Long‐acting implantable corticosteroid matrix for chronic rhinosinusitis: Results of LANTERN Phase 2 randomized controlled study

BACKGROUND: Topical steroids are first‐line treatment for chronic rhinosinusitis (CRS), but fail to provide adequate symptom control for all patients. Designed for medical treatment failures, LYR‐210 is an implantable matrix that locally elutes mometasone furoate to inflamed sinonasal tissue for up to 24 weeks in CRS patients. In an open‐label phase 1 study, LYR‐210 demonstrated clinically relevant improvement in the 22‐item Sino‐Nasal Outcome Test (SNOT‐22). Safety and efficacy of LYR‐210 in CRS were evaluated in the LANTERN Phase 2 study. METHODS: Sixty‐seven surgically naive adult CRS patients who were inadequately controlled by previous medical management and seeking an alternative treatment enrolled in a multicenter, blinded, controlled, dose‐ranging study. Patients had moderate‐to‐severe disease based on SNOT‐22 and composite 7‐day average scores of the 4 cardinal CRS symptoms (4CS), with diagnosis confirmed by nasal endoscopy and magnetic resonance imaging. Patients were randomized (1:1:1) to saline irrigation–only control or bilateral in‐office administration of LYR‐210 (2500 μg) or LYR‐210 (7500 μg). Safety and efficacy were evaluated over 24 weeks. RESULTS: Both LYR‐210 doses were safe and well‐tolerated over the 24‐week treatment period. LYR‐210 demonstrated rapid and durable dose‐dependent symptom improvement based on 4CS and SNOT‐22, with LYR‐210 (7500 μg) achieving statistical significance as early as 8 weeks and out to 24 weeks compared with control. LYR‐210 (7500 μg) reduced rescue treatment use and radiographic ethmoid opacification at week 24. CONCLUSIONS: LYR‐210 is the first implantable sinonasal treatment to achieve up to 24 weeks of benefit from a single administration in surgically naive CRS patients with and without nasal polyps.