Eleven Biotherapeutics agent improves allergic conjunctivitis symptoms

Eleven Biotherapeutics announced that a phase 2 exploratory study of EBI-005 showed significant improvements in ocular itching and tearing and associated nasal symptoms.

Study results for the interleukin-1 receptor inhibitor were published in Eye and Contact Lens.

According to a company press release, 159 subjects with moderate to severe allergic conjunctivitis were randomized to receive topical EBI-005 (5 mg/mL) or vehicle control three times a day. Patients were repeatedly challenged with allergen in an allergy chamber or with a modified direct conjunctival allergen challenge.

In the modified direct conjunctival allergen challenge model, those who received EBI-005 showed statistically significant improvements in ocular itching and tearing and nasal symptoms compared with vehicle control at the last two visits (visit 6 and visit 7), the company reported.

The prespecified primary endpoint of ocular itching was not met in the allergy chamber model.

The treatment was well tolerated with no serious adverse events, the company said.

The company stated that this confirms the clinical benefit of EBI-005 in the late phase inflammatory response and that it plans to begin a phase 2 clinical study in the second half of the year in patients with moderate to severe allergic conjunctivitis.

“We believe we have a clear understanding of an ideal trial design to evaluate the late-stage allergic response and are looking forward to initiating a phase 3 clinical study of EBI-005 in patients with moderate to severe allergic conjunctivitis in the second half of 2015,” Eleven Biotherapeutics CEO Abbie Celniker, PhD, said in the release.

Reference:

Goldstein MH, et al. Eye Contact Lens. 2015;41(3):145-155. doi: 10.1097/ICL.0000000000000152.