Optinose Announces the Publication of ReOpen Phase 3 Clinical Trial Program Evaluating XHANCE in the Journal of Allergy and Clinical Immunology

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The safety profile and tolerability of XHANCE for patients in the ReOpen trials was generally consistent with its currently labeled safety profile. The most common adverse reactions (incidence ≥ 3%) in the ReOpen program were epistaxis, headache, and nasopharyngitis.

“With the help of patients and doctors in many countries, after years of effort, we are thrilled to see that results from these two pivotal trials are now available in a peer reviewed publication. Not only do these data support the sNDA we filed with FDA in 2023,” stated John Messina, PharmD, Senior Vice President of Clinical Research and Medical Affairs, “but they represent the first body of large, controlled trial evidence we are aware of showing that any nasal medication can produce improvement in symptoms and can reduce inflammation inside the sinus cavities of patients suffering from chronic sinusitis either with or without concurrent nasal polyps. Our team is proud of this breakthrough in the treatment of chronic sinusitis, and we sincerely thank the healthcare professionals who advised us along the way as well as those at our research sites and all the patients whose participation made this program possible.”

About the ReOpen Program
The ReOpen program comprised two global, randomized, double-blind, placebo-controlled Phase 3 trials that evaluated the efficacy and safety of one or two sprays of XHANCE in each nostril twice daily, over 24 weeks, in patients suffering from chronic sinusitis. In ReOpen1, the first of the two trials, 332 chronic sinusitis patients either with or without concurrent nasal polyps were treated. In ReOpen2, 222 chronic sinusitis patients who did not have polyps in the nasal cavity were treated. The co-primary endpoints were change from baseline in symptoms, as measured by composite symptom score (nasal congestion, facial pain or pressure, and nasal discharge) at the end of week 4, and change in inflammation inside the sinus cavities, as measured by CT scans (change in the average of the percentages of volume occupied by disease in the ethmoid and maxillary sinuses) at week 24. The ReOpen trial program is a landmark research program that included the first ever large, controlled trials we are aware of to demonstrate that any nasal medication produces significant improvement in both symptoms and inflammation inside the sinuses for patients with chronic sinusitis, regardless of whether or not nasal polyps are present, and to demonstrate significant reduction in the number of acute exacerbations.