Efficacy and Safety of LYR-210 for the Treatment of Chronic Rhinosinusitis in Adults (ENLIGHTEN 2)

Inclusion Criteria:

• Age ≥18

• Diagnosed as having CRS

• Bilateral ethmoid disease confirmed on CT

• Mean 3 cardinal symptom (3CS) score

• Undergone at least 2 trials of medical treatments in the past

• Has been informed of the nature of the study and provided written informed consent

• Agrees to comply with all study requirements

• If currently on a waiting list for sinonasal surgery, willing to be removed from thewaiting list or have preplanned surgery date cancelled for the duration of thestudy. [Note: this does not preclude a participant from receiving or beingrecommended for sinonasal surgery as rescue treatment during the study].

Exclusion Criteria:

• Inability to tolerate topical anesthesia

• Previous nasal surgery

• Presence of nasal polyp grade 2 or higher

• Seasonal allergic rhinitis

• Perennial rhinitis with symptoms that are well controlled by regular use ofintranasal corticosteroids

• Severe asthma

• History or clinical evidence or suspicion of invasive fungal sinusitis, allergicfungal rhinosinusitis, atrophic rhinitis, or odontogenic sinusitis

• Obstruction preventing proper placement and retention of LYR-210 as seen onendoscopy

• Anatomic variation that, in the opinion of the investigator, would adversely impactplacement of LYR-210 as seen on CT

• Known history of hypersensitivity or intolerance to corticosteroids

• Known history of hypothalamic pituitary adrenal axial dysfunction

• Previous pituitary or adrenal surgery

• Dental procedure/implant on maxillary dentition within 4 weeks of the Screeningvisit.

• Past or present acute or chronic intracranial or orbital complications of CRS

• History or diagnosis (in either eye) of glaucoma or ocular hypertension

• Past or present functional vision in only 1 eye

• Past, present, or planned organ transplant or chemotherapy with immunosuppression

• Currently positive for COVID-19 or residual sinonasal symptoms from a previousCOVID-19 infection

• Pregnant or breast feeding. Females of child-bearing potential must test negativefor pregnancy at the time of screening

• Evidence of disease or condition expected to compromise survival or ability tocomplete follow-up assessments

• Currently participating in an investigational drug or device study

• Determined by the investigator as not suitable to be enrolled