Ocular Therapeutix (NSDQ:OCUL) said today that the FDA has accepted a new supplemental New Drug Application for its Dextenza, an ocular insert designed to release dexamethasone to relieve pain following ophthalmic surgery.
The Bedford, Mass.-based company’s device is designed to deliver drugs for up to 30 days following treatment in a physician’s office. Ocular Therapeutix is positioning its product as a way to eliminate the current standard of care for post-surgical pain – topical steroid eye drops.
With the new application, Ocular Therapeutix is seeking an indication for treating ocular inflammation following ophthalmic surgery. The company added that the FDA has set a Prescription Drug User Fee Act target action date of November 10 for its review of the application.
The company said that the application was supported by data from two Phase 3 clinical trials and a third prospective, multicenter, randomized, controlled Phase 3 clinical trial, according to a press release.
In January, Ocular Therapeutix submitted the supplemental NDA to the FDA for its Dextenza insert.