InSite Vision Files New Drug Submission with Health Canada for Topical Eye Antibiotic - AzaSite
Alameda, CA - InSite Vision Incorporated announced recently that it has filed a New Drug Submission (NDS) with Health Canada seeking regulatory approval to market the topical ocular antibiotic AzaSite (azithromycin ophthalmic solution) 1% for the treatment of bacterial conjunctivitis (pink eye) in Canada.
AzaSite was approved for bacterial conjunctivitis treatment by the United States Food and Drug Administration (FDA) in April 2007, and was commercially launched in the United States in August 2007 by Inspire Pharmaceuticals, Inc., a biopharmaceutical company based in Durham, North Carolina and AzaSite's exclusive licensee in the United States and Canada.
"Canada is the first country outside the United States where InSite has filed for the regulatory approval of AzaSite," said S. Kumar Chandrasekaran, Ph.D., Chief Executive Officer and President. "This second filing is an important step in AzaSite worldwide commercialization, and will enable our partner Inspire to expand sales of AzaSite beyond the borders of the United States," Chandrasekaran concluded.
InSite has granted exclusive rights to Inspire to commercialize AzaSite for the treatment of ocular infections in the United States and Canada in exchange for milestone payments and royalties for products sold in both countries.
About AzaSite
AzaSite contains the drug azithromycin, a broad-spectrum antibiotic formulated with InSite's proprietary sustained drug delivery technology (DuraSite) as eye drops. This is the first time azithromycin has been formulated successfully for use in the eye. AzaSite offers a reduced dosing frequency as compared to currently available eye drops in the United States for the treatment of bacterial conjunctivitis and has a favorable safety and efficacy profile.
About DuraSite
InSite's DuraSite sustained delivery technology is a patented synthetic polymer-based formulation designed to extend the residence time of a drug relative to conventional topical therapies. It enables topical delivery of a solution, gel or suspension and can be customized for delivering a wide variety of potential drug candidates.
SOURCE: InSite Vision Incorporated