{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,14]],"date-time":"2026-05-14T16:57:18Z","timestamp":1778777838762,"version":"3.51.4"},"reference-count":30,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2019,1,15]],"date-time":"2019-01-15T00:00:00Z","timestamp":1547510400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"name":"Lyra Therapeutics, Inc."}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Int Forum Allergy Rhinol"],"published-print":{"date-parts":[[2019,4]]},"abstract":"<jats:sec><jats:title>Background<\/jats:title><jats:p>Chronic rhinosinusitis (CRS) patients who fail medical management have few treatment options other than endoscopic sinus surgery (ESS). A novel biodegradable mometasone furoate drug delivery system (LYR\u2010210) providing continuous topical steroid therapy to sinonasal mucosa over 24 weeks was developed to treat unoperated CRS patients who have failed medical management prior to ESS. LYR\u2010210 was designed to slowly expand in the middle meatus, ensuring efficient drug delivery as mucosal swelling reduces.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>A prospective, multicenter, open\u2010label study was conducted in 20 CRS subjects who were determined to be candidates for ESS. Under endoscopic guidance and topical anesthesia, LYR\u2010210 was placed in both middle meatuses. The primary endpoint was product\u2010related serious adverse events (SAEs) at 4 weeks. Additional assessments included plasma drug concentration, morning serum cortisol levels, intraocular pressures (IOPs), and Sino\u2010Nasal Outcome Test (SNOT\u201022) scores.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>LYR\u2010210 was successfully placed bilaterally in 20 subjects (12 without nasal polyps and 8 with polyps) in an office setting. There were no product\u2010related SAEs through 24 weeks, at which point 86% of LYR\u2010210 depots were still retained in the middle meatus. Serum cortisol, IOP, and plasma drug concentrations supported systemic safety at all time points tested. Subjects experienced significant reductions in their SNOT\u201022 scores as early as week 1, and this reduction persisted through week 24 (<jats:italic>p<\/jats:italic> &lt; 0.01). Significant symptom improvement was achieved in the SNOT\u201022 rhinologic, extranasal rhinologic, ear\u2010facial, psychological, and sleep dysfunction subdomains at 24 weeks (<jats:italic>p<\/jats:italic> &lt; 0.05).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>LYR\u2010210 is safe and well\u2010tolerated in ESS\u2010naive CRS patients and leads to sustained symptom improvement in patients.<\/jats:p><\/jats:sec>","DOI":"10.1002\/alr.22288","type":"journal-article","created":{"date-parts":[[2019,1,15]],"date-time":"2019-01-15T19:04:41Z","timestamp":1547579081000},"page":"378-387","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":16,"title":["Phase 1 clinical study to assess the safety of a novel drug delivery system providing long\u2010term topical steroid therapy for chronic rhinosinusitis"],"prefix":"10.1002","volume":"9","author":[{"given":"Richard G.","family":"Douglas","sequence":"first","affiliation":[{"name":"Department of Surgery The University of Auckland  Auckland New Zealand"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alkis J.","family":"Psaltis","sequence":"additional","affiliation":[{"name":"Department of Otolaryngology Head and Neck Surgery The Queen Elizabeth Hospital  Woodville South South Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joanne","family":"Rimmer","sequence":"additional","affiliation":[{"name":"Monash Health  Melbourne Australia"},{"name":"Department of Surgery Monash University  Melbourne Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tom","family":"Kuruvilla","sequence":"additional","affiliation":[{"name":"Otolaryngology\u2013Head and Neck Surgery Specialists at Forte 2  Christchurch New Zealand"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anders","family":"Cervin","sequence":"additional","affiliation":[{"name":"University of Queensland Centre for Clinical Research Royal Brisbane &amp; 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