Allergan, Inc. announced that the US 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.
ZYMAXID contains 0.5% gatifloxacin, a well-established fluoroquinolone, and is formulated with the preservative benzalkonium chloride (BAK). In clinical studies, ZYMAXID ophthalmic solution demonstrated a statistically superior eradication of bacterial conjunctivitis – approximately 90 percent (301/333) versus 70 percent (228/325) for vehicle (the recommended dosage is one drop every two hours in the affected eye(s) while awake, up to eight times on Day one and then two to four times daily while awake on Days two through seven).1 ZYMAXID is efficacious against a broad spectrum of gram-positive and gram-negative pathogens.
“As pathogens continue to evolve and become more resistant to antibiotics, it is important to develop more potent formulations of anti-infective drugs,” said Scott Whitcup, M.D., Allergan’s Executive Vice President, Research and Development and Chief Scientific Officer. “Allergan has a history of innovation in ocular anti-infective drugs dating back to OCUFLOX(R) ophthalmic solution in the early 1990s, and we are pleased to offer a new option to eye care professionals and their patients.”
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(TM) 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.
ZYMAXID is expected to be available to physicians and patients in the United States in June 2010.
Date: May 19, 2010
Filed Under: Drug Discovery