First pediatric patients dosed in phase 3 Dextenza trial
Ocular Therapeutix has dosed the first patients in a phase 3 clinical trial of Dextenza for postoperative ocular inflammation and pain in children after cataract surgery, according to a press release.
The U.S.-based, randomized, multicenter trial will enroll about 60 patients between 0 and 3 years old and evaluate the safety and biological activity of Dextenza (dexamethasone ophthalmic insert 0.4 mg) against prednisolone acetate suspension eye drops.
“Performing cataract surgery in children represents a different set of surgical and technical challenges. One area critical to surgical outcomes is postoperative medication noncompliance. 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,” Michael Goldstein, MD, MBA, chief medical officer of Ocular Therapeutix, said in the release.
The trial is a post-approval requirement of the FDA in connection with the previous approval of Dextenza for the treatment of inflammation and pain after ophthalmic surgery in adults.