July 01, 2003
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Dry eye NDA filed with FDA
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Inspire Pharmaceuticals has submitted a new drug application to U.S. regulators for its newest dry eye treatment.
Diquafosol tetrasodium eye drops in a 2% preservative-free solution, formerly INS365, stimulates P2Y2 receptors on the ocular surface and inner lining of the eyelid to enhance secretion of water, salt, mucin and lipids, according to Inspire.
The submission includes data from phase 2 and phase 3 trials involving more than 1,200 patients. Key trial data is expected to be presented during the European Association for Vision and Eye Research meeting in October.
The NDA marks Inspire’s first regulatory submission.