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2/18/2021
and please stand by. Your Oyster Point Pharma fourth quarter 2020 earnings conference call will begin momentarily. Thank you for your patience and please stand by. Thank you. Good evening, and welcome to Oyster Point Pharma's fourth quarter 2020 earnings conference call. My name is Josh, and I will be your operator today. After the company's formal remarks, there will be a question and answer session. At this time, I would like to turn the call over to Mr. Daniel Lochner, Oyster Point Pharma's chief financial officer. Sir, please go ahead.
Good evening, everyone, and welcome to the Oyster Point Pharma fourth quarter earnings conference call for the three months ending December 31, 2020. This evening, we issued a press release containing our fourth quarter financial results and recent business highlights. In addition, our earnings press release and our Form 10-K that we filed with the SEC this evening are available on our website under the Investor and News section at www.oysterpointrx.com. Joining us on our call today are Dr. Jeffrey Now, President and Chief Executive Officer of Oyster Point Pharma, and John Snizerenko, Chief Commercial Officer. Following Dr. Now, John, and my prepared remarks, we will open up the line for questions. This conference call contains forward-looking statements regarding future events and the future performance of OysterPoint Pharma. Forward-looking statements, including statements regarding OysterPoint's possible or assumed future results of operations, expenses and financial position, business strategies and plans, research, development, and commercial plans or expectations, trends, market sizing, competitive position, our belief regarding our clinical trial outcomes, including secondary endpoint analysis, predictions regarding product approvals or the FDA, our efforts to manage the impact of COVID-19, and the industry environment and growth opportunities, among other things. In addition, this conference call discusses products that are under clinical investigation, which have not yet been approved for marketing by the Food and Drug Administration. They are currently limited by federal law to investigational use and no representation is made as to their safety or effectiveness for the purposes for which they're being investigated. These statements are based upon the information available to the company today, and OSHA point assumes no obligation to update these statements as circumstances change. Future events and actual results can differ materially from those projected in the company's forward-looking statements. Additional information concerning risk factors that could cause results to differ materially from our forward-looking statements are described in greater detail under the caption, Risk Factors and the Company's Filings of the SEC, including our annual report on Form 10-K for the year ended December 31, 2020, filed with the SEC on February 18, 2021. I will now turn the call over to Dr. Jeffrey Now, President and Chief Executive Officer of Oyster Point Pharma.
Thank you, Dan. Good evening, everyone, and thank you for joining us on our call today to discuss our fourth quarter 2020 financial results and recent business highlights. As you know, on December 17, 2020, we submitted our NDA for OCO-1 nasal spray with an indication for the treatment of the signs and symptoms of dry eye disease. In the coming days, we expect to hear back from the FDA regarding the acceptance of our NDA for review and the PDUFA date, if accepted. Once we are in receipt of the correspondence from FDA, we will issue a press release announcing the NDA acceptance. In addition to our OCO-1 nasal spray for dry eye disease, we filed an IND in November to evaluate the potential of OCO-1 for the treatment of stage one and stage two neurotrophic keratopathy. We believe that OCO-1's unique mechanism of action of stimulating natural tear film by the trigeminal parasympathetic pathway as seen in preclinical and clinical studies, may be beneficial for patients with corneal epithelial hyperplasia and or punctate keratopathy, as well as those with persistent epithelial defects. We plan to begin enrollment of the phase two Olympia clinical trial in the first half of 2021. As we are preparing for a potential launch, there are a number of major ophthalmology meetings that we plan to attend, either virtually or live in 2021, dependent on the fluent environment in light of the current pandemic. The 2021 Association for Research and Vision and Ophthalmology meeting will be held virtually May 1st through the 7th. OysterPoint's Phase 3 Onset 2 data will be presented at this meeting with the time and date details to be announced. The 2021 Royal Hawaiian Eye meeting at present will be held live from May 8th through the 14th in Maui. The American Society of Cataract and Refractive Surgery is scheduled for July 23rd through the 27th in Las Vegas, and the American Academy of Ophthalmology annual meeting will be held in New Orleans from November 12th through the 15th. We are looking forward to a year where we are able to showcase at the various ophthalmic meetings the data from our clinical development program and highlight what we believe is the strongest data set in the treatment of a real-world population in the dry eye space. We expect 2021 to be an incredible year for the company as we transition from a clinical development company to a commercial organization that remains committed to the research and development of therapies to treat diseases of the ocular surface. We plan on bringing innovative and transformative ocular surface disease treatments to patients and building Oyster Point Pharma into a best-in-class ophthalmology company. I would now like to turn the call over to John Snizerenko, Oyster Point's Chief Commercial Officer to discuss our ongoing preparations for the potential commercial launch of OCO-1 nasal spray in dry eye disease in Q4 2021. Thank you, Jeff.
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