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