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Phase 3 clinical trial enrollment begins for ocular allergy drug
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Enrollment is underway for a second phase 3 clinical trial of Dextenza sustained release dexamethasone for treatment of allergic conjunctivitis, according to a press release from Ocular Therapeutix.
The prospective, randomized, double-masked, vehicle controlled, multicenter trial will evaluate safety and efficacy of the 0.4 mg bioresorbable intracanalicular depot in patients with chronic symptoms of allergic conjunctivitis.
The company reported topline results of its first phase 3 clinical trial in October in which both ocular itching and conjunctival redness were each a primary endpoint. For this second phase 3 trial, the only primary endpoint is for ocular itching, which will be assessed at day 7 after insertion of the drug.
“The start of another phase 3 clinical trial for Dextenza demonstrates our commitment to applying our proprietary hydrogel platform to additional indications where patients can benefit from sustained-release therapies,” Amar Sawhney, PhD, president, CEO and chairman of Ocular Therapeutix, said in the release.
Pending results of this phase 3 trial and approval by the FDA of a new drug application for Dextenza for treatment of postsurgical ocular pain, Ocular Therapeutix intends to submit a new drug application supplement to include the indication of ocular itching associated with allergic conjunctivitis, according to the release.