Optinose: 3-Month Extension of FDA Review Period for Application

 The application is based on phase 3 results from the ReOpen clinical trial program showing XHANCE significantly reduced symptoms and sinus opacification in participants with chronic rhinosinusitis

If approved, XHANCE is expected to be the first and only drug indicated for the treatment of chronic rhinosinusitis, a diagnosis which is assigned at approximately 10 million patient visits annually

https://www.globenewswire.com/news-release/2023/12/06/2791632/0/en/Optinose-Announces-3-Month-Extension-of-FDA-Review-Period-for-the-Supplemental-New-Drug-Application-for-XHANCE.html