Bausch + Lomb announced that the FDA has accepted the new drug application (NDA) for its sub-micron loteprednol etabonate ophthalmic gel 0.38%. The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of February 25, 2019. If approved, the product would be the lowest concentrated loteprednol ophthalmic corticosteroid indicated for the treatment of postoperative inflammation and pain following ocular surgery.
“The sub-micron loteprednol etabonate ophthalmic gel, 0.38% will offer eye care professionals and their patients a lower concentration formulation with less frequent dosing compared to currently available formulations of loteprednol,” Tracy Valorie, senior vice president, U.S. Pharmaceuticals and Surgical, Bausch + Lomb, said in a company news release. “We are committed to developing innovative ophthalmic treatment options to help serve the needs of patients and look forward to bringing this new product to market.”
This investigative product utilizes a novel submicron particle to help increase ocular penetration and residence time in anterior segment tissues.