mometasone fuorate (LYR-210) / Lyra Therap - LARVOL DELTA

LYR-210 Long-acting Sinonasal Implants for Chronic Rhinosinusitis: Results from the Phase 3 ENLIGHTEN 2 Study (AAO-HNSF 2025) - P3 | "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."

Late-breaking abstract • P3 data • Immunology • Infectious Disease • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis

Efficacy and Safety of LYR-210 for the Treatment of Chronic Rhinosinusitis in Adults (ENLIGHTEN 2) (clinicaltrials.gov) - P3 | N=182 | Completed | Sponsor: Lyra Therapeutics | Active, not recruiting ➔ Completed

Trial completion • Otorhinolaryngology • Respiratory Diseases • Sinusitis

Results from CRSwNP patients from the ENLIGHTEN phase 3 program of LYR-210 in CRS (COSM 2025) - "Results from the pooled data in the ENLIGHTEN program provide support for the potential benefit of LYR-210 in treatment of CRS patients who have nasal polyps."

Clinical • P3 data • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps • Otorhinolaryngology • Pain • Respiratory Diseases • Sinusitis

52-week outcomes from the Phase 3 ENLIGHTEN 1 trial for LYR-210 in CRS (COSM 2025) - "LYR-210 was well-tolerated throughout the 52-week ENLIGHTEN 1 trial."

P3 data • Immunology • Nasal Polyps • Otorhinolaryngology • Pain • Respiratory Diseases • Sinusitis

Lyra Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Corporate Update (GlobeNewswire) - "Milestones for ongoing ENLIGHTEN pivotal program of LYR-210 in CRS: (i) Topline results from the ENLIGHTEN 2 pivotal Phase 3 clinical trial of LYR-210 are expected in Q2 2025; (ii) We expect an additional ~30 polyp patients in the ENLIGHTEN 2 trial, which combined with the 35 polyp patients in the ENLIGHTEN 1 trial, would result in a total of ~65 polyp patients in the ENLIGHTEN program."

Enrollment change • P3 data: top line • Chronic Rhinosinusitis With Nasal Polyps

Efficacy and Safety of LYR-210 for the Treatment of Chronic Rhinosinusitis in Adults (ENLIGHTEN 2) (clinicaltrials.gov) - P3 | N=180 | Active, not recruiting | Sponsor: Lyra Therapeutics | Trial completion date: Dec 2024 ➔ Apr 2025 | Trial primary completion date: Dec 2024 ➔ Apr 2025 | Recruiting ➔ Active, not recruiting

Enrollment closed • Trial completion date • Trial primary completion date • Otorhinolaryngology • Respiratory Diseases • Sinusitis

Lyra Therapeutics Fully Enrolls Pivotal Phase 3 ENLIGHTEN 2 Trial of LYR-210 for the Treatment of Chronic Rhinosinusitis (GlobeNewswire) - "Lyra Therapeutics, Inc...announced that the pivotal Phase 3 ENLIGHTEN 2 clinical trial of LYR-210 in adult patients with CRS who have not had prior ethmoid sinus surgery, is fully enrolled. LYR-210 is a bioresorbable nasal implant designed to deliver six months of continuous anti-inflammatory medication (mometasone furoate) to the sinonasal passages for the treatment of CRS. Topline results from ENLIGHTEN 2 are expected in Q2 2025."

Enrollment closed • P3 data: top line • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Sinusitis

ENLIGHTEN 1: Efficacy and Safety of LYR-210 for the Treatment of Chronic Rhinosinusitis in Adults (clinicaltrials.gov) - P3 | N=196 | Completed | Sponsor: Lyra Therapeutics | Active, not recruiting ➔ Completed

Trial completion • Otorhinolaryngology • Respiratory Diseases • Sinusitis

Efficacy and Safety of LYR-210 for the Treatment of Chronic Rhinosinusitis in Adults (ENLIGHTEN 2) (clinicaltrials.gov) - P3 | N=180 | Recruiting | Sponsor: Lyra Therapeutics | Trial completion date: Jan 2024 ➔ Dec 2024 | Trial primary completion date: Jan 2024 ➔ Dec 2024

Trial completion date • Trial primary completion date • Otorhinolaryngology • Respiratory Diseases • Sinusitis

ENLIGHTEN 1: Efficacy and Safety of LYR-210 for the Treatment of Chronic Rhinosinusitis in Adults (clinicaltrials.gov) - P3 | N=180 | Active, not recruiting | Sponsor: Lyra Therapeutics | Recruiting ➔ Active, not recruiting | Trial completion date: Mar 2024 ➔ Sep 2024 | Trial primary completion date: Aug 2023 ➔ Mar 2024

Enrollment closed • Trial completion date • Trial primary completion date • Otorhinolaryngology • Respiratory Diseases • Sinusitis

Efficacy and Safety of LYR-210 for the Treatment of Chronic Rhinosinusitis in Adults (ENLIGHTEN 2) (clinicaltrials.gov) - P3 | N=180 | Recruiting | Sponsor: Lyra Therapeutics | Active, not recruiting ➔ Recruiting

Enrollment open • Otorhinolaryngology • Respiratory Diseases • Sinusitis

Impact of long-acting implantable LYR-210 corticosteroid matrices on quality of life of patients with chronic rhinosinusitis in the LANTERN study. (PubMed, Int Forum Allergy Rhinol) - "Long-acting, local anti-inflammatory treatments that improve the QoL of CRS patients are needed. LYR-210 (7500?g) significantly improved scores for SNOT-22 subdomains and SF-36v2 at week 24."

