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Ocular Therapeutix™ Announces First Patient Dosed in Phase 3 Clinical Trial of DEXTENZA® for the Treatment of Post-Surgical Ocular Inflammation and Pain in Children
BEDFORD, Mass.--(BUSINESS WIRE)-- Ocular Therapeutix™, Inc. (NASDAQ: OCUL), a biopharmaceutical company focused on the formulation, development, and
About this update from Ocular Therapeutix, Inc.
[{"type":"text","content":" 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 that it has dosed the first patients in a Phase 3 clinical trial of DEXTENZA® (dexamethasone ophthalmic insert) 0.4 mg for the treatment of post-surgical ocular inflammation and pain in children following cataract surgery.\n\n\n“We are pleased to announce the start of a new clinical trial designed to evaluate the use of DEXTENZA for the treatment of post-surgical inflammation and pain in children undergoing cataract surgery,” said Michael Goldstein, MD, MBA, Chief Medical Officer. “Performing cataract surgery in children represents a different set of surgical and technical challenges. One area critical to surgical outcomes is postoperative medication non-compliance. It can be very challenging to successfully administer topical eye drops to children particularly when they have recently had surgery. If approved for pediatric use, DEXTENZA could provide pediatric ophthalmic surgeons with an interesting product to use to help their patients.”\n\n\nThe Phase 3 clinical trial is a U.S.-based, randomized, multicenter clinical trial that intends to enroll approximately 60 subjects between the ages of 0-3 years. The clinical trial is designed to evaluate the safety and biological activity of DEXTENZA compared to an active control, prednisolone acetate suspension eye drops, for the treatment of postoperative inflammation and pain following ocular surgery for pediatric cataract. This planned clinical trial is a post-approval requirement of the U.S. Food and Drug Administration (FDA), in accordance with the Pediatric Research Equity Act of 2003, in connection with the FDA’s prior approval of DEXTENZA for the treatment of inflammation and pain following ophthalmic surgery in adults.\n\n\nAbout DEXTENZA\n\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 ...