Eleven Biotherapeutics Begins Phase 3 Study With EBI-005 In Dry Eye Disease

(RTTNews) - Eleven Biotherapeutics (EBIO), a clinical-stage biopharmaceutical company discovering and developing protein therapeutics to treat diseases of the eye, said that patient randomization and dosing are underway in the company's first pivotal Phase 3 trial of EBI-005 for the treatment of moderate to severe dry eye disease, the OASIS study.

The OASIS study is a multi-center, double-masked, randomized, controlled, efficacy and safety study of EBI-005 5 mg/mL topical ophthalmic solution versus vehicle control in subjects with moderate to severe dry eye disease.

EBI-005, the firm's most advanced product candidate generated using its AMP-Rx platform, is a novel, topically administered Interleukin-1 (IL-1) receptor blocker currently in development for the treatment of dry eye disease and allergic conjunctivitis. EBI-005 was designed to bind and block the IL-1 receptor to prevent transmission of biological signals responsible for many of the signs and symptoms of ocular surface diseases.

This pivotal Phase 3 trial would include nearly 650 subjects in the U.S., who would be randomized to receive EBI-005 or a vehicle-control. The co-primary endpoints of the study are change in corneal fluorescein staining score and improvement in pain and discomfort. Also, the safety and tolerability of EBI-005 compared to vehicle-control would be assessed. The firm expects top line data from this pivotal Phase 3 study to be available in early 2015.