Optinose's XHANCE Meets Primary Endpoints In Chronic Sinusitis Trial

Optinose Inc OPTN has announced positive data from the ReOpen1 Phase 3 trial of Xhance (fluticasone propionate) Exhalation Delivery System in chronic sinusitis.

  • The trial met both of its co-primary endpoints - First, a composite symptom score (comprising nasal congestion, facial pain or pressure, and nasal discharge) and second, an objective measure of disease in the sinus cavities.
  • A statistically significant improvement was demonstrated in patients with chronic sinusitis treated with the Xhance compared to patients receiving an Exhalation Delivery System placebo.
  • The Company expects topline results from ReOpen2, the second of its two Phase 3 trials for Xhance in chronic sinusitis, in Q2 of 2022.
  • The safety profile and tolerability of Xhance were generally consistent with its currently labeled safety profile. 
  • Adverse events occurring at a rate of more than 3% with Xhance and more common than the Exhalation Delivery System placebo group were: epistaxis, nasopharyngitis, asthma, and cataract (nuclear and cortical).
  • Detailed results from the trial will be submitted for publication in a peer-reviewed journal and presentation at future medical meetings.
  • Price Action: OPTN shares are up 2.21% at $2.78 during the market session on the last check Monday.
Market News and Data brought to you by Benzinga APIs
Comments
Loading...
Posted In: BiotechNewsPenny StocksHealth CareMoversTrading IdeasGeneralBriefsPhase 3 Trial
Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!