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Executive Summary

ALCON's OPHTHALMIC STEROID/ANTIBIOTIC TOBRADEX is a "significant improvement in combination therapy," the firm maintains in a recent introductory trade letter. TobraDex, a combination of tobramycin and dexamethasone, was approved by FDA on Aug. 19 after approximately three-and-a-half years of review. Alcon already has a leading product in the steroid/antibiotic ophthalmic market, Maxitrol (neomycin sulfate, polymyxin B sulfate and dexamethasone). Alcon claims that Maxitrol is the leader in the $ 30 mil. category. In a promotional fact sheet on TobraDex, Alcon asserts that the product has "unsurpassed antibiotic spectrum, . . . optimum anti-inflammatory activity [and is] less sensitizing than combinations with neomycin." Alcon began shipping TobraDex Aug. 24. The firm's price to wholesalers is $ 9 for a 5 ml dispenser and $ 108 for a dozen dispensers. Approved labeling states that "TobraDex opthalmic suspension is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists." Ocular steriods, labeling continues, "are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns, or penetration of foreign bodies." Alcon also markets tobramycin as a single ingredient product, under the brand name Tobrex, for external eye infections. The firm licenses rights to ophthalmic uses of the antibiotic from Lilly. Alcon noted that the tobramycin patent expires next year and that the firm is exploring options for ensuring exclusivity of the new combination product.

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