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New monotherapy steroid ointment available
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MADISON, N.J. — Bausch + Lomb has launched a preservative-free topical ophthalmic steroid formulation for use in the treatment of postoperative inflammation and pain after ocular surgery, according to a company news release.
Lotemax ointment (loteprednol etabonate ophthalmic ointment 0.5%) is the first monotherapy steroid ointment brought to the U.S. market in more than two decades, according to the release. It is currently available only within the U.S.
In two 4-week clinical trials, loteprednol etabonate ophthalmic ointment was compared with a vehicle control for treatment of pain and inflammation after cataract surgery. The studies showed that loteprednol etabonate provided statistically significant resolution of anterior chamber cells and flare at 8 days postop, according to the release.
The trials were both phase 3, randomized, multicenter, double-masked parallel-group comparative studies that included 805 patients, according to the release.
The most common adverse event after use of loteprednol etabonate was anterior chamber inflammation, which was reported in approximately one-fourth of patients, the release said.