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FDA Approves Gatifloxacin Ophthalmic Solution for Bacterial Conjunctivitis NEW YORK -- May 19, 2010 -- The US Food and Drug Administration (FDA) has approved gatifloxacin ophthalmic solution 0.5% (Zymaxid) for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms; Haemophilus influenzae, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus mitis group, Streptococcus oralis, and Streptococcus pneumonia. The efficacy of gatifloxacin ophthalmic solution was assessed in 2 multicentre, double-masked, randomised dual-arm comparison studies involving 1,437 patients receiving either gatifloxacin or vehicle. The efficacy of gatifloxacin was defined as complete clearance of conjunctival hyperaemia and conjunctival discharge, and when all bacterial species present at baseline were eradicated. Results of these studies demonstrated that at day 6, complete clearance of conjunctival hyperaemia and conjunctival discharge was achieved in 58% of patients (193/333) treated with gatifloxacin ophthalmic solution compared with 45%(148/325) in the vehicle group. SOURCE: Allergan, Inc. E-mail this page to a friend or colleague! To print, use this version