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Ocular Therapeutix begins phase 3 trial of sustained-release corticosteroid
A phase 3 clinical program will investigate the safety and efficacy of sustained-release dexamethasone, a corticosteroid to treat inflammation and pain after cataract surgery, according to a press release from Ocular Therapeutix.
A one-time intracanalicular plug releases the steroid to the ocular surface for up to 30 days.
Two prospective, multicenter, randomized, parallel-arm, doubled-masked, vehicle-controlled studies are planned. In the first study, 240 clear corneal cataract surgery patients in the U.S. will be randomized to either dexamethasone treatment or a placebo plug. The primary endpoints include the absence of anterior chamber cells at day 14 and reduction of pain at day 8, the release said.
The second phase 3 trial will begin later this year.