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FDA approves Lotemax SM for postoperative pain, inflammation
The FDA has approved Lotemax SM for the treatment of postoperative inflammation and pain following ocular surgery, Bausch + Lomb announced in a press release.
Lotemax SM (loteprednol etabonate ophthalmic gel 0.38%) delivers a submicron particle size that dissolves faster in tears than Lotemax Gel (loteprednol etabonate ophthalmic gel 0.5%) and provides double the penetration to the aqueous humor, the release said.
“With the FDA approval of Lotemax SM, physicians can now prescribe to their patients our most advanced loteprednol etabonate formulation to date, indicated for the treatment of postoperative inflammation and pain following ocular surgery,” Joe Gordon, Bausch + Lomb U.S. president, said in a Bausch Health press release. “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.”
The company plans to have Lotemax SM available by April, he said.
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Lotemax SM is the latest iteration in the 20-year history of loteprednol etabonate formulations. The “SM” stands for “submicron” — the loteprednol molecule is only 0.6 µm, ie, in the nanometer range. This technology allows the molecule to adhere to the ocular surface and then penetrate key ocular tissues. It also allows for great efficacy at the lowest concentration of loteprednol and BAK that is available on the market.