Skip to main content
AAO-HNSF 2025 Annual Meeting & OTO EXPO Main banner
Icon Legend
This session is not in your schedule.
This session is in your schedule. Click again to remove it.

Late-Breaking Scientific Oral Presentations

Rhinology/Allergy

Session: Late Breaking Scientific Orals 3

LYR-210 Long-acting Sinonasal Implants for Chronic Rhinosinusitis: Results from the Phase 3 ENLIGHTEN 2 Study

Monday, October 13, 2025
4:48 PM - 4:54 PM EDT
Location: 233-234
Introduction: LYR-210 is a sinonasal implant designed to deliver 24 weeks of continuous anti-inflammatory therapy (7500µg mometasone furoate) to the sinonasal mucosa in patients with chronic rhinosinusitis (CRS) who remain symptomatic despite standard medical management. The ENLIGHTEN 2 pivotal trial (NCT05295459) evaluated the efficacy and safety of LYR-210 in adults with CRS through 24 weeks.

Methods: This randomized, multi-center, blinded, sham-controlled trial enrolled adult CRS patients without nasal polyps or with grade 1 polyps, who had failed prior medical management and had not previously undergone ethmoid sinus surgery. Between September 2022 and October 2024, 172 patients were randomized (2:1) to receive either LYR-210 or sham procedure bilaterally in an in-clinic procedure. The primary endpoint was the change from baseline (CFBL) in the weekly average composite score of the 3 CRS cardinal symptoms (3CS; nasal congestion, nasal discharge, and facial pain) at Week 24. Secondary endpoints were CFBL in the SNOT-22 total score and in the percent ethmoid opacification assessed by computed tomography, and the proportion of patients needing rescue treatment. Safety was assessed via adverse event (AE) collection, labs, nasal endoscopies, and ocular exams.

Results: The LYR-210 treatment group achieved improvement in mean 3CS scores at Week 24 compared to sham control for a difference of -1.13 (p=0.008). At Week 24, mean SNOT-22 scores improved by 22.4 points in the LYR-210 group compared to 13.7 points in the sham group for a difference of -8.7 points (p=0.01). In the objective endpoint of percent ethmoid opacification, LYR-210 showed an improvement over sham with a difference of -2.15 (p=0.18). LYR-210 was generally well-tolerated with no treatment-related serious AE. The most common AEs reported at a higher rate in LYR-210 compared to sham were epistaxis, upper respiratory tract infection, acute sinusitis, and headache.

Conclusions: In this study, LYR-210 was well-tolerated and demonstrated statistically significant and clinically meaningful improvements in symptoms and quality of life in patients with CRS.

    Presenting Author(s)

  • ZS

    Zachary M. Soler, MD, MSc

    Professor of Otolaryngology
    Medical University of Sourth Carolina
    Charleston, SC, United States

    Disclosure information not submitted.

    • Co-Author(s)

  • JL

    Jivianne T. Lee, MD

    Professor
    UCLA School of Medicine
    Los Angeles, CA, United States

    Disclosure information not submitted.

  • RN

    Robert M. Naclerio, MD

    Johns Hopkins University, United States

    Disclosure information not submitted.

  • BS

    Brent A. Senior, MD

    Harold C. Pillsbury, III Distinguished Professor
    Department of Otolaryngology-Head & Neck Surgery
    Chapel Hill, NC, United States

    Disclosure information not submitted.

  • RK

    Robert Kern, MD

    Northwestern Medical, United States

    Disclosure information not submitted.

    • Senior Author(s)

  • RK

    Robert Kern, MD

    Northwestern Medical, United States

    Disclosure information not submitted.

    • Co-Author(s)

  • VB

    Vineeta S. Belanger, PhD

    SVP Clinical Affairs
    Lyra Therapeutics
    Waltham, MA, United States

    Disclosure information not submitted.