Optinose's XHANCE Meets Primary Endpoints In Chronic Sinusitis Trial

Optinose Inc OPTN has announced positive data from the ReOpen1 Phase 3 trial of Xhance (fluticasone propionate) Exhalation Delivery System in chronic sinusitis.

• The trial met both of its co-primary endpoints - First, a composite symptom score (comprising nasal congestion, facial pain or pressure, and nasal discharge) and second, an objective measure of disease in the sinus cavities.
• A statistically significant improvement was demonstrated in patients with chronic sinusitis treated with the Xhance compared to patients receiving an Exhalation Delivery System placebo.
• The Company expects topline results from ReOpen2, the second of its two Phase 3 trials for Xhance in chronic sinusitis, in Q2 of 2022.
• The safety profile and tolerability of Xhance were generally consistent with its currently labeled safety profile. 
• Adverse events occurring at a rate of more than 3% with Xhance and more common than the Exhalation Delivery System placebo group were: epistaxis, nasopharyngitis, asthma, and cataract (nuclear and cortical).
• Detailed results from the trial will be submitted for publication in a peer-reviewed journal and presentation at future medical meetings.
• Price Action: OPTN shares are up 2.21% at $2.78 during the market session on the last check Monday.