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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

Disclosure(s):

Zachary M. Soler, MD, MSc:

faculty for this accredited education activity has no relationship(s) with ineligible companies to disclose.

Jivianne T. Lee, MD:

faculty for this accredited education activity has no relationship(s) with ineligible companies to disclose.

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(s):
faculty for this accredited education activity has no relationship(s) with ineligible companies to disclose.

Co-Author(s)

Jivianne T. Lee, MD

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

Disclosure(s):
faculty for this accredited education activity has no relationship(s) with ineligible companies to disclose.
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, North Carolina, United States

Disclosure information not submitted.
Robert C. Kern, MD

George A. Sisson Professor and Chairman
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States

Disclosure information not submitted.

Senior Author(s)

Robert C. Kern, MD

George A. Sisson Professor and Chairman
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 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.