Eleven Biotherapeutics completes patient enrollment in dry eye study

Eleven Biotherapeutics has finished enrolling patients in its phase 3 clinical study of EBI-005 in patients with dry eye disease, the company announced.

According to the press release, EBI-005 is a novel topical interleukin-1 receptor blocker and is currently being evaluated for the treatment of dry eye disease and allergic conjunctivitis.

“The completion of patient enrollment in this study in dry eye disease is another key milestone in our development of EBI-005,” Abbie Celniker, PhD, president and chief executive officer of Eleven Biotherapeutics, said in the release. “Over half of the subjects have completed the study, and we look forward to reporting top-line results in the second quarter of 2015.”

The company reported that 650 patients have been enrolled in the OASIS study (a multicenter, double-masked, randomized, controlled, efficacy and safety study of EBI-005 5 mg/mL topical ophthalmic solution vs. vehicle control in subjects with moderate to severe dry eye disease).

Patients will either receive EBI-005 or a vehicle-control for 12 weeks at one of the 45 study centers in the U.S. After this period, a safety assessment will be conducted for 3 weeks, according to the release.

Researchers will be looking for a change in total corneal fluorescein staining score as well as an improvement in ocular discomfort.

According to Eleven Biotherapeutics, EBI-005 has also been assessed in a phase 2 study for moderate to severe allergic conjunctivitis, in which it failed to meet its primary endpoint.