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Levofloxacin 1.5% approved

Issue: April 2004

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OSAKA, Japan — U.S. regulators have approved levofloxacin ophthalmic solution 1.5% (Iquix, Santen) for the treatment of both gram-positive and gram-negative bacterial corneal ulcers, said the manufacturer.

The approval was based on data from two randomized, double-masked multicenter trials of 280 patients with positive cultures.

In these trials, Iquix achieved clinical cure rates ranging between 73% and 87%, according to Santen. The most frequently reported adverse events were headache and a taste disturbance following instillation, which occurred in 8% to 10% of the study participants. The company said it expects to launch the drug later this year.