Evaluation of LYR-220 Mometasone Sinonasal Implants in Patients With Chronic Rhinosinusitis and Prior Ethmoid Surgery: Results From the Randomized, Blinded, Controlled BEACON Phase 2 Study.

Abstract

Background: 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.

Methods: 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).

Results: 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).

Conclusions: 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.