Supplemental NDA accepted for Dextenza inflammation indication
The FDA has accepted a supplemental new drug application for Dextenza for the treatment of ocular inflammation following ophthalmic surgery, Ocular Therapeutix announced.
Dextenza (dexamethasone ophthalmic insert 0.4 mg) is the first FDA-approved intracanalicular insert to treat post-surgical ocular pain.
The supplemental NDA is supported by the two phase 3 clinical trials used to obtain the pain approval, and safety and efficacy data from a third prospective, multicenter, randomized phase 3 clinical trial in cataract surgery patients, according to a press release.
A PDUFA date has been set for Nov. 10.