BEDFORD, MA– Ocular Therapeutix, a biopharmaceutical company focused on the development, manufacturing and commercialization of innovative therapies for diseases and conditions of the eye, said that the U.S. Food and Drug Administration has determined that it cannot approve the new drug application for DEXTENZA in its present form.
The drug is potentially developed for the treatment of ocular pain following ophthalmic surgery. .
“We are evaluating the FDA’s response and plan to work closely with the agency in an effort to satisfy the requirements related to the NDA (New Drug Application),” said Ocular Therapeutix President, Chief Executive Officer and Chairman, Amar Sawhney. “Importantly, there were no clinical issues identified in the CRL (Complete Response Letter) pertaining to efficacy or safety related to the post-surgical pain indication. We believe that DEXTENZA can be approved once these open manufacturing items are resolved.”
DEXTENZA is placed through the punctum, a natural opening in the eye lid, into the canaliculus and is designed to deliver dexamethasone without preservatives to the ocular surface for up to 30 days. Following treatment, DEXTENZA resorbs and exits the nasolacrimal system without need for removal, company said in a statement.
Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the development, manufacturing and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary hydrogel platform technology. Ocular Therapeutix’s lead product candidate, DEXTENZA™ (dexamethasone insert) 0.4 mg for intracanalicular use has completed Phase 3 clinical development for the treatment of ocular pain and inflammation following ophthalmic surgery.