Lyra Therapeutics, Inc. (Nasdaq: LYRA) has announced the full enrollment of its pivotal Phase 3 ENLIGHTEN 2 clinical trial, evaluating LYR-210 for the treatment of chronic rhinosinusitis (CRS) in adult patients who have not undergone prior ethmoid sinus surgery. LYR-210 is an investigational bioresorbable nasal implant designed to provide six months of continuous anti-inflammatory medication (mometasone furoate) to the sinonasal passages. Topline results from ENLIGHTEN 2 are expected in Q2 2025.
ENLIGHTEN Pivotal Program Details
The ENLIGHTEN program comprises two Phase 3 clinical trials, ENLIGHTEN 1 and ENLIGHTEN 2, designed to assess the efficacy and safety of LYR-210 in treating CRS. Each trial enrolled approximately 180 CRS patients who had previously failed medical management and had no prior ethmoid sinus surgery. Participants were randomized in a 2:1 ratio to receive either LYR-210 (7500μg mometasone furoate) or a sham control, with a 24-week evaluation period.
About LYR-210
LYR-210 is an investigational product candidate intended for CRS patients who have not responded adequately to existing therapies and require further intervention. Administered via a simple, in-office procedure, the bioresorbable nasal implant delivers continuous anti-inflammatory therapy (mometasone furoate) to the sinonasal passages over six months. The ongoing ENLIGHTEN Phase 3 clinical program is evaluating LYR-210 for patients with standard anatomy, particularly those without prior ethmoid sinus surgery.
Lyra Therapeutics' Perspective
"We are pleased to have fully enrolled the second of our two pivotal trials of LYR-210 in CRS patients, and our team is moving forward expeditiously to report the results in Q2 of next year," said Maria Palasis, Ph.D., President and CEO of Lyra Therapeutics. "We thank the participants and the investigators in the ENLIGHTEN studies who have enabled the evaluation of our technology that could potentially benefit patients with CRS."
