(NASDAQ:OPTN) OPTINOSE INC. announced positive top line results from Phase 3 clinical study.

YARDLEY, Pa., June 13, 2022 (GLOBE NEWSWIRE) — Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today announced the statistically significant benefits of XHANCE in the ReOpen2 trial for both the symptoms co-primary endpoint and the CT scan co-primary endpoint. Significant improvement was demonstrated in patients with chronic sinusitis who did not have nasal polyps treated with both doses of XHANCE (fluticasone propionate) nasal spray with the Exhalation Delivery System in the ReOpen2 clinical trial compared to patients receiving a vehicle Exhalation Delivery System (placebo). The co-primary endpoints were a patient-reported composite symptom score (comprising nasal congestion, facial pain or pressure, and nasal discharge) measured at week 4 and an objective measure of disease in the sinus cavities at week 24 (measured by average of the percentages of opacified volume on CT scan across the ethmoid and maxillary sinuses).

ReOpen2 is a large, international, controlled trial, studying 222 patients with chronic sinusitis who did not also have nasal polyps. Currently there are no FDA-approved drug treatments for this large patient population, said Ramy Mahmoud, MD, MPH, President of Optinose. He went on to say, With top-line results showing that patients with chronic sinusitis experienced significant improvement in both symptoms and inflammation inside the sinuses, ReOpen2 confirms and builds on the positive results from ReOpen1 and, importantly, provides evidence supporting the effectiveness of XHANCE in the very large chronic sinu sitis population without nasal polyps. This program provides the first-ever body of controlled trial evidence we are aware of for a nasal medication to produce both improvement in symptoms and reduction of inflammation in the sinus cavities for patients suffering from chronic sinusitis regardless of the presence of nasal polyps. We believe these results are important to the tens of millions of people suffering from chronic sinus disease, so our team is working to quickly complete the analyses of both ReOpen1 and ReOpen2 and have begun the work necessary to seek a new indication that expands access to XHANCE for this broader group of patients. We would like to express our gratitude to the healthcare professionals at our research sites and, most especially, to all the patients with chronic sinusitis whose altruistic participation made it possible to offer new hope to others who suffer from the same symptom

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