September 2016
Volume 57, Issue 12
Open Access
ARVO Annual Meeting Abstract  |   September 2016
A Phase 3 Multi-Center, Randomized Controlled Evaluation of the Efficacy, Safety and Tolerability of Isunakinra in Subjects with Moderate to Severe Dry Eye Disease
Karen L. Tubridy, PharmD 1 Michael H. Goldstein, MD, 1,2 Marianne Magill, MS 1
1
Eleven Biotherapeutics (Cambridge, MA)
2 New England Eye Center, Tuft's Medical Center (Boston, MA)
Author Affiliations & Notes
  • Karen L Tubridy
    Development, Eleven Biotherapeutics, Cambridge, Massachusetts, United States
  • Michael H Goldstein
    Development, Eleven Biotherapeutics, Cambridge, Massachusetts, United States
    New England Eye Center, Tuft's Medical Center, Boston, Massachusetts, United States
  • Marianne Magill
    Consultant, Natick, Massachusetts, United States
  • Footnotes
    Commercial Relationships   Karen Tubridy, Eleven Biotherapeutics (E); Michael Goldstein, Eleven Biotherapeutics (E); Marianne Magill, Eleven Biotherapeutics (C)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science September 2016, Vol.57, 2874. doi:
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      Karen L Tubridy, Michael H Goldstein, Marianne Magill; A Phase 3 Multi-Center, Randomized Controlled Evaluation of the Efficacy, Safety and Tolerability of Isunakinra in Subjects with Moderate to Severe Dry Eye Disease
      Karen L. Tubridy, PharmD 1 Michael H. Goldstein, MD, 1,2 Marianne Magill, MS 1
      1
      Eleven Biotherapeutics (Cambridge, MA)
      2 New England Eye Center, Tuft's Medical Center (Boston, MA). Invest. Ophthalmol. Vis. Sci. 2016;57(12):2874.

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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 dry eye disease (DED) and allergic conjunctivitis (AC). The purpose of this Phase 3 study was to evaluate the efficacy, safety, and tolerability of isunakinra in subjects with moderate to severe dry eye.

Methods : In this double-masked, vehicle-controlled study, 669 subjects at 46 sites in the USA with moderate to severe dry eye disease (DED) were randomized to topical isunakinra or vehicle control 1:1. Subjects were treated 3x/day for 12 weeks. Co-primary efficacy assessments were mean change from baseline at week 12 for total corneal fluorescein staining score (CFS, sign), and the OSDI pain question (symptom). Safety and tolerability of isunakinra were assessed.

Results : Of the 669 subjects, 334 received vehicle-control and 335 received isunakinra; 92% completed the study. There were 33 drop outs in the isunakinra group and 20 in the vehicle control group. Baseline demographics of the two groups were similar. Isunakinra was generally safe and well tolerated in this study. No treatment related serious adverse events were reported. There was no statistically significant difference between the isunakinra treated group and the vehicle control group for the co-primary endpoints. Subjects in both the isunakinra and vehicle treatment groups showed statistically significant improvement from baseline on the co-primary endpoints as early as one week.

Conclusions : In this study, isunakinra was generally safe and well tolerated and had a similar adverse event profile to vehicle and to earlier studies conducted with isunakinra. Isunakinra showed a statistically significant improvement compared to baseline for signs and symptoms of DED over the 12 week treatment period, however there was no statistically significant difference between the isunakinra and vehicle-control subjects for the study endpoints.

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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