Optinose Inc (NASDAQ: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.
