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Ocular Therapeutix™ Announces FDA Acceptance of Supplemental New Drug Application for DEXTENZA® (dexamethasone ophthalmic insert) for the Treatment of Ocular Itching Associated with Allergic Conjunctivitis
PDUFA Action Date Set October 2021 BEDFORD, Mass.--(BUSINESS WIRE)-- Ocular Therapeutix, Inc. (Nasdaq: OCUL), a biopharmaceutical company focused on the
About this update from Ocular Therapeutix, Inc.
[{"type":"text","content":"\nPDUFA Action Date Set October 2021\n\n BEDFORD, Mass.--(BUSINESS WIRE)--\nOcular Therapeutix, Inc. (Nasdaq: OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced the supplemental New Drug Application (sNDA) for DEXTENZA® (dexamethasone ophthalmic insert) 0.4 mg for intracanalicular use has been accepted for review by the U.S. Food and Drug Administration (FDA). The FDA has set an action date under the Prescription Drug User Fee Act (PDUFA) of no later than October 18, 2021. If approved, this sNDA would include the treatment of ocular itching associated with allergic conjunctivitis as an additional approved indication of DEXTENZA.\n\n“We are excited to have received a PDUFA date from the FDA for our sNDA seeking to potentially broaden the label of DEXTENZA,” said Patricia Kitchen, Chief Operating Officer of Ocular Therapeutix. “An estimated 10 million1,2,3 people in the U.S. annually seek medical attention for the inflammatory response associated with allergic conjunctivitis caused by both seasonal and perennial allergens, representing a discrete market for DEXTENZA beyond its current use in the surgical setting. The use of topical steroids is an important part of the clinical armamentarium in the treatment of a patient with allergic conjunctivitis and if approved for this new proposed use, DEXTENZA could provide an office-based, physician administered, preservative-free method of steroid delivery that benefit patients with ocular itching associated with allergic conjunctivitis.”\n\nAbout DEXTENZA\n\nDEXTENZA is FDA approved for the treatment of ocular inflammation and pain following ophthalmic surgery. DEXTENZA is a corticosteroid intracanalicular insert placed in the punctum, a natural opening in the inner portion of the lower eyelid, and into the canaliculus and is designed to deliver dexamethasone to the ocular surface for up to 30 days without preservatives. DEXTENZA resorbs and exits the nasolacrimal system without the need for removal.\n\nThe safety of DEXTENZA was assessed in three Phase 3 clinical trials and a Phase 2 clinical trial evaluating DEXTENZA for the treatment of post-surgical inflammation and pain of the eye prior to its approval. Overall, 567 subjects were exposed to DEXTENZA in such c...