Waldemarus
- OptiNose (NASDAQ: OPTN) shares gained in post-market trading on Friday after the company announced FDA approval of its application to expand the labeling of its lead product, Xhance, a drug-device combination indicated in the US. for chronic sinusitis.
- Consequently, Xhance, designed for Administering a topical steroid into the nasal cavity will be approved in the US for the treatment of chronic sinusitis in adults without nasal polyps.
- It was previously indicated for adults with nasal polyps in the US, and the latest FDA decision will allow OptiNose (OPTN) to market it to those without nasal polyps, who make up more than two-thirds of chronic sinusitis patients.
- It is estimated that nearly 30 million adults in the US suffer from chronic sinusitis, also known as chronic rhinosinusitis.
