September 2016
Volume 57, Issue 12
Open Access
ARVO Annual Meeting Abstract  |   September 2016
A Multi-Center Phase 3 Safety and Tolerability Study of Isunakinra (EBI-005) in Subjects with Moderate to Severe Dry Eye Disease
Author Affiliations & Notes
  • Leontia Burke
    Clinical Operations, Eleven Biotherapeutics, Cambridge, Massachusetts, United States
  • Michael H Goldstein
    Development, Eleven Biotherapeutics, Cambridge, Massachusetts, United States
    New England Eye Center, Tufts Medical Center, Boston, Massachusetts, United States
  • Karen L Tubridy
    Development, Eleven Biotherapeutics, Cambridge, Massachusetts, United States
  • Footnotes
    Commercial Relationships   Leontia Burke, Elevenbiotherapeutics (E); Michael Goldstein, Eleven Biotherapeutics (E); Karen Tubridy, Eleven Biotherapeutics (E)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science September 2016, Vol.57, 2872. doi:
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    • Get Citation

      Leontia Burke, Michael H Goldstein, Karen L Tubridy; A Multi-Center Phase 3 Safety and Tolerability Study of Isunakinra (EBI-005) in Subjects with Moderate to Severe Dry Eye Disease. Invest. Ophthalmol. Vis. Sci. 2016;57(12):2872.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : Isunakinra (EBI-005) is a novel topical interleukin-1 receptor inhibitor optimized for topical treatment of ocular surface diseases such as allergic conjunctivitis (AC) and dry eye disease (DED). Isunakinra is currently being evaluated in a phase 3 study in subjects with moderate to severe allergic conjunctivitis. The purpose of this study is to evaluate the safety and efficacy of isunakinra in subjects with moderate to severe dry eye disease.

Methods : In this randomized, double-masked, vehicle-controlled study, 104 patients at 9 sites in the United States with moderate to severe dry eye disease (DED) were randomized to topical isunakinra or vehicle control 3:1. Subjects were treated 3x/day for 3 months or 6 months. Safety and tolerability was assessed throughout the study.

Results : Isunakinra was generally safe and well tolerated in this study. 102 subjects completed treatment with study medication for 3 months and 32 subjects completed 6 months treatment. Drop out rate was low (below 5%).

Conclusions : Isunakinra is a novel topical interleukin-1 receptor inhibitor being developed for the topical treatment of subjects with ocular surface diseases such as allergic conjunctivitis and dry eye disease. In this clinical study, isunakinra was generally safe and well tolerated.

This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.

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