Eleven Biotherapeutics begins phase 3 trial for dry eye solution
A clinical-stage biopharmaceutical company announced Tuesday that it has begun patient randomization and dosing in the next phase of a study for a dry eye treatment.
Eleven Biotherapeutics of Cambridge, Mass., is in the beginning stages of the company's first phase 3 clinical study of EBI-005, a topical ophthalmic solution, according to a press release.
EBI-005 was developed by the company's AMP-Rx platform, intended as a treatment for dry eye disease and allergic conjunctivitis. It is a topical interleukin-1 (IL-1) receptor blocker, according to the company.
The trial, listed as a multicenter, double-masked, randomized and controlled efficacy and safety study, will include about 650 participants, as detailed in the release. Researchers intend to measure changes in corneal fluorescein staining scores as well as changes in pain and discomfort. They will also analyze the EBI-005 solution compared to a vehicle control.
According to the release, Eleven Biotherapeutics expects top-line data from the study to be available in early 2015.