InSite Vision wins Canadian approval for conjunctivitis drug

InSite Vision, a developer of new ocular pharmaceutical products, has reported that the Therapeutic Products Directorate of Health Canada has approved the company’s new drug submission for AzaSite 1% for the treatment of bacterial conjunctivitis in adults and children one year and older.

AzaSite is formulated with DuraSite, InSite Vision’s patented drug delivery vehicle that enhances the retention time of the antibiotic on the surface of the eye, offering the benefit of a less frequent and more convenient dosing regimen.

Canadian regulatory approval was based on two Phase III clinical trials of AzaSite which demonstrated that AzaSite was safe and effective.

AzaSite was approved for treatment of bacterial conjunctivitis by the FDA in April 2007, and commercially launched in August 2007 by Inspire Pharmaceuticals, a biopharmaceutical company and exclusive licensee of AzaSite in the US and Canada. Under the terms of the companies’ agreement, the new drug submission will transfer to Inspire Pharmaceuticals and Inspire will be responsible for marketing AzaSite in Canada.

Lou Drapeau, CEO of InSite Vision, said: Canadian approval of AzaSite is an important milestone for InSite, furthering our efforts to reach more patients with a product that is a clinically proven, safe and effective treatment for conjunctivitis and typically requires less than half the dosing of other ocular antibiotics.

We are focused on supporting our marketing partner, Inspire Pharmaceuticals, on the expansion of AzaSite sales and we look forward to working closely with them to capture additional value for the product throughout North America.