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FDA Approves Gatifloxacin Ophthalmic Solution To Treat Bacterial Conjunctivitis

IRVINE, Calif., Mar 31, 2003 -- Allergan, Inc. (NYSE:AGN) announced today that the United States Food & Drug Administration (FDA) has approved ZYMAR(TM) (gatifloxacin ophthalmic solution) 0.3%, an anti-infective and the first fourth generation fluoroquinilone to enter the market. ZYMAR(TM) is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of bacteria.

A clear leader in the third generation category of fluoroquinolones with OCUFLOX(R) (ofloxacin ophthalmic solution), Allergan's ZYMAR(TM) will provide physicians with a powerful new product to treat ocular infection due to susceptible bacteria. ZYMAR(TM) is a highly efficacious fluoroquinolone with complete solubility, effective tissue penetration and low MIC 90s against a broad spectrum of organisms.

ZYMAR(TM) takes advantage of a unique mechanism of action to slow the development of bacterial resistance. Its molecular structure contains an 8-methoxy group that has been attributed to its dual mechanism of action, affording it an enhanced inhibition of both DNA-gyrase and Topoisomerase IV.

ZYMAR(TM) is currently expected to be available on the market within the next month.

The most frequently reported adverse events in the overall ZYMAR(TM) study population were conjunctival irritation, increased secretion of tears, inflammation of the cornea, and papillary conjunctivitis. These events occurred in approximately 5 to 10% of patients. Other reported reactions occurring in 1 to 4% of patients were swelling of the tissue surrounding the cornea, conjunctival hemorrhage, dry eye, eye discharge, eye irritation, eye pain, eyelid swelling, headache, red eye, reduced visual acuity and taste disturbance.

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