2 August 2018 - - US-based biopharmaceutical company Ocular Therapeutix, Inc. (NASDAQ: OCUL) has received acknowledgement from the US Food and Drug Administration that the New Drug Application for Dextenza has been received, the company said.

Dextenza (dexamethasone insert) 0.4mg is Ocular Therapeutix's lead product candidate for the treatment of ocular pain following ophthalmic surgery. The FDA considers the NDA resubmission as a class 2 response to its July 2017 Complete Response Letter with a PDUFA (Prescription Drug User Fee Act) target date of December 28, 2018 for the completion of the FDA's review of the Dextenza NDA.

Dextenza 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, Dextenza is intended to resorb and exit the nasolacrimal system without the need for removal. Dextenza has completed Phase 3 evaluation for the treatment of ocular pain and inflammation following ophthalmic surgery.

Upon approval for pain, the company intends to submit an NDA supplement for the treatment of inflammation following ocular surgery.

Dextenza is also in Phase 3 clinical development for allergic conjunctivitis.

Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology.

Ocular Therapeutix has resubmitted an NDA for post-surgical pain for its lead product candidate, Dextenza (dexamethasone insert), which has completed Phase 3 clinical development for the treatment of ocular pain and inflammation following ophthalmic surgery.

OTX-TP (travoprost insert) is in Phase 3 clinical development for the reduction of intraocular pressure in patients with primary open-angle glaucoma and ocular hypertension.

The company's earlier stage assets include OTX-TIC, an extended-delivery travoprost intracameral implant for the reduction of intraocular pressure in patients with glaucoma and ocular hypertension, as well as sustained release intravitreal implants for the treatment of retinal diseases.

These intravitreal implants include OTX-TKI, a tyrosine kinase inhibitor, and, in collaboration with Regeneron, OTX-IVT, an extended-delivery protein-based anti-vascular endothelial growth factor trap, both for the treatment of retinal diseases.

Ocular Therapeutix's first product, ReSure Sealant, is FDA-approved to seal corneal incisions following cataract surgery.