Diabetic retinopathy (DR) occurs when diabetes damages the small blood vessels in the retina, a part of the eye that is needed for vision. This damage can lead to vision loss and possible blindness.
This phase III clinical trial examined whether Arxxant could reduce the risk of long-term, or sustained moderate vision loss caused by non-proliferative diabetic retinopathy. Vision loss occurred in only 5.5% of patients treated with Arxxant compared to 9.1% of patients treated with placebo, equaling a 40% relative risk reduction over three years.
Patient discontinuations due to adverse events were not statistically different between treatment groups. There were 36 patient deaths none of which were considered by the investigator or sponsor to be related to study drug.
Eli Lilly is currently challenging a decision by the FDA that requested an additional phase III study of Arxxant before it could be approved.