The company now plans to submit a new drug application to the FDA, supported by the phase III results, for the drug in the vision loss indication. The company says that the drug, if approved, will be the first oral medication for the treatment of diabetic retinopathy on the market.
However, the company has also completed a more disappointing late phase study on Arxxant to treat a separate diabetic condition that causes nerve function deterioration with symptoms including numbness, tingling and pain. In this study the drug did not show significant efficacy in treating the condition, and as such the company has been left with no alternative but to suspend its plans to submit a new drug application for Arxxant in this indication.
“While we are disappointed in the outcome of the trials for SDPN, we are extremely pleased to be one step closer to providing a possible solution for patients with diabetic retinopathy,” said Dr Steven Paul, executive vice president of science and technology at Eli Lilly and Company.
Eli Lilly’s shares were down 1.5% in the wake of these announcements.