Date: 2014-11-03
Type of information: Completion of patient enrollment
phase: 3
Announcement: completion of patient enrollment
Company: Eleven Biotherapeutics (USA - MA)
Product: EBI-005
Action
mechanism: EBI-005 is a topical, novel interleukin-1 (IL-1) receptor blocker in development as a protein therapeutic for dry eye disease and allergic conjunctivitis. The EBI-005 program is based on the role that elevated levels of the inflammatory cytokine IL-1 play in the initiation and maintenance of the inflammation and pain associated with dry eye disease and the itching and other symptoms associated with allergic conjunctivitis. EBI-005 has been evaluated in a Phase 2 study in patients with moderate to severe allergic conjunctivitis and is currently being evaluated in a pivotal Phase 3 study in dry eye disease.
Disease: dry eye disease
Therapeutic area: Ophtalmological diseases
Country: USA
Trial
details: The OASIS study (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) is being conducted at 45 study centers across the United States. In this study, 650 patients with moderate to severe dry eye disease have been enrolled and randomized for treatment with either EBI-005 or vehicle-control for a period of 12 weeks followed by a three week safety assessment. The co-primary endpoints of the study are change in total corneal fluorescein staining score (a sign of dry eye disease) and improvement in ocular pain and discomfort (a symptom of dry eye disease). The safety and tolerability of EBI-005 compared to vehicle-control will also be evaluated. This pivotal Phase 3 trial was designed based on the results observed in Eleven’s Phase 1b/2a clinical trial of EBI-005 in patients with moderate to severe dry eye disease.
Latest
news: * On November 3, 2014, Eleven Biotherapeutics, a clinical-stage biopharmaceutical company discovering and developing protein therapeutics to treat diseases of the eye, announced the completion of patient enrollment in its first pivotal, Phase 3 clinical study of EBI-005 in patients with dry eye disease. The company looks forward to reporting top-line results in the second quarter of 2015.
