Good morning. Welcome to Lyra Therapeutics' Conference Call and webcast to discuss top-line results for Enlightened II phase III trial of LYR-210 in chronic rhinosinusitis. My name is Kevin from Notify Conference Call Service, and I'll be your operator today. This webcast is being recorded. This webcast will be available on Lyra's website for a limited time. Currently, all participants are on a listen-only mode. Earlier this morning, Lyra announced results from Enlightened II phase III trial in a press release. The press release is available on the investor relations page of the company's website at www.lyratherapeutics.com. On this conference call today, members of Lyra's management will make prepared remarks about the Enlightened II phase III trial results with the accompanying slide presentation and the webcast. Today's speakers from Lyra Therapeutics will be Dr. Maria Palasis, President and CEO, and Jason Cavalier, CFO. Following the prepared remarks from Dr. Palasis, we will have a Q&A session. To ask a question at that time, please press star one one on your phone. I will now turn the call over to Mr. Cavalier.
Good morning. During the course of this call, we expect to make forward-looking statements, including statements related to the clinical development of the company's product candidates, business strategy, potential regulatory submissions, and potential commercial plans for its candidates, including estimated addressable market opportunity. These forward-looking statements are based on the company's current expectations and inherently involve risks and uncertainties. Lyra's actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties. Factors that would cause results to be different from these statements include factors that the company describes in the section entitled Risk Factors in the company's quarterly report on Form 10-Q filed with the SEC on May 6, 2025, and its other filings with the SEC. I will now turn the call over to Dr. Palasis.
Good morning. We are very excited to share the positive results from the phase III Enlightened II trial, which evaluated LYR-210 for the treatment of chronic rhinosinusitis, or CRS. Before I take you through the presentation, I want to take a moment to thank our employees for their perseverance and dedication to the continued development of LYR-210 following the Enlightened I trial setback in May 2024. In addition, I want to thank our investigators and patients upfront. Their continued belief in the potential of LYR-210 allowed us to complete the Enlightened II study and collect the data that I am sharing with you today. We will start on slide three to briefly discuss CRS for those unfamiliar with this disease. CRS is characterized by inflammation that is localized within the nasal sinuses. It is widespread and challenging, with approximately eight million patients treated annually in the U.S. alone.
50% of these patients, which amounts to four million patients annually, fail today's available medical therapy and represent our market opportunity. It's estimated that the annual healthcare expenditures related to CRS are approximately $60 billion. Generally speaking, CRS has two phenotypes: patients without nasal polyps, which represent about 70% of the market, and patients with nasal polyps, which represents the remaining 30% of the market. Patients with CRS experience chronic nasal obstruction and congestion, facial pain and pressure, nasal discharge, and reduced sense of smell. These symptoms are referred to as the cardinal symptoms of CRS, and they are relentless and debilitating to patients in their daily lives. On slide four, I will briefly review our technology and product candidates. Our novel technology is an engineered elastomeric matrix that is designed to dynamically conform to the anatomy of the sinonasal passages and is designed to provide long-acting localized drug therapy.
Our lead product candidate is LYR-210, which is the smaller version of our product candidate. It's designed to accommodate patients with a narrow ethmoid cavity. LYR-210 is formulated to deliver 7,500 micrograms of mometasone furoate, a well-known anti-inflammatory steroid, over 24 weeks. Upon completion of our phase II dose-ranging study, LYR-210 was studied in our pivotal phase III Enlightened program, which we are sharing today. We have designed LYR-210 to be the new standard of care for CRS patients that have failed medical management. Within the CRS treatment community, it's well established that steroids work and are the mainstay of treatment. However, these treatments are inadequate for many patients due to limitations in delivery and administration. Oral steroids have well-known systemic safety issues, and steroid nasal sprays don't reach the site of inflammation that is deep within the sinuses.
They don't reside in the local tissue for long periods of time and are dependent on daily patient adherence, which can be challenging for these patients. Lyra's product candidates are designed to address these limitations, and if approved, we believe that LYR-210 is positioned to be the first long-acting product for CRS designed to provide six months of therapy with a single administration. Moving to slide five, the Enlightened program consists of two phase III clinical trials, Enlightened I and Enlightened II, to evaluate the efficacy and safety of LYR-210 for the treatment of CRS. Each trial was designed to evaluate approximately 180 CRS patients who have failed medical management and who have not had ethmoid sinus surgery, randomized two-to-one to either 210 or sham procedure control over 24 weeks.
An important difference between the two trials was that Enlightened I had a 28-week extension stage where patients continued to be blinded to treatment and was intended to demonstrate safety in repeat usage as well as duration of effect, data for which we have previously disclosed. In addition, the sham patients at 24 weeks crossed over in treatment. While the Enlightened program included patients with and without nasal polyps, it's important to note that the primary endpoint was a change from baseline in the three cardinal symptoms, or 3CS, at 24 weeks in patients without nasal polyps. Key secondary endpoints include a change from baseline in the three cardinal symptoms and SNOT-22 score at week 24 for the full population of patients with and without nasal polyps.