Inspire Pharmaceuticals, Inc. has submitted an amendment to its New Drug Application (NDA) filed in 2003 with the US FDA for approval to market diquafosol tetrasodium for the treatment of dry eye disease.

Diquafosol is a formulation of a dinucleotide discovered by Inspire scientists, which functions as an agonist at the P2Y2 receptor, stimulating the release of natural tear components targeting all three mechanisms of action involved in tear secretion - mucin, lipids and fluid.

Inspire previously filed an NDA with the FDA for diquafosol for the treatment of dry eye disease in June 2003 and received an approvable letter from the FDA in December 2003. Since the initial submission of the NDA, Inspire has completed two additional diquafosol Phase 3 clinical trials, trials 108 and 109, which included a total of more than 800 patients. The focus of the NDA amendment is on multiple analyses of ocular surface staining, including corneal staining and conjunctival staining, from Inspire's diquafosol clinical programme, release from Inspire said.

Gary N. Foulks, professor of Ophthalmology, Department of Ophthalmology and Vision Science, University of Louisville School of Medicine, and dry eye expert commented, "Dry eye disease is an extremely challenging disease to study and treat. Among the various ways to measure dry eye disease, ocular surface staining is well-recognized by clinicians as a hallmark of the disease."

In addition, Inspire and its partner, Allergan, Inc. have researched and submitted a trade name for diquafosol in the NDA amendment for FDA consideration.