The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for the Bausch + Lomb sub-micron loteprednol etabonate ophthalmic gel, 0.38%. It has 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 post-operative inflammation and pain following ocular surgery. This investigative product utilizes a novel submicron particle to help increase ocular penetration and residence time in anterior segment tissues.
“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,” said Tracy Valorie, senior vice president, U.S. Pharmaceuticals and Surgical, Bausch + Lomb. “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.”
See the full news release from Bausch + Lomb.