FDA Approves Lotemax SM for Ocular Surgery Pain, Inflammation

Troy Brown, RN


February 25, 2019

The US Food and Drug Administration (FDA) has approved a new formulation of loteprednol etabonate ophthalmic gel (Lotemax SM, Bausch + Lomb) 0.38% for postoperative inflammation and pain associated with ocular surgery.

"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, US president of Bausch + Lomb, said in a company news release.

"Compared to Lotemax Gel (loteprednol etabonate ophthalmic gel) 0.5%, Lotemax SM delivers a submicron particle size for faster drug dissolution in tears. Lotemax SM also provides two times greater penetration to the aqueous humor compared to Lotemax Gel," the company explained.

The new formulation uses submicron particles to facilitate adherence to the ocular surface and penetration of the aqueous humor and important ocular tissues. As with Lotemax Gel 0.5%, the SM formulation contains the moisturizing ingredients glycerin and propylene glycol, has a pH comparable to that of human tears, and has the lowest percentage of preservatives in a loteprednol etabonate formulation, according to the news release.

The FDA's approval follows consideration of data from two randomized, multicenter, double-masked, parallel-group, vehicle-controlled studies that included 742 patients with postoperative inflammation associated with cataract surgery.

"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," Marguerite McDonald, MD, FACS, ophthalmologist and clinical professor of ophthalmology, New York University School of Medicine, New York City, said in the news release.

"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," she said.

Patients received the SM formulation or vehicle three times daily to the affected eye starting the day after surgery. Twice as many patients who received the treatment drug experienced complete resolution of inflammation at day 8 compared with those who received vehicle (30% vs 15%; P < .0001). Patients treated with the study drug were significantly more likely to be pain free at day 8 (74% vs 49%; P < .0001) and day 3 (secondary endpoint; 72% vs 50%; P < .0001) compared with those in the group that received vehicle.

Treatment-emergent adverse drug reactions occurred in no more than 1% of patients who received the drug three times daily compared with those who received vehicle.

The company expects loteprednol etabonate ophthalmic gel to be available in the SM formulation by April 2019.

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