Posted by Michael Wonder on 02 Jul 2018
Ocular Therapeutix announces NDA resubmission of Dextenza
29 June 2018 - Ocular Therapeutix has announced the resubmission of the Company’s new drug application to the U.S. FDA for its lead product candidate Dextenza (dexamethasone insert) 0.4 mg, for the treatment of ocular pain following ophthalmic surgery.
The resubmission is intended to address manufacturing deficiencies cited by the FDA in the Agency’s July 2017 complete response letter.
