September 2016
Volume 57, Issue 12
Open Access
ARVO Annual Meeting Abstract  |   September 2016
Treatment of Chronic Allergic Conjunctivitis with Sustained Release Dexamethasone Using a Modified Conjunctival Allergen Challenge (Ora-CAC®) Model
Author Affiliations & Notes
  • Deepa Mulani
    Clinical, Ocular Therapeutix Inc, Bedford, Massachusetts, United States
  • Eugene B McLaurin
    Total Eye Care, Memphis, Tennessee, United States
  • Carolyn Repke
    Philadelphia Eye Associates, Philadelphia, Pennsylvania, United States
  • Michelle Sato
    East West Eye Institute, Los Angeles, California, United States
  • Paul J Gomes
    ORA , Andover, Massachusetts, United States
  • Eric Ankerud
    Clinical, Ocular Therapeutix Inc, Bedford, Massachusetts, United States
  • Michael Bassett
    Ocular Therapeutix Inc, Bedford, Massachusetts, United States
  • Charles D Blizzard
    Ocular Therapeutix Inc, Bedford, Massachusetts, United States
  • Arthur Driscoll
    Ocular Therapeutix Inc, Bedford, Massachusetts, United States
  • Amar Sawhney
    Ocular Therapeutix Inc, Bedford, Massachusetts, United States
  • Footnotes
    Commercial Relationships   Deepa Mulani, Ocular Therapeutix (E); Eugene McLaurin, None; Carolyn Repke, None; Michelle Sato, None; Paul Gomes, Ocular Therapeutix (C); Eric Ankerud, Ocular Therapeutix (E); Michael Bassett, Ocular Therapeutix (E); Charles Blizzard, Ocular Therapeutix (E); Arthur Driscoll, Ocular Therapeutix (E); Amar Sawhney, Ocular Therapeutix (I)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science September 2016, Vol.57, 4021. doi:
  • Views
  • Share
  • Tools
    • Alerts
      ×
      This feature is available to Subscribers Only
      Sign In or Create an Account ×
    • Get Citation

      Deepa Mulani, Eugene B McLaurin, Carolyn Repke, Michelle Sato, Paul J Gomes, Eric Ankerud, Michael Bassett, Charles D Blizzard, Arthur Driscoll, Amar Sawhney; Treatment of Chronic Allergic Conjunctivitis with Sustained Release Dexamethasone Using a Modified Conjunctival Allergen Challenge (Ora-CAC®) Model. Invest. Ophthalmol. Vis. Sci. 2016;57(12):4021.

      Download citation file:


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

      ×
  • Supplements
Abstract

Purpose : To evaluate the safety and efficacy of DEXTENZA™ (sustained release dexamethasone) 0.4mg Intracanalicular Depot (Ocular Therapeutix, Bedford, MA) compared to placebo when placed in the canaliculus of the eye for the treatment of allergic conjunctivitis using a modified Conjunctival Allergen Challenge Model (CAC®) (ORA, Andover, MA).

Methods : DEXTENZA™ is an intracanalicular depot containing dexamethasone within a biodegradable PEG hydrogel matrix. It releases dexamethasone into the tear film over 4 weeks in a tapered fashion. DEXTENZA™ was evaluated in the first of two Phase 3 studies to treat allergic conjunctivitis. Subjects underwent a series of allergen challenges using a modified Ora-CAC model to induce the inflammatory component of chronic allergic conjunctivitis. After showing a reproducible allergen response for itching and redness, and meeting eligibility criteria, subjects were randomized (1:1) to receive either DEXTENZA™ or placebo depots, bilaterally. The primary efficacy endpoints of ocular itching and conjunctival redness were assessed at 7 days post-insertion, with scoring based on zero to 4 scales, with zero being symptom free, and 4 representing the most extreme. Subjects were followed at 2 and 4 weeks post-insertion to assess continued therapeutic effect.

Results : Seventy-three subjects were randomized to either DEXTENZA™ (n=35) or placebo (n=38). At 7 days post-insertion, a single DEXTENZA™ dose was statistically superior to placebo for ocular itching at all time points (3, 5, and 7 minutes post-CAC) through 4 weeks. The differences (p-values) observed between the treatment and placebo groups for itching were statistically significant, respectively: -1.02 (< 0.0001), -0.87(< 0.0001), and -1.04(< 0.0001) and met the current FDA definition for clinically significant treatment differences. A treatment benefit was observed for conjunctival redness, but statistical superiority was not demonstrated. No serious adverse events were noted in either group.

Conclusions : Overall, DEXTENZA™ treatment was shown to be efficacious and well tolerated. Treatment effects for ocular itching were significant at 1 through 4 weeks post-treatment. For the first time in the treatment of allergic conjunctivitis, DEXTENZA™ may provide full-season ocular itching relief in a single dose.

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

×
×

This PDF is available to Subscribers Only

Sign in or purchase a subscription to access this content. ×

You must be signed into an individual account to use this feature.

×