Optinose, a pharmaceutical company specializing in treatments for ear, nose, and throat (ENT) and allergy conditions, has achieved a significant milestone with the approval of XHANCE® (fluticasone propionate) nasal spray by the U.S. Food and Drug Administration (FDA) for the treatment of chronic rhinosinusitis (CRS) without nasal polyps in patients 18 years and older. Chronic sinusitis, affecting approximately 30 million adults in the United States alone, poses a substantial burden on patients' quality of life and healthcare resources, with millions of outpatient visits and antibiotic prescriptions annually, as well as over 600,000 surgeries.

This approval marks a breakthrough for the treatment landscape of chronic sinusitis, addressing a critical unmet need for patients who do not have nasal polyps. XHANCE, utilizing Optinose's proprietary Exhalation Delivery System™, delivers fluticasone propionate to targeted areas of inflammation deep within the nose and sinuses, which are often not reached by standard nasal sprays. The approval was based on data from the ReOpen program, the first large placebo-controlled clinical trial program to demonstrate a statistically significant reduction in symptoms of chronic sinusitis without nasal polyps, along with reductions in sinus inflammation and acute exacerbations that frequently lead to antibiotic use.

Key opinion leaders in the field have expressed enthusiasm for XHANCE's approval, emphasizing its potential to improve treatment outcomes for CRS patients. Dr. Rick Chandra from Vanderbilt University highlights the significance of having an FDA-approved medication for this patient population, noting the limitations of previous therapies and the effectiveness of XHANCE demonstrated in rigorous clinical studies.

CEO of Optinose, Dr. Ramy Mahmoud, stresses the burden of chronic sinusitis on patients and the lack of effective prescription medications available until now. He underscores XHANCE's potential to become a standard of care for chronic sinusitis treatment, offering new hope to millions of patients who have struggled with uncontrolled symptoms and limited treatment options.

The safety profile of XHANCE observed in the ReOpen program was consistent with its current labeling, with the most common adverse reactions including epistaxis, headache, and nasopharyngitis. With this approval, XHANCE stands poised to provide significant relief for patients suffering from chronic sinusitis without nasal polyps, potentially revolutionizing the management of this debilitating condition.