Ocular Therapeutix (OCUL) Announces FDA Acceptance of sNDA for DEXTENZA for Treatment of Ocular Itching Associated with Allergic Conjunctivitis
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Ocular 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.
“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.”
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