Therapy Areas: Inflammatory Diseases
Ocular Therapeutix Resubmits Dexenza NDA to US FDA
5 July 2018 - - Bedford, Massachusetts-based ocular biopharmaceuticals specialist Ocular Therapeutix, Inc. (NASDAQ: OCUL) has resubmitted the new drug application (NDA) to the US FDA for its lead product candidate Dexenza (dexamethasone insert) 0.4mg, for the treatment of ocular pain following ophthalmic surgery, the company said.
The resubmission is intended to address manufacturing deficiencies cited by the FDA in the Agency's July 2017 complete response letter.
Dexenza is a corticosteroid intracanalicular insert placed through the punctum, a natural opening in the eye lid, into the canaliculus and is designed to deliver dexamethasone to the ocular surface for up to 30 days without preservatives.
Following treatment, Dexenza is intended to resorb and exit the nasolacrimal system without the need for removal.
Dexenza has completed phase 3 evaluation for the treatment of ocular pain and inflammation following ophthalmic surgery and is also in phase 3 clinical development for allergic conjunctivitis.
Ocular Therapeutix is focused on the development, manufacturing and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary hydrogel platform technology