Related Experiment Videos
Diquafosol tetrasodium. Inspire/Allergan/Santen
1Department of Physiology and Cellular Biophysics, College of Physicians and Surgeons, Columbia University, 630 West 168th Street, New York, NY 10032, USA. jf20@columbia.edu
Current Opinion in Investigational Drugs (London, England : 2000)
|February 5, 2004
Summary
Inspire is developing diquafosol tetrasodium (INS-365) eye drops for dry eye disease. The U.S. Food and Drug Administration (FDA) granted Priority Review status, with a decision expected in December 2003.
Area of Science:
- Ophthalmology
- Pharmacology
Background:
- Dry eye disease is a prevalent condition affecting millions worldwide.
- Current treatments for dry eye disease have limitations, necessitating novel therapeutic approaches.
Purpose of the Study:
- To evaluate the efficacy and safety of diquafosol tetrasodium (INS-365) eye drops for treating dry eye disease.
- To support the New Drug Application (NDA) submission to the FDA for INS-365.
Main Methods:
- Diquafosol tetrasodium (INS-365) is a novel, second-generation uridine nucleotide analog and P2Y2 receptor agonist.
- The drug is formulated as an eye drop for topical ocular administration.
Main Results:
- Inspire submitted an NDA for INS-365 in June 2003.
- The FDA granted Priority Review status in July 2003, indicating potential for expedited review.
Conclusions:
- FDA action on the NDA for INS-365 is anticipated in December 2003.
- A potential launch for INS-365 in the first half of 2004 is projected.