According to today’s phase 3 data Optinose’s steroid nasal spray Xhance significantly improved the symptoms of chronic sinusitis and opening up of the nasal passages, as shown by CT imaging, versus placebo. With nothing else on the market for this disease, Xhance might be presumed to have a clear shot – and indeed the company has previously said that some doctors already prescribe the product off-label for sinusitis. The company’s share price opened down 3%, possibly owing to Optinose’s decision to schedule a conference call discussing the data for after today’s market close, but later recovered to trade up slightly. But there are reasons for caution, including the vanishingly slight dose response; the two doses assessed in the ReOpen1 study produced near-identical average reductions in symptom score despite one dose being twice as high as the other. Chronic sinusitis represents an important opportunity for Optinose; according to Evaluate Pharma’s sellside consensus sinusitis sales are set to be almost twice those in Xhance’s approved indication, nasal polyps. A second phase 3 sinusitis study, ReOpen2, is due to report by the summer, and this needs to replicate the positive topline findings to help ease Xhance's journey to market.
https://www.evaluate.com/vantage/articles/news/trial-results-snippets/optinose-breathes-easy
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