Oyster Point Pharma Announces Patient Savings Program Where Eligible Patients Can Pay as Little as $0 for TYRVAYA™ (varenicline solution) Nasal Spray for the Treatment of The Signs and Symptoms of Dry Eye Disease

Rhea-AI Summary

Oyster Point Pharma has launched TEAMTyrvaya™, a patient support program aimed at making TYRVAYA™ nasal spray accessible for those with dry eye disease. TYRVAYA is the first FDA-approved nasal spray for dry eye symptoms, allowing patients to pay as little as $0 with eligible insurance. The product is a cholinergic agonist that stimulates tear production and is administered twice daily. Approximately 38 million people in the U.S. suffer from dry eye disease. The spray is available via prescription, with each bottle providing 15 days of treatment.

Positive

• Launch of TEAMTyrvaya™ patient support program enhances treatment accessibility for eligible patients.
• First FDA-approved nasal spray for dry eye disease offers a new method of administration.

Negative

• Market competition may affect the uptake of TYRVAYA™ in a growing dry eye market.

• Oyster Point has launched a patient support program called TEAMTyrvaya™
  
  
• TYRVAYA is the first and only nasal spray approved for the treatment of the signs and symptoms of dry eye disease

PRINCETON, N.J., Nov. 04, 2021 (GLOBE NEWSWIRE) -- Oyster Point Pharma, Inc. (Nasdaq: OYST), today announced it has launched a patient support program called TEAMTyrvaya™ where eligible¹ patients can pay as little as $0 for TYRVAYA™ (varenicline solution) Nasal Spray 0.03 mg. The U.S. Food and Drug Administration (FDA), approved TYRVAYA Nasal Spray for the treatment of the signs and symptoms of dry eye disease on October 15, 2021. TYRVAYA Nasal Spray is a highly selective cholinergic agonist delivered twice daily as an aqueous nasal spray into each nostril to activate basal tear production. Nasal spray administration provides a new way to treat dry eye disease without administering medication onto an already irritated ocular surface. In addition, nasal delivery may allow some patients who have difficulty administering topical eye drops to administer independently their prescribed dry eye disease therapy.

John Snisarenko, Chief Commercial Officer of Oyster Point Pharma stated, "Oyster Point Pharma is committed to helping people with dry eye disease have access to the treatments they need and therefore have established comprehensive patient affordability and access programs, including a co-pay savings offer to allow eligible patients with commercial insurance to pay as little as $0 for TYRVAYA Nasal Spray." Mr. Snisarenko added, "We are working closely with the eye care provider community to share these resources with their constituents and help people with dry eye disease have access to the resources they need." For more information on the TEAMTyrvaya patient support program and how to enroll, please visit www.Tyrvaya-Pro.com.

TYRVAYA Nasal Spray will be available with a prescription in cartons containing two multidose nasal spray bottles. Each nasal spray bottle covers treatment for 15 days, administered twice daily into each nostril. Samples that provide 15 days of treatment will also be made available to eye care providers.

About Dry Eye Disease and the Role of Tear Film
Dry eye disease is a chronic condition that impacts an estimated 38 million people in the U.S. and is growing in prevalence^2,3. It can cause persistent stinging, scratching, burning sensations, sensitivity to light, blurred vision, and eye fatigue. Dry eye disease is a multifactorial disease of the ocular surface characterized by disruption of the tear film. Human tear film is a complex mixture of more than 1,500 different proteins, including growth factors and antibodies, as well as numerous classes of lipids and mucins⁴. Natural tear film protects and lubricates the eyes, washes away foreign particles, contains growth factors and antimicrobial components, and creates a smooth surface that forms the primary refractive surface of the eye.

About TYRVAYA™ (varenicline solution) Nasal Spray
TYRVAYA (varenicline solution) Nasal Spray 0.03 mg is a highly selective cholinergic agonist that is FDA-approved to treat the signs and symptoms of dry eye disease as a multidose nasal spray. The parasympathetic nervous system, the “rest and digest” system of the body, controls tear film homeostasis partially via the trigeminal nerve, which is accessible within the nose. The efficacy of TYRVAYA Nasal Spray in dry eye disease is believed to be the result of varenicline's activity at heteromeric sub-type(s) of the nicotinic acetylcholine (nACh) receptor where its binding produces agonist activity and activates the trigeminal parasympathetic pathway resulting in increased production of basal tear film as a treatment for dry eye disease. Varenicline binds with high affinity and selectivity at human α4β2, α4α6β2, α3β4, α3α5β4 and α7 neuronal nicotinic acetylcholine receptors. The exact mechanism of action is unknown at this time.

