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Loteprednol/tobramycin combo receives ‘approvable’ letter

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ISELIN, N.J. — A combination anti-inflammatory and antibiotic drug received an “approvable” letter from U.S. regulators, the drug’s developer said in a press release.

The combination drug, ZyLet (loteprednol etabonate, tobramycin ophthalmic suspension, Pharmos) is “aimed at treating patients with steroid-responsive inflammatory ocular conditions who have or are at risk of developing superficial bacterial ocular infections,” according to the press release from Pharmos Corp.

The company noted that the Food and Drug Administration issued the “approvable” letter to Bausch & Lomb, which acquired the rights to market the product.

B&L announced its receipt of the letter last week in a regulatory filing, according to Pharmos. B&L indicated it is targeting approval of the drug for some time in the second half of 2004, Pharmos added.

B&L acquired the marketing rights to loteprednol from Pharmos in 2001.