Optinose announced the U.S. Food and Drug Administration (FDA) accepted for review its supplemental new drug application (sNDA) requesting approval of XHANCE as a treatment for chronic rhinosinusitis. XHANCE® (fluticasone propionate) nasal spray is a drug-device combination product that combines the most widely used nasal anti-inflammatory drug with the innovative Exhalation Delivery System™ (EDS™). The EDS is designed to uniquely deliver drug high and deep into difficult-to-access sinuses and sinonasal drainage tracts.

The sNDA submission is based on data from the two Phase 3 clinical trials in patients with chronic sinusitis from the ReOpen Program and has been assigned a Prescription Drug User Fee Act (PDUFA) target goal date of December 16, 2023.