LYR-210 Depot (LYR-210) for Adult Subjects With Chronic Sinusitis (LANTERN Study)

A Phase II, Randomized, Blinded, Sham Procedure-Controlled, Parallel-Group Trial to Evaluate the Efficacy, Safety and Tolerability of LYR-210 in Adult Subjects With Chronic Sinusitis (LANTERN Study)

This is a Phase II, Randomized, Blinded, Sham Procedure-Controlled, Parallel-Group Trial to Evaluate the Efficacy, Safety and Tolerability of LYR-210 in Adult Subjects with Chronic Sinusitis.

LYR-210 is a drug depot, which contains the anti-inflammatory medication mometasone furoate (MF) pre-loaded in a single use applicator. LYR-210 is intended to be placed bilaterally into the sino-nasal passages by an otolaryngologist. Once in place, each LYR-210 drug depot is designed to gradually deliver sustained topical doses of MF to the inflamed mucosal sinus tissue over 24 weeks.

Inclusion Criteria:

• Diagnosis of CS.
• Two trials of medical treatments for CS in the past.
• Minimum CS symptom score.
• Ability to tolerate topical anesthesia.
• Has been informed of the nature of the study and has provided written informed consent as approved by the Institutional Review Board (IRB)/Ethics Committee (EC) of the respective clinical site.
• Agrees to comply with all study requirements.

Exclusion Criteria:

• Have undergone previous sinus surgery.
• Pregnant or breast feeding.
• Known history of hypersensitivity or intolerance to corticosteroids.
• History or clinical evidence or suspicion of invasive fungal sinusitis, allergic fungal rhinosinusitis, or atrophic rhinitis.
• Known history of hypothalamic pituitary adrenal axial dysfunction or having a morning serum cortisol level at screening outside of the normal range.
• Had dental procedure/implant on maxillary dentition within 4 weeks of the Screening visit.
• Past or present functional vision in only one eye.
• Has cataracts
• Past, present, or planned organ transplant or chemotherapy with immunosuppression.
• Currently participating in an investigational drug or device study