Oyster Point Pharma announces that TYRVAYA® will be covered by the

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PRINCETON, NJ, Aug. 17, 2022 (GLOBE NEWSWIRE) — Oyster Point Pharma, Inc. (Nasdaq: OYST), (“Oyster Point Pharma” or “the Company”), a discovery-focused, commercial-stage biopharmaceutical company, the development and commercialization of first-in-class pharmaceutical therapies to treat ophthalmic diseases, today announced that the largest Medicare pharmacy benefits manager in the United States will add TYRVAYA® Nasal Spray on its Medicare Part D forms, effective September 1, 2022.

“We are thrilled to announce this important milestone that will further expand patient access and enable eye care professionals to prescribe TYRVAYA on an ongoing basis,” said Jeffrey Nau, Ph.D., MMS, President and Chief the management of Oyster Point Pharma. “Nearly half of total dry eye prescriptions in the United States are covered by Medicare, and we believe TYRVAYA offers a truly compelling treatment option. We are committed to increasing patient access and look forward to continued engagement with Medicare Part D health plans.”

About Oyster Point Pharma

Oyster Point Pharma is a commercial-stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class pharmaceutical therapies to treat ophthalmic diseases. In October 2021, Oyster Point Pharma received FDA approval for TYRVAYA Nasal Spray (Varenicline Solution) for the treatment of signs and symptoms of dry eye disease. Oyster Point Pharma has a growing pipeline of clinical and preclinical programs and continues to expand its research and development pipeline through internal innovation and external collaborations. Oyster Point Pharma continually strives to advance cutting-edge science and deliver therapies aimed at addressing the unmet needs of patients with ophthalmic diseases and the eye care professionals who care for them. For more information, visit www.oysterpointrx.com and follow @OysterPointRx on Twitter and LinkedIn.

About TYRVAYA® (varenicline solution) nasal spray

TYRVAYA (Varenicline Solution) Nasal Spray 0.03mg is a highly selective cholinergic agonist cleared by the FDA to treat the signs and symptoms of dry eye in the form of a multidose nasal spray. The parasympathetic nervous system, the body’s “rest and digest” system, controls tear film homeostasis in part via the trigeminal nerve, which is accessible through the nose. The efficacy of TYRVAYA Nasal Spray in dry eye disease is thought to be the result of the activity of varenicline on heteromeric subtypes of the nicotinic acetylcholine receptor (nACh) 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 human neuronal nicotinic receptors α4β2, α4α6β2, α3β4, α3α5β4 and α7. The exact mechanism of action is unknown at this time.

Important Safety Information for TYRVAYA®

The most frequently reported side effect 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 TYRVAYA Nasal Spray (Varenicline Solution). Please see full prescribing information at www.tyrvaya-pro.com/prescribeinformation.

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 tear film breakdown. The human tear film is a complex mixture of over 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, removes foreign particles, contains growth factors and antimicrobial components, and creates a smooth surface that forms the primary refractive surface of the eye.

