Business
Ocular Therapeutix™ Announces Submission to the FDA of a Supplemental New Drug Application for DEXTENZA® (dexamethasone ophthalmic insert) for the Treatment of Ocular Itching Associated with Allergic Conjunctivitis
PDUFA Target Action Date Anticipated for October 2021 BEDFORD, Mass.--(BUSINESS WIRE)-- Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company
About this update from Ocular Therapeutix, Inc.
[{"type":"text","content":"\nPDUFA Target Action Date Anticipated for 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 submission of the supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for DEXTENZA® (dexamethasone ophthalmic insert) 0.4 mg for intracanalicular use. 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 share the allergic conjunctivitis data with the FDA and feel this sNDA supports an expanded label. If approved, the sNDA would reflect the second expansion of the DEXTENZA label and would include the first indication for DEXTENZA treated primarily in the ophthalmology office setting,” said Antony Mattessich, President and Chief Executive Officer of Ocular Therapeutix. “It is estimated that up to 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 and significant potential market for DEXTENZA beyond its current use in the surgical setting. From a business perspective, ocular itching associated with allergic conjunctivitis is our first potential indication in the treatment of an ocular surface disease, paving the way for our two Phase 2 clinical programs in the treatment of dry-eye disease.”\n\nThe efficacy of DEXTENZA for the treatment of ocular itching was evaluated in four vehicle-controlled clinical trials for subjects with a positive history of ocular allergies and positive skin test reaction to perennial and seasonal allergens (n=323). The sNDA offers data that Ocular believes supports that DEXTENZA demonstrated superiority to placebo vehicle for the treatment of ocular itching due to allergic conjunctivitis as evidenced by statistically significant differences in a pooled analysis of three well controlled Phase 3 clinical trials as well as in the Phase 2 clinical trial. At the primary endpoint for the pooled analysis of the three Phase 3 clinical trials (Day 8), ocular itching scores favored DEXTENZA tre...