Inspire Gets FDA Nod
An agreement between the U.S. Food and Drug Administration and Durham-based Inspire Pharmaceuticals has opened the door to the firm's fifth attempt to prove its Prolacria dry-eye treatment should be approved for marketing.
After lengthy negotiations with the regulators, Inspire has begun a Phase III test of Prolacria in 450 patients in United States and Canada to determine if its benefits outweigh any downsides.
Inspire is developing treatments for various respiratory and eye diseases caused by malfunctions in hydration of the body's mucosal tissues.
The firm already markets two eye products developed in collaboration with Allergan: Elestat, for allergic conjunctivitis, and Restasis, for dry eye disease. Another marketed product, AzaSite, licensed from InSite Vision, treats bacterial conjunctivitis.
Other product candidates include treatments for cystic fibrosis, allergic rhinitis, and glaucoma.
Meanwhile, the firm has announced that President and CEO Christy Shaffer, Ph.D., will give a presentation at the BIO CEO & Investor Conference next Tuesday in New York City. A Web cast of the presentation will be available on Inspire's web site.