XHANCE^® (fluticasone propionate)

Chronic Sinusitis

In addition to XHANCE’s indication for the treatment of nasal polyps, in order to broaden our U.S. market opportunity, we conducted a clinical trial program in pursuit of a follow-on indication for the treatment of CS in the U.S. We announced positive top-line results from the clinical trials in March and June 2022 and submitted a supplemental new drug application (sNDA) in February 2023. The sNDA was approved in March 2024. In the future, as appropriate, we intend to broaden, through potential collaborations, our commercialization efforts to additional primary care physicians that we believe treat an additional estimated 6.25 million U.S. patients with chronic rhinosinusitis. In addition, at some point in the future, we intend to consider, with a collaboration partner, directing promotional resources to an additional estimated 20 million adults who are not regularly under the care of physicians for this disease using programs such as direct-to-consumer and direct-to-patient promotion.

Other

We opportunistically evaluate opportunities to develop product candidates using the EDS and related technologies for indications and markets outside of our ENT and allergy focus through business development and partnering activities. Although our current focus is to prioritize the successful commercialization of XHANCE for the ENT and allergy specialty segment and the pursuit of FDA approval of XHANCE for the treatment of chronic sinusitis, we may apply or out-license the EDS and related technology to other product candidates across a broad range of disease areas.