Forward-looking statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements regarding the future of the Company’s business. , the Company’s future plans and strategies, business opportunities, interactions with regulators, regulatory approvals, preclinical and clinical results, future financial condition, timing of preclinical and clinical trials, including data from such trials and other expected milestones, the timing of insurance coverage determinations for TYRVAYA Nasal Spray and the potential therapeutic and clinical benefits of the Company’s product candidates and other future terms. The words “if approved”, “may”, “shall”, “should”, “would”, “expect”, “plan”, “anticipate”, “anticipate”, “could”, “has intention”, “target”, “plan”, “contemplate”, “believe”, “estimate”, “predict”, “potential” or “continue” or the negative form of these terms or other similar expressions are intended to identify forward-looking statements, although all forward-looking statements contain these identifying words. The reader is cautioned not to rely on these forward-looking statements. All forward-looking statements contained in this press release are based on the Company’s current expectations and assumptions and are subject to a number of risks, uncertainties and assumptions, including, among others: the Company’s plans and its potential for success in marketing TYRVAYA, and the availability and sufficiency of third-party payment coverage and reimbursement in connection with TYRVAYA; the Company’s estimates associated with the Company’s plan to rationalize operating expenses, including the related workforce reduction, and the resulting cost savings benefits the Company expects to realize; the beneficial characteristics, safety, efficacy and therapeutic effects of TYRVAYA and the Company’s preclinical and clinical product candidates; the Company’s plans for the development and manufacturing of TYRVAYA and its preclinical and clinical candidates, including potential additional indications or disease areas to be evaluated and pursued; the timing of the launch of the Company’s future preclinical studies or clinical trials; the uncertainties inherent in pharmaceutical research and development, including the likelihood of positive preclinical study results and the likelihood of clinical trials demonstrating the safety and efficacy of the Company’s products or product candidates; the timing or likelihood of filings and regulatory approvals of TYRVAYA and our clinical and preclinical candidates, including in potential additional indications for TYRVAYA and potential filings in other jurisdictions; the prevalence of dry eye disease and neurotrophic keratopathy (NK) and the size of market opportunities for the Company’s product candidates; the potential benefits expected from strategic collaborations with third parties and the Company’s ability to attract employees with development, regulatory and commercialization expertise; existing regulations and regulatory developments in the United States and other jurisdictions; the Company’s plans and ability to obtain or protect intellectual property rights worldwide, including term extensions of existing patents, if any; the Company’s continued reliance on third parties to conduct additional preclinical studies and clinical trials on its product candidates, and for the manufacture of its products and product candidates; economic factors, such as interest rate and currency exchange rate fluctuations; manufacturing difficulties or delays, either internally or within the supply chain; product efficacy or safety issues resulting in product recalls or regulatory action; financial instability of international economies and legal systems and sovereign risk; risks related to the impact of the global COVID-19 pandemic, such as the extent and duration of the outbreak, government actions and restrictive measures implemented in response, significant delays and cancellations of proceedings medical, supply chain disruptions and other impacts on the business, or the Company’s ability to execute business continuity plans, as a result of the COVID-19 pandemic; the Company’s ability to recruit and retain key personnel necessary to develop and commercialize its products and product candidates, and to grow the Company; the accuracy of the Company’s estimates of expenses, future revenues, capital requirements and additional funding requirements; the financial performance of the Company; market conditions; the adequacy of the Company’s existing capital resources to fund its future operating expenses and capital expenditure requirements; and the Company’s expectations regarding the period during which it will be considered an emerging growth company under the JOBS law. A list and additional descriptions of these risks, uncertainties and other factors can be found in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021, including in the sections titled “Special Note Regarding forward-looking statements”. and “Item 1A. Risk Factors,” and in the company’s subsequent quarterly reports on Form 10-Q and in other filings it makes from time to time with the Securities and Exchange Commission. Copies of these filings are available online at www.oysterpointrx.com. Any forward-looking statements made in this press release speak only as of the date of this release. The Company does not undertake to update forward-looking statements as a result of new information or future events or developments, except as required by law. No representation or warranty (express or implied) is made as to the accuracy of these forward-looking statements.

References:

  1. Wirta, D., Vollmer, P., Paauw, J., Chiu, KH, Henry, E., Striffler, K., … & ONSET-2 Study Group. (2021). Efficacy and safety of OC-01 (varenicline) nasal spray on signs and symptoms of dry eye disease: the randomized phase 3 ONSET-2 trial. Ophthalmology. https://doi.org/10.1016/j.ophtha.2021.11.004
  2. Market reach. Dry Eye Products Report 2020: A Global Market Analysis for 2019 to 2025. October 2020.
  3. 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/

Contact Investor
Arty Ahmed
(646) 436-4702
[email protected]

Media Contact
Karen Castillo-Paff
(347) 920-0248
[email protected]

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