This section highlights FDA-related milestones and regulatory updates for drugs developed by Lyra Therapeutics (LYRA).
Over the past two years, Lyra Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
LYR-210 and LYR-220. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
LYR-210 FDA Regulatory Timeline and Events
LYR-210 is a drug developed by Lyra Therapeutics for the following indication: Chronic Rhinosinusitis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- LYR-210
- Announced Date:
- June 2, 2025
- Indication:
- Chronic Rhinosinusitis
Announcement
Lyra Therapeutics, Inc. announced positive results from the ENLIGHTEN 2 Phase 3 clinical trial of LYR-210 in adult patients with CRS.
AI Summary
Lyra Therapeutics, Inc. announced positive results from its ENLIGHTEN 2 Phase 3 trial for LYR-210, a bioresorbable nasal implant designed to treat chronic rhinosinusitis (CRS) in adults. The study met its primary endpoint by showing a statistically significant improvement in the composite of three key symptoms—nasal obstruction, discharge, and facial pain—at 24 weeks in patients without nasal polyps. Key secondary endpoints, including the SNOT-22 score, also demonstrated significant improvement starting as early as week 4. LYR-210 was well tolerated and had a safety profile similar to the sham control, suggesting it may offer six months of continuous anti-inflammatory relief through a simple in-office procedure.
These promising findings could pave the way for new treatment options for many CRS sufferers. Lyra plans to review the complete dataset to help guide the next steps in the development of LYR-210, potentially benefiting patients who have not responded to standard therapies.
Read Announcement- Drug:
- LYR-210
- Announced Date:
- May 7, 2025
- Indication:
- Chronic Rhinosinusitis
Announcement
Lyra Therapeutics, announced that the Company plans to present results from the 52-week Extension Stage of the ENLIGHTEN 1 Phase 3 study for LYR-210, the Company's lead product candidate for CRS, at the annual Combined Otolaryngology Spring Meetings (COSM 2025) being held May 14-18 in New Orleans.
AI Summary
Lyra Therapeutics announced plans to present key findings from the 52-week Extension Stage of its ENLIGHTEN 1 Phase 3 study at the annual Combined Otolaryngology Spring Meetings (COSM 2025). The study focuses on LYR-210, the company’s lead product candidate for chronic rhinosinusitis (CRS). The upcoming poster presentation, scheduled during the COSM 2025 meeting in New Orleans from May 14-18, will detail how LYR-210 was generally well tolerated over 52 weeks, with no treatment-related serious adverse events reported. It will also highlight the durable symptom control observed even after the cessation of treatment and improvements in symptoms among various patient groups, including those with nasal polyps. This event is an important opportunity for the company to share updated data and further demonstrate the safety profile observed in the Extension Stage, reinforcing LYR-210's potential as a meaningful treatment option for CRS patients.
Read Announcement- Drug:
- LYR-210
- Announced Date:
- September 27, 2024
- Indication:
- Chronic Rhinosinusitis
Announcement
Lyra Therapeutics, announced that the Company will present results from the Phase 3 ENLIGHTEN 1 study for LYR-210, the company's lead product candidate for CRS, at the 70th Annual Meeting of the American Rhinologic Society (ARS), taking place September 27-28 in Miami.
AI Summary
Lyra Therapeutics announced it will present results from its Phase 3 ENLIGHTEN 1 study on LYR-210 at the 70th Annual Meeting of the American Rhinologic Society (ARS) in Miami on September 27-28. LYR-210 is the company’s lead product candidate for chronic rhinosinusitis (CRS) and is designed as a bioabsorbable nasal implant that delivers six months of continuous anti-inflammatory therapy with a single in-office procedure.
The poster presentation, led by Vineeta Belanger, PhD, aims to outline the efficacy and safety data gathered from the pivotal study. These findings may provide important insights into LYR-210's potential to offer a new treatment option for CRS patients, contributing to improved management of this challenging inflammatory condition.
Read Announcement- Drug:
- LYR-210
- Announced Date:
- May 6, 2024
- Indication:
- Chronic Rhinosinusitis
Announcement
Lyra Therapeutics, Inc. announced topline results from the Company's Phase 3 ENLIGHTEN 1 trial evaluating LYR-210 for the treatment of chronic rhinosinusitis (CRS). ENLIGHTEN 1 did not meet its primary endpoint of demonstrating statistically significant improvement compared to sham control in the composite score of the three cardinal symptoms (3CS) of CRS (nasal obstruction, nasal discharge, facial pain/pressure) at 24 weeks.
AI Summary
Lyra Therapeutics, Inc. recently announced topline results from its Phase 3 ENLIGHTEN 1 trial evaluating LYR-210, a bioabsorbable sinonasal implant for treating chronic rhinosinusitis (CRS). The study did not meet its primary endpoint, as LYR-210 failed to show a statistically significant improvement over the sham control in the composite score of three key CRS symptoms—nasal obstruction, nasal discharge, and facial pain/pressure—at 24 weeks. Although both the treatment and control groups showed improvements from baseline, the differences were not enough to reach statistical significance. The company expressed surprise and disappointment with these findings and stated that it will review the full dataset to better understand the outcomes and determine the next steps. Additionally, the trial is ongoing, with further data expected later this year, and a second pivotal Phase 3 trial, ENLIGHTEN 2, is also underway.
Read Announcement
LYR-220 FDA Regulatory Events
LYR-220 is a drug developed by Lyra Therapeutics for the following indication: Chronic rhinosinusitis (CRS).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- LYR-220
- Announced Date:
- September 27, 2024
- Indication:
- Chronic rhinosinusitis (CRS)
Announcement
Lyra Therapeutics, announced that the Company will present additional results from the Phase 2 BEACON study for LYR-220 in adult patients with CRS who have had prior ethmoid sinus surgery at the Annual Meeting of the American Academy of Otolaryngology–Head and Neck Surgery (AAO-HNS), taking place September 28 - October 1 in Miami.
AI Summary
Lyra Therapeutics announced that it will present additional data from the Phase 2 BEACON study for its LYR-220 treatment at the Annual Meeting of the American Academy of Otolaryngology–Head and Neck Surgery (AAO-HNS) in Miami. The study focused on adult patients with chronic rhinosinusitis (CRS) who had previously undergone ethmoid sinus surgery. The new results will shed light on the efficacy and safety of LYR-220, a steroid-eluting sinus insert designed to help improve symptoms like disrupted sleep and reduced sense of smell. The meeting is scheduled from September 28 to October 1, giving experts a valuable opportunity to review the findings. This presentation reinforces Lyra Therapeutics’ commitment to advancing long-acting, anti-inflammatory therapies for CRS patients who have not found relief through traditional treatments.
Read Announcement
