September 2016
Volume 57, Issue 12
Open Access
ARVO Annual Meeting Abstract  |   September 2016
Phase 3 Multi-Center Trial Evaluating the Efficacy, Safety and Tolerability of Isunakinra (EBI-005) in Subjects with Moderate to Severe Allergic Conjunctivitis
Author Affiliations & Notes
  • Michael H Goldstein
    Ophthalmology, New England Eye Center, Boston, Massachusetts, United States
    Eleven Biotherapeutics, Cambridge, Massachusetts, United States
  • Leontia Burke
    Eleven Biotherapeutics, Cambridge, Massachusetts, United States
  • Karen L Tubridy
    Eleven Biotherapeutics, Cambridge, Massachusetts, United States
  • Karen Dewar
    Eleven Biotherapeutics, Cambridge, Massachusetts, United States
  • Paul J Gomes
    Ora, Inc., Andover, Massachusetts, United States
  • Footnotes
    Commercial Relationships   Michael Goldstein, Eleven Biotherapeutics (E); Leontia Burke, Eleven Biotherapeutics (E); Karen Tubridy, Eleven Biotherapeutics (E); Karen Dewar, Eleven Biotherapeutics (C); Paul Gomes, Ora, Inc. (E)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science September 2016, Vol.57, 307. doi:
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      Michael H Goldstein, Leontia Burke, Karen L Tubridy, Karen Dewar, Paul J Gomes; Phase 3 Multi-Center Trial Evaluating the Efficacy, Safety and Tolerability of Isunakinra (EBI-005) in Subjects with Moderate to Severe Allergic Conjunctivitis
      . Invest. Ophthalmol. Vis. Sci. 2016;57(12):307.

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

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Abstract

Purpose : Although many patients with acute allergic conjunctivitis (AC) are well controlled, large numbers with late phase AC are inadequately treated or require steroids. Isunakinra (EBI-005) is a novel topical interleukin-1 receptor inhibitor being developed for the treatment of these patients. In a previously conducted phase 2 study in subjects with AC, isunakinra showed a statistically significant improvement in ocular itching, tearing and total nasal symptoms compared with vehicle control. Based on these results, we conducted a phase 3 study to evaluate topical isunakinra compared with vehicle control in subjects who had previously failed conventional topical antihistamine/mast cell stabilizer therapy.

Methods : In this multi-center, randomized, double-masked, vehicle-controlled study, 258 patients with moderate to severe allergic conjunctivitis were randomized to topical isunakinra or vehicle control, 1:1 at 11 clinical sites in the United States. Subjects were treated 3x/day over 4 weeks in the environmental setting. The primary endpoint was ocular itching. Ocular redness, ocular tearing, and total nasal symptoms were also evaluated during the study. Daily pollen counts and patient diaries were monitored. A cohort of subjects also underwent repetitive, daily challenge with a direct conjunctival allergen (CAC) for three days after completing the environmental portion of the study.

Results : Treatment was generally safe and well tolerated in this study. Drop out rate was low (below 10%). In addition to AC, randomized subjects also suffered from nasal allergies (86%) and systemic allergies (45%).

Conclusions : Isunakinra is a novel, topical interleukin-1 receptor inhibitor being developed to treat subjects with allergic conjunctivitis who have failed standard-of-care therapy. In this clinical study, treatment 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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