Health Canada Approves Azithromycin Solution for Bacterial Conjunctivitis
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Health Canada Approves Azithromycin Solution for Bacterial Conjunctivitis

NEW YORK -- March 31, 2009 -- The Therapeutic Products Directorate (TPD) of Health Canada has approved azithromycin ophthalmic solution 1% (AzaSite) for the treatment of bacterial conjunctivitis in adults and children aged 1 year and older.

The approval was based on 2 international, placebo-controlled phase 3 trials with more than 1,400 patients with bacterial conjunctivitis. Azithromycin ophthalmic solution 1% was administered twice daily on the first 2 days, then once daily on days 3 to 5.

Results showed that azithromycin provided clinically and statistically significant improvements in clinical resolution of symptoms and bacterial eradication compared with placebo.

In addition, azithromycin solution was equivalent in clinical resolution and bacterial eradication when compared with tobramycin administered 4 times a day for 5 days.

SOURCE: InSite Vision

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