Ocular Therapeutix 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.
“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,” Michael Goldstein, MD, MBA, Chief Medical Officer, said in a company news release. “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.”
The 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 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.