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FDA accepts NDA for loteprednol etabonate ophthalmic gel 0.38%

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A new drug application for Bausch + Lomb’s sub-micron loteprednol etabonate ophthalmic gel 0.38% has been accepted by the FDA, the company announced.

If approved, it would be the lowest concentrated loteprednol ophthalmic corticosteroid for the treatment of postoperative inflammation and pain after ocular surgery, according to a press release.

“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 of U.S. Pharmaceuticals and Surgical at Bausch + Lomb, said in the 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.”

The NDA has a Prescription Drug User Fee Act action date of Feb. 25, 2019.