Posted by Michael Wonder on 12 Jan 2019
Ocular Therapeutix submits supplemental new drug application for Dextenza (dexamethasone ophthalmic insert) for the treatment of ocular inflammation following ophthalmic surgery
10 January 2019 - Application expands the current Dextenza post-operative pain label as the first intra-canalicular insert for drug delivery.
Ocular Therapeutix today announced the submission of a supplemental new drug application to the U.S. FDA for Dextenza (dexamethasone ophthalmic insert).
The Company expects that the FDA review will be completed in the second half of 2019.
The application is supported by the two previous Phase 3 clinical trials and safety and efficacy data from an additional prospective, multi-centre, randomised, controlled Phase 3 clinical trial of Dextenza (n=438) in cataract surgery patients that demonstrated statistical significance compared to the vehicle control for the endpoints of absence of ocular pain (p<0.0001) and absence of inflammation (p<0.0001).
