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Ocular Therapeutix begins clinical trial for sustained-release steroid
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Ocular Therapeutix Inc. announced commencement of its phase 3 clinical trial to investigate sustained-release dexamethasone, a corticosteroid to treat postoperative inflammation and pain following cataract surgery.
The drug is administered as a one-time, intracanalicular plug for release of the steroid to the ocular surface for up to 30 days, according to the press release.
Two prospective, multicenter, randomized, parallel-arm, doubled-masked, vehicle-controlled studies are planned, said the company. Following clear corneal cataract surgery, 240 U.S. patients will be randomized to either the dexamethasone treatment group or a placebo plug. According to the press release, primary results include the absence of anterior chamber cells at day 14 and reduction of pain at day 8.
“A single-dose corticosteroid can help manage issues of compliance by putting dosing into the hands of the physician and avoiding up to four drops per day and a tapering regimen that is confusing for the patient,” Amar Sawhney, PhD, president and CEO of Ocular Therapeutix, said in the release.