Senior Brent A, Ow Randall A, Major M Scott, Silvers Stacey L, Rosenbloom Jeffrey S, Luong Amber U, Soler Zachary M, Naclerio Robert, Kern Robert C, Brayton Lindsay, Mihova Marina, Sajjadi Ela, Lee Misun, Belanger Vineeta, Nieman Richard
Department of Otolaryngology, Head and Neck Surgery, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
Sacramento Ear, Nose, and Throat, Roseville, California, USA.
Int Forum Allergy Rhinol. 2025 Aug;15(8):818-827. doi: 10.1002/alr.23567. Epub 2025 Mar 18.
Endoscopic sinus surgery (ESS) often fails to directly manage the underlying inflammation in chronic rhinosinusitis (CRS), resulting in symptom recurrence in a significant number of patients. LYR-220 is a long-acting (24-week) corticosteroid sinonasal implant being developed for treatment of these patients.
Forty-two adults with CRS and prior ESS were enrolled in the multicenter, randomized, controlled Phase 2 (BEACON) study. Patients received LYR-220 or a sham procedure bilaterally. The primary endpoint was occurrence of any treatment-related serious adverse events (SAEs). Efficacy endpoints included change from baseline (CFBL) in Sino-Nasal Outcome Test (SNOT-22); three cardinal symptoms (3CS) of CRS (nasal blockage, nasal discharge, and facial pain/pressure); loss-of-smell; ethmoid percent opacification volume; and need for rescue treatment (systemic corticosteroids [SCS] or sinonasal surgery).
No SAEs were reported in the study. SNOT-22 scores significantly improved with LYR-220 versus sham from week 2 onwards, with a between group difference of -16.8 at Week 24 (p = 0.007). Between group difference at Week 24 for 3CS was -1.50 (p = 0.02) and for ethmoid percent opacification volume was -8.14 (p = 0.035). Five patients from LYR-220 group and seven from sham group used SCS. LYR-220 showed improvement versus sham in the loss-of-smell from Week 8 through the end of treatment at 24 weeks (-0.87, p = 0.026).
The BEACON study demonstrated safety, efficacy, feasibility, and tolerability of LYR-220 in patients with CRS who have had prior ESS. The primary endpoint was met, with no SAEs reported. LYR-220 demonstrated statistically significant, clinically relevant improvements in key symptomatic and objective efficacy endpoints.
鼻内镜鼻窦手术（ESS）常常无法直接控制慢性鼻-鼻窦炎（CRS）的潜在炎症，导致大量患者症状复发。LYR-220是一种正在研发的长效（24周）皮质类固醇鼻窦植入物，用于治疗这些患者。
42例患有CRS且曾接受ESS的成年人参加了多中心、随机、对照的2期（BEACON）研究。患者双侧接受LYR-220或假手术。主要终点是任何与治疗相关的严重不良事件（SAE）的发生情况。疗效终点包括鼻-鼻窦结局测试（SNOT-22）相对于基线的变化（CFBL）；CRS的三个主要症状（3CS，即鼻塞、流涕和面部疼痛/压迫感）；嗅觉丧失；筛窦浑浊体积百分比；以及急救治疗需求（全身用皮质类固醇激素[SCS]或鼻窦手术）。
研究中未报告SAE。从第2周起，LYR-220组的SNOT-22评分相对于假手术组有显著改善，在第24周时组间差异为-16.8（p = 0.007）。第24周时3CS的组间差异为-1.50（p = 0.02），筛窦浑浊体积百分比的组间差异为-8.14（p = 0.035）。LYR-220组有5例患者、假手术组有7例患者使用了SCS。从第8周直至24周治疗结束，LYR-220组相对于假手术组在嗅觉丧失方面有改善（-0.87，p = 0.026）。
BEACON研究证明了LYR-220在既往接受过ESS的CRS患者中的安全性、有效性、可行性和耐受性。达到了主要终点，未报告SAE。LYR-220在关键的症状性和客观疗效终点方面显示出具有统计学意义的、临床相关的改善。
