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4/4/2003

Antiinfective Eye Solution Approved for Bacterial Conjunctivitis

Cheryl A. Thompson

Zymar, an ophthalmic solution containing 0.3 percent gatifloxacin, was approved by the Food and Drug Administration for the treatment of conjunctivitis caused by bacterial strains susceptible to the fluoroquinolone, Allergan Inc. announced March 31.

The company said it expects to have its new product available in pharmacies this month.

According to the company, the most frequently reported adverse reactions to gatifloxacin ophthalmic solution during the clinical studies were local irritation, increased secretion of tears, inflammation of the cornea, and the formation and enlargement of bumps on the eyelid. These reactions occurred in up to 10 percent of patients.

Allergan did not provide details on the product's recommended dosage or contraindications. The labeling for other fluoroquinolone-containing ophthalmic products states that they are not to be used in patients with a hypersensitivity to the antiinfective, other quinolones, or compounds in the formulation.

Update, 7 April 2003—According to the labeling for Zymar (PDF), released today by the Food and Drug Administration, the recommended instructions for using the ophthalmic product are as follows: on days 1 and 2, instill one drop every two hours, up to eight times daily, into the affected eye or eyes while the patient is awake; on days 3–7, instill one drop up to four times daily into the affected eye or eyes while the patient is awake. The ophthalmic solution contains the preservative benzalkonium chloride.