The non-polyp form of CRS represents approximately 70%-to-90% of CRS patients. The sinuses are lined with a soft, moist layer of mucus-producing tissue, or mucosa. There are two categories of sinusitis: acute and chronic. Acute sinusitis is transient in nature and lasts less than four weeks. Although FESS and BSD can improve symptoms and quality of life, limitations remain. 8226; Additional FESS procedures may be needed. However, each of these treatments has limitations. It is designed for office-based administration performed with topical anesthesia. Each matrix contained 2,500 µg of MF. The trial results indicated low levels of systemically circulated steroid from LYR-210. There were no AEs associated with the matrices that were dislodged. Total Symptom Improvement by SNOT-22 Score in Phase 1 Clinical Trial for LYR-210. ** Significant symptom improvement was achieved in all of the SNOT-22 subdomains at week 24. These patients represent the addressable market for LYR-220. We are currently evaluating the development path for this additional indication. In most cases, the submission of an NDA is subject to a substantial application user fee. The FDA may not grant approval on a timely basis, or at all. The fourth certification described above is known as a paragraph IV certification. Available Information Our Internet address is www.lyratherapeutics.com. We may not be successful in such a transition. Additional sources of financing might not be available on favorable terms, if at all. Our other product candidate, LYR-220, is in pre-clinical development. From time to time, we may publish interim or preliminary data from our clinical trials. Certain legal and political risks are also inherent in foreign operations. Any such delay or rejection could prevent us from commercializing our product candidates. Once disclosed, we are likely to lose trade secret protection. A defendant could also challenge our ownership of patents assigned to us.
