New loteprednol formulation approved for postop inflammation, pain management

Bausch + Lomb’s new formulation of loteprednol etabonate, Lotemax SM 0.38%, has been cleared by the FDA for postoperative pain and inflammation.

Unlike its predecessor Lotemax Gel 0.5%, this new formulation uses a proprietary submicron (SM) technology that enables the drug to more quickly dissolve in tears, significantly improving its penetration to the aqueous humor. Lotemax SM contains the lowest concentration of preservative (0.003% BAK) among available loteprednol drops, with a pH comparable to human tears and the addition of glycerin and propylene glycol for moisturization.

“Lotemax SM provides proven efficacy, efficient penetration, and less frequent dosing than Lotemax Gel, and the tolerability profile that we have come to expect from the loteprednol etabonate molecule,” explains Marguerite McDonald, MD, FACS. “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.”

The FDA based their decision—which comes nearly 2 decades after Bausch + Lomb released their first formulation of loteprednol etabonate—on 2 randomized, multicenter, double-masked, parallel group, vehicle-controlled studies that comprised 742 patients with postop inflammation after cataract surgery. Compared with the vehicle arm, nearly twice as many patients who received 3 daily doses of Lotemax SM experienced complete inflammation resolution by day 8 (30% vs 15%; P<0.0001). More than 70% of study patients were also pain-free at day 3 and 8 while only half of controls were free of pain. Treatment-emergent adverse drug reactions occurred in no more than 1% of patients in the treatment group compared with controls.

According to the press release, the company expects Lotemax SM to be available April 2019.