therapy works by limiting the overactivation of protein kinase C beta, an enzyme linked to the development of diabetic retinopathy.

Lilly and Alcon Inc. had signed a long-term agreement in late July to co-promote the treatment in the United States and Puerto Rico, subject to FDA approval.