Oyster Point Pharma to Present Data at American Academy of Ophthalmology 2021 Annual Meeting | New


PRINCETON, NJ, November 09, 2021 (GLOBE NEWSWIRE) – Oyster Point Pharma, Inc. (Nasdaq: OYST), a commercial-stage biopharmaceutical company focused on the discovery, development and commercialization of leading pharmaceutical therapies to treat the ophthalmic diseases, today announced several scientific presentations at the 2021 American Academy of Ophthalmology (AAO) annual meeting to be held in New Orleans, LA, November 12-15, 2021.

“The American Academy of Ophthalmology is the world’s largest association of ophthalmologists and surgeons whose mission is to improve lives by advocating for patients and the public, leading ophthalmic education, and advancing the profession of ophthalmology. ‘ophthalmology. Said Marian Macsai, MD, medical director of Oyster Point Pharma. “We are delighted to share a number of presentations of data from company-sponsored clinical trials at this year’s meeting, highlighting the newly approved TYRVAYATM nasal spray (varenicline solution) for the treatment of signs and symptoms of dry eye. “

Documents / Posters

Title: ONSET-2 Phase 3 Trial of OC-01 (Varenicline Solution) Nasal Spray for the Treatment of Signs and Symptoms of Dry Eye Disease Presenter: Marjan Farid, MD Location: Morial Convention Center, Room 255-257 Date / Presentation time: November 14 at 8:48 am-8:55 am CST

Title: Clinical Outcomes of Clinical Signs of OC-01 Nasal Spray in Dry Eye by Basic Stratification Factors – Combined ONSET-1 & -2 Presenter: John D Sheppard MD Location: Morial Convention Center, Hall C (Poster Theater and Lounge ) Date / Time of Presentation: November 14 at 3:45 p.m. – 4:45 p.m. CST

Title: OC-01 (Varenicline Solution) Clinical Signs Nasal Spray Results in Dry Eye Disease by Age and Use of Artificial Tears – A Subgroup Analysis Presenter: Alice T. Epitropoulos, MD Location: Virtual Presentation Date / Time : On demand

About dry eye and the role of the tear film Dry eye is a chronic disease that affects approximately 38 million people in the United States and is increasing in prevalence.1,2 It can cause persistent stinging, scratching, burning sensations, sensitivity to light, blurred vision and eye strain. Dry eye is a multifactorial disease of the ocular surface characterized by rupture of the tear film. The human tear film is a complex mixture of more than 1,500 different proteins, including growth factors and antibodies, as well as many classes of lipids and mucins.3 The natural tear film protects and lubricates the eyes, eliminates particles foreign, contains growth factors and antimicrobial agents. components and creates a smooth surface that forms the primary refractive surface of the eye.

About TYRVAYA â„¢ (varenicline solution) Nasal Spray TYRVAYA (varenicline solution) Nasal Spray 0.03 mg (formerly called nasal spray OC-01) is a highly selective cholinergic agonist that is approved by the FDA to treat signs and symptoms of dry eye as a multidose nasal spray. The parasympathetic nervous system, the body’s “rest and digest” system, controls tear film homeostasis in part through the trigeminal nerve, which is accessible through the nose. The efficacy of TYRVAYA nasal spray in dry eye is believed to be the result of varenicline activity at the heteromeric nicotinic acetylcholine receptor (nACh) subtype (s) where its binding produces agonist activity. and activates the trigeminal parasympathetic pathway resulting in increased basal tear film production as a treatment for dry eye. Varenicline binds with high affinity and selectivity to neuronal nicotinic acetylcholine receptors 4β2, α4α6β2, α3β4, α3α5β4 and α7. The exact mechanism of action is unknown at this time.

Important Safety Information of TYRVAYATM The most common adverse reaction reported in 82% of patients was sneezing. Events reported in 5-16% of patients were cough, throat irritation, and instillation site (nose) irritation. There are no contraindications associated with TYRVAYATM Nasal Spray (varenicline solution).

Please see full prescribing information at www.tyrvaya-pro.com/prescriptioninformation.

