Officials with the FDA have approved loteprednol etabonate ophthalmic gel 0.38% (Lotemax SM, Bausch + Lomb) for the treatment of postoperative inflammation and pain following ocular surgery.

Compared to loteprednol etabonate ophthalmic gel 0.5% (Lotemax Gel, Bausch + Lomb), the new formulation delivers a submicron particle size for faster drug dissolution in tears. The 0.38% formulation also provides 2 times greater penetration to the aqueous humor compared to 0.5%, according to Bausch + Lomb.   

In a statement, said Joe Gordon, US president, Bausch + Lomb, said the new FDA approval provides physicians with the ability prescribe to their patients the company’s most advanced loteprednol etabonate formulation to date. "Since Bausch + Lomb introduced the first formulation of loteprednol etabonate more than 20 years ago, we have continued to advance formulations that meet the changing needs of our patients,” Gordon said.

The new loteprednol etabonate ophthalmic gel formulation is expected to be available as a treatment option by April 2019.


Bausch + Lomb Announces FDA Approval Of LOTEMAX® SM (loteprednol Etabonate Ophthalmic Gel) 0.38% For The Treatment Of Postoperative Inflammation And Pain Following Ocular Surgery [news release]. Bridgewater, New Jersey; February 25, 2019: Bausch + Lomb. Accessed February 25, 2019.