Company outlines clinical plan for LYR-210 based on FDA meeting on the path to NDA submission Positive ENLIGHTEN 2 results highlighted at the AAO-HNS 2025 Annual Meeting WATERTOWN, Mass., Oct. 06, 2025 (GLOBE NEWSWIRE) -- Lyra Therapeutics, Inc. (Nasdaq: LYRA), (“Lyra” or the “Company”), a late clinical-stage biotechnology company developing long-acting anti-inflammatory therapies for the localized treatment of chronic rhinosinusitis (CRS), today announced the Company’s clinical plan and upcoming oral pres ...

ENLIGHTEN 2 Study Results - The ENLIGHTEN 2 study met its primary endpoint, demonstrating a statistically significant improvement over sham in 3CS at Week 24 in CRS patients without nasal polyps[42] - Key secondary endpoints of change in 3CS and SNOT-22 in the full study population were also met, showing statistically significant results at Week 24[42] - The study showed a numerical improvement in the key secondary endpoint of change in % ethmoid opacification (CT)[42] - The trial demonstrated a favorable safety profile with no product-related serious adverse events reported[42] Patient Demographics & Adverse Events - In the LYR-210 group (n=111), 60.4% of patients experienced any treatment-emergent adverse events (TEAEs), compared to 44.3% in the Sham group (n=61)[27] - Epistaxis was more frequent in the LYR-210 group (16.2%) compared to the Sham group (1.6%)[27] Market Opportunity & Product Design - Approximately 8 million people in the United States have CRS with nasal polyps, and around 4 million have CRS without nasal polyps[9] - The annual healthcare expenditure for CRS in the United States is approximately $60 billion[9] - Lyra's product is designed to deliver 6 months of continuous, local drug therapy with a single placement[13,17] Pooled Analysis - In the pooled ENLIGHTEN 1 and ENLIGHTEN 2 patients with grade 1 nasal polyps, there was a consistent, positive trend in symptomatic endpoints starting in Week 4 and throughout Week 24[42]