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FDA Approves Ophthalmic Products, Lotemax And Alrex ROCHESTER, NY and ISELIN, NJ -- March 10, 1998 -- The United States Food and Drug Administration has granted Bausch & Lomb Pharmaceuticals and Pharmos Corp. marketing approval to manufacture and market two new ophthalmic products, Lotemax(TM) (loteprednol etabonate ophthalmic suspension 0.5%) and Alrex(TM) (loteprednol etabonate ophthalmic suspension 0.2%). Lotemax is a topical, site-specific steroid that will be used to treat post-operative eye inflammation such as that experienced following cataract surgery. The new prescription eye drop will also be used for various other inflammatory eye conditions. The novel chemical structure of Lotemax allows it to be predictably transformed by enzymes in the eye to an inactive metabolite, and increases its safety profile. The excellent safety profile of Lotemax was demonstrated in clinical trials by a low incidence of increased intraocular pressure, a significant side effect of ophthalmic steroid use. In addition to the excellent safety profile of Lotemax, the product will have the broadest range of indications of any ophthalmic steroid on the market. Alrex is a specially developed formula of loteprednol etabonate that will be used in the treatment of ophthalmic allergies. Alrex is indicated for the treatment of seasonal allergic conjunctivitis, an inflammation of the eye usually caused by pollens. Seasonal allergic conjunctivitis produces itching, tearing, redness and swelling in the conjunctiva -- the membrane that covers the inside of the eyelid and the white part of the eye. The regulatory approvals for Lotemax and Alrex are the first two of three sought for the Bausch & Lomb/Pharmos line of ophthalmic products containing loteprednol etabonate. The third product, which combines the active ingredient loteprednol etabonate with an anti-infective agent, is in development. E-mail this page to a friend or colleague! To print, use this version