HEOR • Journal • Otorhinolaryngology • Respiratory Diseases • Sinusitis

Efficacy and Safety of LYR-210 for the Treatment of Chronic Rhinosinusitis in Adults (ENLIGHTEN 2) (clinicaltrials.gov) - P3 | N=180 | Active, not recruiting | Sponsor: Lyra Therapeutics | Recruiting ➔ Active, not recruiting

Enrollment closed • Otorhinolaryngology • Respiratory Diseases • Sinusitis

Efficacy, Safety, Tolerability Study of LYR-210 Depot in Chronic Sinusitis A LYR-210 hatékonysági, biztonságossági és tolerálhatósági vizsgálata krónikus sinusitisben (clinicaltrialsregister.eu) - P3 | N=180 | Ongoing | Sponsor: Lyra Therapeutics, Inc.

New P3 trial • Dermatology • Infectious Disease • Otorhinolaryngology • Respiratory Diseases • Sinusitis

Pharmacokinetic Evidence of Steady and Sustained Drug Release from Long-Acting Implantable Corticosteroid Matrices for Chronic Rhinosinusitis. (PubMed, Am J Rhinol Allergy) - "LYR-210 achieved dose-dependent, continuous local MF delivery at a steady rate with low systemic exposure for months."

Clinical • Journal • PK/PD data • Otorhinolaryngology • Respiratory Diseases • Sinusitis

Efficacy and Safety of LYR-210 for the Treatment of Chronic Rhinosinusitis in Adults (ENLIGHTEN 2) (clinicaltrials.gov) - P3 | N=180 | Recruiting | Sponsor: Lyra Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Otorhinolaryngology • Respiratory Diseases • Sinusitis

LYR-210 Depot (LYR-210) for Adult Subjects With Chronic Sinusitis (LANTERN Study) (clinicaltrials.gov) - P2 | N=71 | Completed | Sponsor: Lyra Therapeutics | N=191 ➔ 71

Enrollment change • Otorhinolaryngology • Respiratory Diseases • Sinusitis

Efficacy and Safety of LYR-210 for the Treatment of Chronic Rhinosinusitis in Adults (ENLIGHTEN 2) (clinicaltrials.gov) - P3 | N=180 | Not yet recruiting | Sponsor: Lyra Therapeutics

New P3 trial • Otorhinolaryngology • Respiratory Diseases • Sinusitis

ENLIGHTEN 1: Efficacy and Safety of LYR-210 for the Treatment of Chronic Rhinosinusitis in Adults (clinicaltrials.gov) - P3 | N=180 | Recruiting | Sponsor: Lyra Therapeutics

New P3 trial • Otorhinolaryngology • Respiratory Diseases • Sinusitis

LYR-210 Depot (LYR-210) for Adult Subjects With Chronic Sinusitis (LANTERN Study) (clinicaltrials.gov) - P2; N=191; Completed; Sponsor: Lyra Therapeutics; Active, not recruiting ➔ Completed; N=110 ➔ 191

Clinical • Enrollment change • Trial completion • Otorhinolaryngology • Respiratory Diseases • Sinusitis

Long-acting implantable corticosteroid matrix for chronic rhinosinusitis: Results of LANTERN Phase 2 randomized controlled study. (PubMed, Int Forum Allergy Rhinol) - "LYR-210 is the first implantable sinonasal treatment to achieve up to 24 weeks of benefit from a single administration in surgically naive CRS patients with and without nasal polyps."

Clinical • Journal • P2 data • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis • MRI

LYR-210 Depot (LYR-210) for Adult Subjects With Chronic Sinusitis (LANTERN Study) (clinicaltrials.gov) - P2; N=110; Active, not recruiting; Sponsor: Lyra Therapeutics; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Sinusitis

Phase 1 clinical study to assess the safety of a novel drug delivery system providing long-term topical steroid therapy for chronic rhinosinusitis. (PubMed, Int Forum Allergy Rhinol) - "LYR-210 is safe and well-tolerated in ESS-naive CRS patients and leads to sustained symptom improvement in patients."

Clinical • Journal • P1 data

Lyra Therapeutics completes $30 million series C financing (Businesswire) - "Lyra Therapeutics, Inc., a clinical-stage therapeutics company focused on the development and commercialization of novel integrated drug and delivery solutions for the localized treatment of patients with ear, nose and throat diseases, today announced it has completed a Series C financing which raised $30 million in new funds...Lyra plans to use the proceeds for the advancement of the company’s lead product candidates, LYR-210 and LYR‑220, and for general corporate purposes."

Financing