Phase III ReOpen1 trial of Xhance meets co-primary endpoints in chronic sinusitis.- Optinose

A statistically significant improvement was demonstrated in patients who were treated with the fluticasone propionate Exhalation Delivery System in the ReOpen1 clinical trial compared to patients receiving an Exhalation Delivery System placebo as measured by both primary endpoints: first, a composite symptom score (comprising nasal congestion, facial pain or pressure, and nasal discharge) measured at week 4 and second, an objective measure of disease in the sinus cavities at week 24 (measured by average percent of the opacified volume on CT scan, summed across all of the ethmoid and maxillary sinuses).

The Company expects top-line results from ReOpen2, the second of its two phase III trials for Xhance in chronic sinusitis, in the second quarter of 2022. The safety profile and tolerability of Xhance in this trial were generally consistent with its currently labelled 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 this trial will be submitted for publication in a peer-reviewed journal and for presentation at future medical meetings.