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LYR-210 Nasal Implant for CRS Brings Symptom Relief in Phase 3 ENLIGHTEN 2
Lyra Therapeutics announced LYR-210 met primary and secondary endpoints in phase 3 ENLIGHTEN 2, improving CRS symptoms and showing strong safety.
The ENLIGHTEN 2 phase 3 trial demonstrated the success of LYR-210, a bioabsorbable nasal implant, in alleviating cardinal symptoms of chronic rhinosinusitis (CRS).
Announced by Lyra Therapeutics on June 2, 2025, the company reported that ENLIGHTEN 2 met its primary endpoint. By week 24, LYR-210 showed significant improvement over sham in 3 cardinal CRS symptoms—nasal obstruction, nasal discharge, and facial pain/pressure (-1.13; P = .0078)—in patients without nasal polyps.
“The positive results seen in the ENLIGHTEN 2 study are impressive and represent what could be a promising new treatment approach for the many CRS patients that I see every day in my practice who are underserved by limited therapies,” said lead investigator Zachary Soler, MD, MSc, professor in the department of otolaryngology-head and neck surgery at the Medical University of South Carolina, in a statement. “The more than 20-point improvement from baseline in SNOT-22 score after LYR-210 treatment represents a clinically meaningful improvement in patient symptoms.”
LYR-201 is an investigational product candidate for CRS in patients unresponsive to current treatments. This implant, inserted via a simple, in-office procedure, delivers 6 months of continuous anti-inflammatory therapy, mometasone furoate, to the sinonasal passages.
ENLIGHTEN 2 also met key secondary endpoints at week 24, showing significant improvement in the 3 cardinal symptoms across the full population (patients with and without nasal polyps) (-0.90; P = .0209) and in SNOT-22 score (-8.4; P = .0101). Improvement in SNOT-22 was seen as early as week 4 (-6.4; P = .0456) and continued throughout week 24, exceeding twice the minimal clinically important difference (22.4 points).
Computed tomography (CT) scans showed numerical improvement in ethmoid sinus opacification in patients treated with LYR-201 vs sham at week 20 (-2.15; P = .1809), providing objective radiological evidence of improvement with LYR-210 treatment.
Use of corticosteroid rescue medication was similar between groups, but Lyra noted that fewer patients receiving LYR-210 required endoscopic sinus surgery compared to sham.
LYR-210 was well-tolerated, with a comparable safety to the sham control and no serious adverse events. The most common adverse events included epistaxis, upper respiratory tract infection, chronic sinusitis, acute sinusitis, nasopharyngitis, COVID-19, and headache.
A pooled analysis of ENLIGHTEN 1 and ELIGHTEN 2 involving 64 CRS patients with small nasal polyps showed a consistent positive trend of LYR-201 over sham across 24 weeks, though not statistically significant. By week 24, LYR-201 brought improvements in 3 cardinal symptoms (-1.13; P = .0837), SNOT-22 scores (-8.7; P = .1331), percent ethmoid opacification (-6.07; P = .1127), nasal congestion score in patients with moderate to severe nasal congestion score at baseline (-0.33; P = .2159), and nasal polyp score (-0.16; P = .3494).
“These positive results represent a significant milestone in advancing an innovative treatment to CRS patients who suffer from this chronic condition,” said Harlan Waksal, MD, executive chairman at Lyra Therapeutics, in a statement. “It's a proud moment for us and a testament to the dedication of this team and our investigators in the development of this novel therapy.”
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