Details
The U.S. Food and Drug Administration (FDA) initiated this study in the Sentinel System in response to safety concerns raised during the New Drug Application (NDA) review for Sinuva, particularly regarding the potential risks associated with a higher dose of mometasone furoate (MF) and repeated stent use. Sinuva is a mometasone furoate releasing implant used to treat nasal polyps in adults who have previously undergone ethmoid sinus surgery. The objective was to evaluate the incidence of adverse effects among patients receiving a single Sinuva implant compared to those with repeat implants, as well as compared to other MF-eluting implants, such as Propel.
Results indicated that Sinuva usage increased between 2018 and 2021 but declined sharply thereafter, with relatively few patients receiving repeat implants. Among new Sinuva users, rates of glaucoma, ocular hypertension, and cataracts were higher in the Sinuva group compared to Propel. However, the incidence of nasal septal perforation and diminished visual acuity was similar across both groups. These differences appeared to be influenced by age, as Sinuva users tended to be older. When stratified by age, the incidence rates between the two products were comparable. Given the absence of evidence indicating increased risk and the declining use of Sinuva, the FDA concluded that no regulatory action was necessary.