Phase III trial of EBI 005 fails to meet endpoints in Dry Eye Disease-Eleven Biotherapeutics

Eleven Biotherapeutics has announced top-line results from the OASIS pivotal Phase III study of EBI 005, in moderate to severe dry eye disease. The co-primary endpoints of the study were the total corneal fluorescein staining score and the patient-reported measurement related to ocular pain and discomfort based on the ocular surface disease index (OSDI), comparing the mean change from baseline at week 12 for treatment with EBI 005 to treatment with vehicle control.

In this study, EBI005 did not meet either of these two co-primary endpoints. There was no statistically significant difference between the EBI 005 treated group and the vehicle control group on the co-primary endpoints or any secondary endpoints. Patients with dry eye disease in both the EBI 005 and vehicle treatment groups showed statistically significant improvement from baseline on the co-primary endpoints. While the change from baseline on the co-primary endpoints was greater in the vehicle group than the EBI 005 group, the differences between the two groups were not statistically significant and the company believes the differences were not clinically meaningful. EBI 005 was generally well tolerated.