Posted by Michael Wonder on 04 Apr 2019
Ocular Therapeutix announces notification of FDA acceptance of supplemental new drug submission for Dextenza (dexamethasone ophthalmic insert) for the treatment of ocular inflammation following ophthalmic surgery
2 April 2019 - PDUFA target action date set for 10 November 2019
Ocular Therapeutix today announced the U.S. FDA has accepted for filing the supplemental new drug application (sNDA) for Dextenza (dexamethasone ophthalmic insert) to include the treatment of ocular inflammation following ophthalmic surgery in its label.
The sNDA application to include inflammation [following ophthalmic surgery] is supported by the two Phase 3 clinical trials used to obtain the pain approval and safety and efficacy data from a third prospective, multi-center, 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).