About Oyster Point Pharma, Inc. Oyster Point Pharma is a commercial-stage biopharmaceutical company focused on the discovery, development and commercialization of leading pharmaceutical therapies to treat ophthalmic diseases. In October 2021, Oyster Point Pharma received FDA approval for TYRVAYATM nasal spray (varenicline solution) for the treatment of signs and symptoms of dry eye. Oyster Point has a growing portfolio of clinical and preclinical programs and continues to expand its research and development portfolio through internal innovation and external collaborations. Oyster Point continually strives to advance cutting-edge science and provide therapies to address the unmet needs of patients with ophthalmic disease and the eye care professionals who care for them. For more information visit www.oysterpointrx.com and follow @OysterPointRx on Twitter and LinkedIn.

Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 which reflect Oyster Point Pharma’s (the “Company” or “our”) current beliefs, expectations and assumptions regarding the future. of the Company’s business, our future plans and strategies, regulatory approvals, preclinical and clinical results, future financial condition and other future conditions. All statements other than statements of historical fact contained in this press release, including express or implied statements regarding management’s plans and objectives for future operations, future operating results and financial condition, strategy commercial, product candidates, regulatory approvals, anticipated future commercialization of the product, planned preclinical studies and clinical trials, expected results of preclinical studies or clinical trials, and their timing and likelihood of success, costs to commercialize expected research and development, are forward-looking statements. The words “if approved”, “may”, “will”, “should”, “should”, “expect”, “plan”, “anticipate”, “could”, “intend”, “Target”, “project”, “- not all statements contain these identifying words. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to: our plans and potential for success relating to the commercialization of TYRVAYA; the beneficial characteristics, safety, efficacy and therapeutic effects of TYRVAYA and our preclinical and clinical product candidates; our plans for the further development and manufacture of TYRVAYA and our preclinical and clinical candidates, including potential additional indications or disease areas to be assessed and pursued; when to launch our future preclinical studies or clinical trials; uncertainties inherent in pharmaceutical research and development, including the results of preclinical studies and clinical trials and further analysis of existing data; the likelihood of clinical trials demonstrating the safety and efficacy of our product candidates, and other positive results; the timing or likelihood of registrations and regulatory approvals of TYRVAYA and our clinical and preclinical candidates, including in potential additional indications for TYRVAYA and potential filings in other jurisdictions; our plans and ability to obtain or protect intellectual property rights, including extensions of the terms of existing patents, where applicable; our ability to recruit and retain key personnel necessary to develop and market our product candidates, if approved, and to grow our business; existing regulations and regulatory developments in the United States and other jurisdictions; our continued reliance on third parties to conduct preclinical studies and additional clinical trials of our product candidates, and for the manufacture of our product candidates for potential commercialization and for preclinical studies and clinical trials; the impact of the COVID-19 pandemic on our activities, operations and regulatory and clinical development timelines; the accuracy of our estimates of expenses, future revenues, capital requirements and additional financing requirements; our financial performance; market conditions; the adequacy of our existing capital resources to fund our future operating expenses and capital expenditure needs; and other risks described in the “Risk Factors” section included in our public documents that we have filed and will make with the Securities and Exchange Commission (SEC). The Company is providing the information contained in this press release as of this date and does not undertake to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

Investor Contact Tim McCarthy LifeSci Advisors, LLC (212) 915-2564 [email protected]

Media Contact Sheryl Seapy Real Chemistry (213) 262-9390 [email protected]


Scope of the market. 2020 Dry Eye Products Report: A Global Market Analysis for 2019 to 2025. October 2020.Tsubota K, Pflugfelder S, Liu Z, Baudouin C. Defining dry eye from a clinical perspective. Int J Mol Sci. 2020; 21 (23): 1-24. https://pubmed.ncbi.nlm.nih.gov/33291796/Willcox, MD, Argüeso, P., Georgiev, GA, Holopainen, JM, Laurie, GW, Millar, TJ, … & Jones, L. (2017). TFOS DEWS II tear film report. The ocular surface, 15 (3), 366-403.


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