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ALCON LABS ALOMIDE (LODOXAMIDE TROMETHAMINE 1%) APPROVED SEPT. 23

Executive Summary

ALCON LABS ALOMIDE (LODOXAMIDE TROMETHAMINE 1%) APPROVED SEPT. 23 by FDA for "treatment of the ocular disorders referred to by the terms vernal keratoconjunctivitis, vernal conjunctivitis and vernal keratitis." The ophthalmic solution was designated a "1S" drug by FDA, indicating a new molecular entity given a standard, non-priority review. Alomide is designated an orphan drug for the indication. Lodoxamide is the second ophthalmic mast cell stabilizer approved in the U.S. for treatment of vernal keratoconjunctivitis (a seasonal allergic swelling of the eye) after Fisons' Opticrom (cromolyn sodium). Corticosteroids are also used for the condition. Opticrom has not been available in the U.S. since July 1990 because of manufacturing compliance problems at Fisons' U.K. facilities. An NDA is pending for an ophthalmic version of the cromolyn analog nedocromil, which Fisons and Allergan will copromote. Under a February agreement, Allergan will also copromote Opticrom when it is reintroduced in the U.S. ("The Pink Sheet" Feb. 8, T&G-4). "Lodoxamide tromethamine is a mast cell stabilizer that inhibits the in vivo Type I immediate hypersensitivity reaction," labeling states. "Lodoxamide has no intrinsic vasoconstrictor, anti histaminic, cyclo-oxygenase inhibition or other anti- inflammatory activity." In clinical trials of Alomide, "the most frequently reported ocular adverse experiences were transient burning, stinging, or discomfort upon instillation, which occurred in approximately 15% of the subjects," labeling states. "Other ocular events occurring in 1% to 5% of the subjects included ocular itching/pruritis, blurred vision, dry eye, tearing/discharge, hyperemia, crystalline deposits and foreign body sensation," labeling states. Opticrom labeling suggests a similar side-effect profile. Alomide labeling recommends the application of one to two drops four times daily in adults and children over two years old for up to three months. Opticrom is labeled for use in adults and children over the age of four with dosing of one to two drops four to six times daily. Alomide will be supplied in 2.5, 5, 10 and 15 mL Drop-Tainer dispensers, labeling states. FDA's approval letter for Alomide cautions Alcon against "suggestions or representations that this product is safe and effective in the treatment of allergic conjunctivitis or giant papillary con junctivitis. There are no data in this NDA from adequate and well-controlled trials that establish the safety and effectiveness of this product in the treatment of these diseases." Opticrom's indication for GPC was removed June 11 ("The Pink Sheet" Aug. 30, p. 6). Alcon submitted the NDA (20-191) for Alomide on June 4, 1991. The Nestle subsidiary licensed the rights to ophthalmic lodoxamide from Upjohn. The drug has been listed in the USAN Dictionary of Drug Names since 1978, but Upjohn apparently has abandoned development of oral forms of the drug.
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