Dosing begins in phase 2 trial of short-term dry eye treatment
The first patient has been dosed in a phase 2 clinical trial of OTX-DED for the short-term treatment of dry eye disease signs and symptoms, according to a press release from Ocular Therapeutix.
In the randomized, double-masked, vehicle-controlled trial, safety and efficacy of two formulations of OTX-DED (dexamethasone intracanalicular ophthalmic insert) will be assessed in about 150 patients with dry eye disease. Bulbar conjunctival hyperemia and corneal fluorescein staining as well as other secondary endpoints will be compared in study eyes vs. a matched vehicle control hydrogel insert.
“OTX-DED is a new, investigational, physician-administered, preservative-free intracanalicular insert designed to deliver either 0.2 mg or 0.3 mg doses of dexamethasone that has the potential to provide effective treatment with fewer [ocular surface] toxicities and adverse events,” Michael Goldstein, MD, MBA, president, ophthalmology, and chief medical officer of Ocular Therapeutix, said in the release.
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