Lyra Therapeutics Announces Clinical Plan for LYR-210 and Late-Breaking Oral Presentation of Phase 3 ENLIGHTEN 2 Study

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]