Recent Updates
Recently added Catalysts

LYR-210

Phase 3

Chronic Sinusitis | Small molecule | ENT |Lyra Therapeutics, Inc.|Last Updated: Feb 19, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindSHAM_CONTROLLEDDMCBiomarker
Total Trials3
Total Enrollment449
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05295459Efficacy and Safety of LYR-210 for the Treatment of Chronic Rhinosinusitis in Adults (ENLIGHTEN 2)PHASE3 COMPLETED 182May 13, 2022Apr 2, 2025Feb 19, 202657 United States, Belgium +4
NCT05219968Efficacy and Safety of LYR-210 for the Treatment of Chronic Rhinosinusitis in AdultsPHASE3 COMPLETED 196Jan 27, 2022Sep 16, 2024May 2, 202555 United States, Austria +3
NCT04041609LYR-210 Depot (LYR-210) for Adult Subjects With Chronic Sinusitis (LANTERN Study)PHASE2 COMPLETED 71May 9, 2019Feb 4, 2021Jul 25, 202322 Australia, Austria +3
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Change From Baseline (CFBL) in the 7-day Average Composite Score of 3 Cardinal Symptoms (3CS) in Participants Without Nasal Polyps
Week 24

The 3CS are nasal blockage/obstruction/congestion, anterior/posterior nasal discharge, and facial pain/pressure. The diary is completed daily by study participants throughout the study. Each symptom is rated on a 4-point (0-3) scale where 0= none/absent symptoms, 1=mild symptoms, 2=moderate symptoms, and 3=severe symptoms. The composite score of 3CS is the sum of the three cardinal symptom scores. The 3CS total score ranges from 0-9, with higher scores indicating worse symptoms.

Change From Baseline (CFBL) in the 7-day Average Composite Score of 3 Cardinal Symptoms (3CS) in Participants Without Nasal Polyps.
24 Weeks

The 3CS are nasal blockage/obstruction/congestion, anterior/posterior nasal discharge, and facial pain/pressure. The diary is completed daily by study participants throughout the study. Each symptom/each question is rated on a 4-point (0-3) scale where 0= none/absent symptoms, 1=mild symptoms, 2=moderate symptoms, and 3=severe symptoms. The composite score of 3CS is the sum of the three cardinal symptom scores. The 3CS total score ranges from 0-9, with higher scores indicating worse symptoms.

Change From Baseline (CFBL) in Chronic Sinusitis Symptom Scores at Week 4
Week 4

Participants score their CS symptoms on a 4-point scale as follows: 0 = absent symptoms (no sign/symptom evident), 1 = mild symptoms (sign/symptom present but minimal awareness; easily tolerated), 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable), 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping). The scores are summed and averaged over the proceeding 7 days; higher scores indicate higher severity of symptoms of CS.

Secondary Endpoints
CFBL in the 7-day Average Composite Score of 3CS in All Participants at Week 24
Week 24
CFBL in the 22-item Sino-Nasal Outcome Test (SNOT-22) Total Score at Week 24
Week 24
CFBL in the 3-D Volumetric CT Score at Week 20
Week 20
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
LYR-210EXPERIMENTALSingle administration of LYR-210 drug matrix (7500 μg)
Sham procedure controlSHAM_COMPARATORSingle mock administration procedure
LYR-210 (Low Dose)EXPERIMENTALIn-office bilateral placement of the LYR-210 drug depot (mometasone furoate low dose) in the middle meatus
LYR-210 (High Dose)EXPERIMENTALIn-office bilateral placement of the LYR-210 drug depot (mometasone furoate high dose) in the middle meatus
Sham ProcedureSHAM_COMPARATORIn-office bilateral sham procedure
Interventions
NameTypeDescription
LYR-210DRUGLYR-210 drug matrix (mometasone furoate)
Sham procedure controlDRUGSham procedure control
Background therapyOTHERDaily Saline Irrigation
Sham comparatorOTHERSham comparator
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites57

Inclusion Criteria: * Age ≥18 * Diagnosed as having CRS * Bilateral ethmoid disease confirmed on CT * Mean 3 cardinal symptom (3CS) score * Undergone at least 2 trials of medical treatments in the past * Has been informed of the nature of the study and provided written informed consent * Agrees to ...

Countries:United StatesBelgiumBulgariaGermanyHungaryPolandAustriaCzechiaSpainAustraliaNew Zealand
Unlock Eligibility Criteria
Competitive Landscape -Chronic Rhinosinusitis 12 trials