The FDA has approved Allergan’s Zymaxid (gatifloxacin ophthalmic solution) 0.5%, a topical fluoroquinolone, for the treatment of bacterial conjunctivitis caused by susceptible organisms. Zymaxid is indicated against susceptible strains of Haemophilus influenzae, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus mitis group, Streptococcus oralis, Streptococcus pneumoniae. This approval was based on data from two multicenter, double-masked, randomized dual-arm comparison studies in 1,437 patients receiving Zymaxid or vehicle. Results demonstrated that at Day 6, complete clearance of conjunctival hyperaemia and conjunctival discharge was achieved in 58% of patients treated with Zymaxid compared to 45% of those who received vehicle.
Zymaxid is expected to be made available in June 2010.
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