Charting a New Course for CRS Treatment
LYR-210 in ENLIGHTEN I Phase 3 Study

April 22, 2022
Randall A. Ow, MD, FACS, FAAOA
Physician Sacramento Ear, Nose & Throat

Millions of patients with chronic rhinosinusitis (CRS) reach a crossroads. They haven’t had success with available medical treatment options and are now faced with a decision of whether to try endoscopic sinus surgery to help alleviate symptoms. While surgery can help some patients, it’s not an ideal solution for everyone. Of the four million patients who experience limited or no benefit from medical therapy for CRS, only about 10% opt for surgery. Even if a patient does choose sinus surgery, he or she will still need medical management because the underlying cause of inflammation is not eliminated. It can also be disheartening for those considering surgery to know that 20% who have an initial sinus surgery will go on to have a follow-up surgery. All said, there is a vast population for whom current interventions for CRS fail to hit the mark.

Lyra Therapeutics’ lead product candidate, LYR-210, is an investigational treatment for sufferers of chronic rhinosinusitis that recently entered a Phase 3 clinical trial called the ENLIGHTEN study. LYR-210 may be an effective, in-office alternative for CRS patients currently underserved by medical treatments and facing sinus surgery as their next option.

LYR-210 is an implantable drug matrix shown in earlier clinical trials to be easily placed and well-tolerated by patients. The unique matrix allows for local, long-acting delivery of mometasone furoate, an approved anti-inflammatory drug agent used widely in the nose and lungs. The LYR-210 matrix is designed to deliver a steady amount of drug to the locally inflamed sinus tissues for up to six months. LYR-210 is placed in the sinuses in a short office visit, and patients can return to their daily activities immediately after placement.

Building on the positive Phase 2 results from the LANTERN study of LYR-210 in CRS patients, Lyra Therapeutics has advanced LYR-210 into a Phase 3 clinical program. The Phase 3 ENLIGHTEN I trial of LYR-210 will include 180 patients who have CRS, continue to suffer despite medical management, and have not had sinus surgery. The trial is designed to provide efficacy and safety information over six months, as well as to assess repeat use of the drug matrix and the duration of benefit following its removal.

It is well recognized by the treatment community that many patients have been resigned to living with the symptoms of CRS and are not comfortable, ready, or willing to have sinus surgery. With limited treatment options available, LYR-210 may have the potential to offer another future pathway when these patients find themselves needing to make a choice between surgery, or no surgery.

Sustained drug delivery at difficult-to-access nasal inflammation sites potentially enables the right drug to get to the right place for the right amount of time. The ENLIGHTEN clinical trial program may demonstrate that LYR-210 can deliver an approved anti-inflammatory drug agent to the epicenter of CRS disease in the sinuses.

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