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Ocular Therapeutix begins Dextenza trial for allergic conjunctivitis
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The first patient has been dosed in a phase 3 clinical trial of Dextenza for the treatment of allergic conjunctivitis, Ocular Therapeutix announced in a press release.
The multicenter, randomized, double-masked, placebo-controlled trial will include 80 subjects and evaluate the safety and efficacy of Dextenza (dexamethasone ophthalmic insert 0.4 mg) compared with a placebo vehicle punctum plug. It will assess the effect of Dextenza on allergic reactions using a series of successive allergen challenges over 30 days, the release said.
“We believe Dextenza has the potential to replace the current standard of care eye drops with a one-time, long-acting, seasonal therapy for the treatment of [allergic conjunctivitis],” Antony Mattessich, Ocular Therapeutix president and CEO, said in the release. “With the start of this phase 3 trial, following the recent approval of Dextenza in the U.S. by the Food and Drug Administration for the treatment of ocular inflammation and pain following ocular surgery, we are clearly focused on demonstrating Dextenza’s potential as a platform product for Ocular Therapeutix both in the surgical and outpatient settings.”
Topline data from the trial are expected in the first half of 2020.