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news.Allergan has received FDA approval for Zymaxid (gatifloxacin ophthalmic solution) 0.5%, a topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.
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Allergan claimed that Zymaxid is now the highest concentration gatifloxacin ophthalmic solution on the market in the US. Zymaxid contains 0.5% gatifloxacin, a topical fluoroquinolone, and is formulated with the preservative benzalkonium chloride. Zymaxid is expected to be available to physicians and patients in the US in June 2010.
In clinical studies, Zymaxid ophthalmic solution demonstrated a statistically superior eradication of bacterial conjunctivitis – approximately 90% (301/333) versus 70% (228/325) for vehicle. Zymaxid is efficacious against a broad spectrum of gram-positive and gram-negative pathogens.
Scott Whitcup, executive vice president of R&D and chief scientific officer of Allergan, said: “As pathogens continue to evolve and become more resistant to antibiotics, it is important to develop more potent formulations of anti-infective drugs.”