Inspire Pharmaceuticals Inc announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review for Inspire's New Drug Application (NDA) for diquafosol tetrasodium ophthalmic solution, for the treatment of dry eye. Priority Review is an FDA procedure designed to accelerate the review of potential products that address a significant unmet medical need. The designation of Priority Review sets the target date for initial FDA action at 6 months from the NDA submission date. The NDA submission date for diquafosol was June 27, 2003. Official notification from the FDA on filability of the NDA is expected in September, which is within the usual timeframe for such notification.
"We are pleased that the FDA has granted Priority Review for diquafosol and we have already begun an active dialogue with the FDA on various aspects of the submission," said Christy L. Shaffer, CEO of Inspire. "We are continuing our efforts toward building a commercial infrastructure to co-promote this potential new product with our partner, Allergan Inc. Given the possibility of accelerated action on the diquafosol NDA, we intend to have our sales force ready for a potential first quarter 2004 launch."
Dry eye is a painful, burning and irritating condition involving abnormalities and deficiencies in the tear film due to a variety of causes. It affects approximately 10 million North Americans and is one of the most frequent patient complaints reported to ophthalmologists and optometrists. The majority of dry eye patients rely on artificial tears to relieve symptoms. Allergan's Restasis is the first and only pharmacologically active prescription product approved for patients with chronic dry eye disease.