Allergan, Inc. announced that the United States Food and Drug Administration (FDA) has approved Zymaxid (gatifloxacin ophthalmic solution) 0.5%, a topical fluoroquinolone anti-infective indicated 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, Streptococcus pneumonia.
Zymaxid is now the highest concentration gatifloxacin ophthalmic solution on the market in the United States.
As reported by the company, the efficacy of Zymaxid ophthalmic solution was assessed in two multicenter, double-masked, randomized dual-arm comparison studies involving 1,437 patients receiving either Zymaxid or vehicle. In the clinical studies, the efficacy of Zymaxid 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 six, complete clearance of conjunctival hyperaemia and conjunctival discharge was achieved in 58 percent of patients (193/333) treated with Zymaxid ophthalmic solution compared to 45 percent (148/325) in the vehicle group.