Lotemax SM Approved for Post-Operative Ocular Pain
February 25, 2019 – The U.S. FDA has approved Lotemax® SM (loteprednol etabonate ophthalmic gel) 0.38%, manufactured by Bausch + Lomb, to treat postoperative inflammation and pain following ocular surgery. The new product, which contains the same active ingredient as Lotemax® Gel 0.5%, uses a submicron particle size to improve drug dissolution and penetration.
Bausch + Lomb first introduced loteprednol etabonate products to the U.S. market more than 20 years ago. This latest formulation, in addition to the submicron particles, includes glycerin and propylene glycol as moisturizing agents, and has been formulated with a pH close to that of natural human tears. It is absorbed approximately twice as well as Lotemax Gel. Clinical studies demonstrated the new Lotemax SM’s effectiveness in relieving pain and inflammation after procedures such as cataract surgery. Thirty percent of patients achieved complete resolution of inflammation by the eighth day when treated with Lotemax SM. Seventy-two percent were pain-free by the third day.
A corticosteroid, Lotemax SM has a recommended dose of one drop in the affected eye three times daily. Treatment should begin the day following surgery, and continue for two weeks. The active ingredient was first approved in 1998.