Inspire Pharmaceuticals Inc announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval to market diquafosol tetrasodium (INS365) eye drops in a 2% preservative-free solution. Diquafosol represents a new approach to the treatment of dry eye. By stimulating P2Y2 receptors located on the ocular surface and inner lining of the eyelid, diquafosol enhances the secretion of water, salt, mucin and lipids -- key components of natural tears. This increase in the major components of the tear film is believed to result in improved tear volume and tear composition.
The diquafosol NDA submission includes data from one Phase II and two Phase III studies involving over 1,200 dry eye patients. Key data from the studies will be presented at the European Association for Vision and Eye Research (EVER) meeting in Alicante, Spain in October 2003.
"This NDA, Inspire's first, is a major achievement and is the result of nearly six years of focused and dedicated effort on the part of our employees, with valuable support from our partners and guidance from the FDA," stated Christy L. Shaffer, CEO of Inspire. "This milestone marks an important transition for our business as we begin building commercial capabilities."
The NDA submission triggers a milestone payment from Inspire's partner Allergan.
The FDA customarily accepts or refuses to file NDAs and designates review status within 60 days of submission.