Lyra Therapeutics announces clinical plan for LYR-210

Lyra Therapeutics (LYRA) announced the Company’s clinical plan and upcoming oral presentation of results from the positive Phase 3 ENLIGHTEN 2 trial for LYR-210, the company’s lead product candidate for CRS. Lyra plans to proceed with an additional clinical trial that was confirmed as a requirement for submission of a New Drug Application for LYR-210 for the treatment of CRS without nasal polyps, based on a September 2025 meeting with the U.S. Food and Drug Administration.Lyra also announced a late-breaking oral presentation of the positive ENLIGHTEN 2 Phase 3 results at the Annual Meeting of the American Academy of Otolaryngology-Head and Neck Surgery, taking place October 11-14 in Indianapolis. In June 2025, Lyra announced positive results from the ENLIGHTEN 2 Phase 3 clinical trial of LYR-210 in adult patients with CRS. The ENLIGHTEN 2 trial met its primary endpoint, with LYR-210 demonstrating statistically significant improvement compared to sham control in a composite of the three cardinal symptoms of CRS at week 24 in patients without nasal polyps. The ENLIGHTEN 2 trial also met the key secondary endpoints of 3CS at 24 weeks in the full population and in the clinically-validated SNOT-22 score at 24 weeks, with symptom improvement observed as early as week 4. Consistent with previous studies, LYR-210 was generally well-tolerated, with a safety profile similar to sham control. The 24-week endpoints in the ENLIGHTEN trials assess LYR-210’s long-acting therapeutic effect as a bioresorbable sinonasal implant designed to deliver six months of continuous anti-inflammatory medication to the sinonasal passages.