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Gatifloxacin receives FDA approval
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IRVINE, Calif. — The Food and Drug Administration has granted regulatory approval to Allergan for its anti-infective fluoroquinolone gatifloxacin, the company announced today.
Zymar (gatifloxacin ophthalmic solution) 0.3% has been approved for the treatment of bacterial conjunctivitis caused by susceptible strains of bacteria. A company statement notes Zymar’s molecular structure contains an 8-methoxy group, to which has been attributed the drug’s dual mechanism of action.
The most frequently reported adverse events in the overall Zymar study population were conjunctival irritation, increased secretion of tears, inflammation of the cornea and papillary conjunctivitis. These events occurred in about 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, Allergan noted.