Core Insights - Lyra Therapeutics has outlined its clinical plan for LYR-210 following a meeting with the FDA, confirming the need for an additional clinical trial for NDA submission [2][3] - The positive results from the Phase 3 ENLIGHTEN 2 trial for LYR-210 were highlighted, demonstrating significant improvement in CRS symptoms [5][3] Company Overview - Lyra Therapeutics is a late clinical-stage biotechnology company focused on developing long-acting anti-inflammatory therapies for chronic rhinosinusitis (CRS) [1][9] - LYR-210 is a bioabsorbable sinonasal implant designed to deliver six months of continuous anti-inflammatory therapy to treat CRS [6][9] Clinical Trial Details - The ENLIGHTEN 2 trial met its primary endpoint, showing statistically significant improvement in CRS symptoms at week 24 compared to sham control [5] - The trial also achieved key secondary endpoints, with symptom improvement observed as early as week 4 [5] Future Plans - The company plans to refine the design of the upcoming clinical trial based on insights from previous trials and FDA feedback [3] - A late-breaking oral presentation of the ENLIGHTEN 2 results is scheduled for the AAO-HNS Annual Meeting on October 13, 2025 [3][8]

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]