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BRIDGEWATER, N.J. — Bausch + Lomb announced it has begun distributing its LOTEMAX SM (loteprednol etabonate ophthalmic gel) 0.38% to U.S. pharmaceutical distributors. The company received final approval by the U.S. Food and Drug Administration (FDA) on Feb. 22, 2019. LOTEMAX SM is a new gel drop formulation of loteprednol etabonate, which was designed with novel SubMicron (SM) technology for efficient penetration to key ocular tissues at a low preservative (BAK) level and a pH close to human tears. It is indicated for the treatment of postoperative inflammation and pain following ocular surgery.
“LOTEMAX SM is the culmination of our clinical experience with the loteprednol etabonate compound for more than two decades. We are extremely proud to make this new treatment option available, our most advanced loteprednol etabonate formulation to date, to help our customers address the needs of their patients undergoing ocular surgery who experience postoperative inflammation and pain,” said Joe Gordon, U.S. president, Bausch + Lomb.
LOTEMAX SM delivers a submicron particle size and provides two times greater penetration to the aqueous humor as compared to LOTEMAX GEL (loteprednol etabonate ophthalmic gel) 0.5%. In addition, LOTEMAX SM was formulated with:
- moisturizing ingredients
- a pH close to that of human tears
- the lowest BAK preservative percentage in a loteprednol etabonate formulation (same percentage as LOTEMAX GEL [0.003% percent])
“I am excited to now offer my postoperative patients who experience pain and inflammation LOTEMAX SM, with its proven efficacy, efficient penetration, and less frequent dosing compared to LOTEMAX GEL,” said Dr. Marguerite McDonald, ophthalmologist and clinical professor of ophthalmology, New York University (NYU) School of Medicine. “In addition to the improved dosing compared to LOTEMAX GEL and the established efficacy, LOTEMAX SM offers a tolerability profile that I have come to rely on from the loteprednol etabonate molecule.”
