BRIDGEWATER, NJ — Bausch + Lomb announced that the U.S. Food and Drug Administration has approved Lotemax SM 0.38%, a gel formulation for the treatment of postoperative inflammation and pain following ocular surgery.
Compared to Lotemax Gel 0.5%, Lotemax SM (loteprednol etabonate ophthalmic gel) delivers a submicron particle size for faster drug dissolution in tears, according to a press release from the company. Lotemax SM also provides two times greater penetration to the aqueous humor compared to Lotemax Gel.
“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,” said Joe Gordon, U.S. president, Bausch + Lomb.
“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. We are planning to make LOTEMAX SM available as a new treatment option for patients by April 2019.”
“Patients undergoing ocular surgery, including cataract surgery, often experience inflammation that needs to be treated. This inflammation can be painful and result in serious complications,” said Dr. Marguerite McDonald, ophthalmologist and clinical professor of ophthalmology, New York University School of Medicine.
“In two clinical trials, LOTEMAX SM was significantly more effective than vehicle in completely resolving ocular inflammation and pain following cataract surgery, one of the most common operations performed in the United States.
“LOTEMAX SM provides proven efficacy, efficient penetration, and less frequent dosing compared to LOTEMAX GEL, and the tolerability profile that we have come to expect from the loteprednol etabonate molecule. Together these factors support LOTEMAX SM as an important new option for many of my patients who require treatment for inflammation and pain following ocular surgery.”