OptiNose touted data from a pair of Phase III clinical trials proving the safety and efficacy of its exhaled breath drug delivery treatment for chronic rhinosinusitis patients with and without polyps.
The company presented the data today at the American Rhinologic Society’s annual meeting in San Diego.
Data from both trials showed limited adverse effects from the fluticasone exhalation delivery system and significant improvement in symptoms and quality of life. Patients with nasal polyps experienced noteworthy reduction in polyp grade, the Pennsylvania-based company reported.
The device is a closed palate, bi-directional exhalation delivery system that’s powered by the user’s breath to propel medication into the nasal cavity. The user exhales into the device, closing their soft palate and sealing off the nasal cavity. The breath carries medication from the device to one side of the nose using a nosepiece.
After passing through the nasal cavity, the exhaled breath balances the pressure across the soft palate and opens a passage so it can exit through the other side of the nose, instead of the patient’s throat or lung.
OptiNose markets the technique as an alternative to oral and injected methods, because its delivery system can manage powder and liquid medication formulas.
“We are thrilled to present Phase III data on the use of our fluticasone exhalation delivery system (EDS-FLU), which we believe can help to better treat this deeply underserved patient population,” CEO Peter Miller said in prepared remarks. “Although almost everyone with this disease tries conventional nasal steroid sprays at some point, including in many instances before or after nasal surgery, many continue to suffer from chronic symptoms. Based on the Phase III data announced today, we are confident that EDS-FLU has potential to really help patients and we look forward to completing the next steps to make this important product available to doctors and patients, including filing of a new drug application with the FDA.”