October 12, 2021
Ocular Therapeutix™ announces FDA approval of Supplemental New Drug Application (SNDA) for DEXTENZA® (dexamethasone ophthalmic insert) 0.4 mg for intracanalicular use for the treatment of ocular itching associated with allergic conjunctivitis
Approval represents the first primarily office-based indication for DEXTENZA.
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, announced on October 11 that the U.S. Food and Drug Administration (FDA) has approved its Supplemental New Drug Application (sNDA) to broaden the DEXTENZA label to add an additional indication for the treatment of ocular itching associated with allergic conjunctivitis. With the approval, DEXTENZA is the first, FDA-approved, physician-administered intracanalicular insert capable of delivering a preservative-free drug for the treatment of ocular itching associated with allergic conjunctivitis with a single administration for up to 30 days. DEXTENZA originally received FDA approval in November 2018 for the treatment of ocular pain following ophthalmic surgery, followed by an expansion of the label to also include the treatment of ocular inflammation following ophthalmic surgery in June 2019.
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, announced on October 11 that the U.S. Food and Drug Administration (FDA) has approved its Supplemental New Drug Application (sNDA) to broaden the DEXTENZA label to add an additional indication for the treatment of ocular itching associated with allergic conjunctivitis. With the approval, DEXTENZA is the first, FDA-approved, physician-administered intracanalicular insert capable of delivering a preservative-free drug for the treatment of ocular itching associated with allergic conjunctivitis with a single administration for up to 30 days. DEXTENZA originally received FDA approval in November 2018 for the treatment of ocular pain following ophthalmic surgery, followed by an expansion of the label to also include the treatment of ocular inflammation following ophthalmic surgery in June 2019.