NCX 4251 0.1% once daily treatment selected to advance into a larger Phase 2b clinical trial planned to start before the end of 2020
We successfully completed a Type C meeting with the U.S. Food and Drug Administration (FDA) and agreed on NCX 4251 Phase 2b trial designs in both acute exacerbations of blepharitis and the reduction of signs and symptoms of dry eye disease. We plan to start a Phase 2b efficacy and safety trial of NCX 4251 0.1% once a day including both blepharitis and dry eye endpoints. Based on the outcome of a meeting with the U.S. FDA, Nicox has the option to declare either the blepharitis endpoint or dry eye endpoints as the primary efficacy outcome of this trial. The Phase 2b trial, Mississippi, is planned to be initiated before the end of 2020.
Non dimentichiamoci di questa molecola; è meno importante dell'NCX470, ma se avesse successo, l'impatto sul corso del titolo sarebbe dirompente.