Waldemarus
- OptiNose (NASDAQ:OPTN) shares gained in post-market trading on Friday after the company announced the FDA approval of its request to expand the labeling for its lead product, Xhance, a drug-device combination indicated in the U.S. for chronic sinusitis.
- Accordingly, Xhance, designed to deliver a topical steroid to the nasal cavity, will be approved in the U.S. for treating chronic sinusitis in adults without nasal polyps.
- Previously, it was indicated for adults with nasal polyps in the U.S., and the FDA’s latest decision will allow OptiNose (OPTN) to market it for those without nasal polyps, who comprise more than two-thirds of chronic sinusitis patients.
- It is estimated that nearly 30M adults in the U.S. suffer from chronic sinusitis, also known as chronic rhinosinusitis.