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

Please see full Prescribing Information at www.tyrvaya-pro.com/prescribinginformation.

About Oyster Point Pharma, Inc.
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™ (varenicline solution) Nasal Spray for the treatment of the signs and symptoms of dry eye disease. Oyster Point has a growing pipeline of clinical and pre-clinical programs and continues to expand its research and development pipeline through internal innovation and external collaborations. Oyster Point is continuously striving to advance breakthrough science and deliver therapies seeking to address the unmet needs of patients with ophthalmic disease and the eye care professionals who take care of 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 that reflect the current beliefs, expectations and assumptions of Oyster Point Pharma (the “Company” or “our”) 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 facts contained in this press release, including express or implied statements regarding plans and objectives of management for future operations, future results of operations and financial position, business strategy, product candidates, regulatory approvals, planned future product commercialization, planned preclinical studies and clinical trials, expected results of preclinical studies or clinical trials, and their timing and likelihood of success, expected research and development commercialization costs, are forward-looking statements. The words “if approved,” “may,” “will,” “should,” “would,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, among other things: our plans and potential for success relating to commercializing TYRVAYA; the beneficial characteristics, safety, efficacy and therapeutic effects of TYRVAYA and our preclinical and clinical product candidates; our plans relating to the further development and manufacturing of TYRVAYA and our preclinical and clinical candidates, including potential additional indications or disease areas to be evaluated and pursued; the timing of initiation of our future preclinical studies or clinical trials; the uncertainties inherent in pharmaceutical research and development, including preclinical study and clinical trial results and additional analysis of existing data; the likelihood of clinical trials demonstrating safety and efficacy of our product candidates, and other positive results; the timing or likelihood of regulatory filings and approvals TYRVAYA and our clinical and preclinical candidates, including in potential additional indications for TYRVAYA and potential filings in additional jurisdictions; our plans and ability to obtain or protect intellectual property rights including extensions of existing patent terms where available; our ability to recruit and retain key personnel needed to develop and commercialize our product candidates, if approved, and to grow our company; existing regulations and regulatory developments in the United States and other jurisdictions; our continued reliance on third parties to conduct additional preclinical studies and 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 business, operations, and regulatory and clinical development timelines; the accuracy of our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; our financial performance; market conditions; the sufficiency of our existing capital resources to fund our future operating expenses and capital expenditure requirements; and other risks described in the “Risk Factors” section included in our public filings that we have made and will make with the Securities and Exchange Commission (SEC). The Company is providing the information in this press release as of this date and does not undertake any obligation 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
investors@oysterpointrx.com

Media Contact
Sheryl Seapy
Real Chemistry
(213) 262-9390
sseapy@realchemistry.com

References:

1. Limitations apply. Eligible, commercially insured patients with coverage for Tyrvaya™ pay as little as $0, up to a savings maximum of $275 for each 30-day prescription. Patient is responsible for any out-of-pocket costs once monthly savings limit is reached. Eligible, commercially insured patients awaiting a coverage decision from their insurance plan pay $10 for each 30-day prescription as a bridge to coverage. The bridge to coverage $10 offer expires 07/31/2022. Offer not valid under Medicare, Medicaid, or any other federal or state program. Offer not valid for non-insured/cash-paying patients. Oyster Point reserves the right to change or discontinue this offer at any time, without notice. See complete Terms & Conditions for details.
   
   
2. Market-Scope. 2020 Dry Eye Products Report: 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/
   
   
4. Willcox, M. D., Argüeso, P., Georgiev, G. A., Holopainen, J. M., Laurie, G. W., Millar, T. J., ... & Jones, L. (2017). TFOS DEWS II tear film report. The ocular surface, 15(3), 366-403.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/c747ed0d-d6b9-4230-ba9f-282adc1b19b7

FAQ

What is the TEAMTyrvaya™ program launched by Oyster Point Pharma?

The TEAMTyrvaya™ program offers patient support to help individuals with dry eye disease access TYRVAYA™ nasal spray, potentially for as little as $0.

What is TYRVAYA™ and how is it administered?

TYRVAYA™ is a nasal spray approved for treating dry eye disease, administered twice daily into each nostril.

When did the FDA approve TYRVAYA™ for dry eye disease?

The FDA approved TYRVAYA™ nasal spray on October 15, 2021.

How many people in the U.S. are affected by dry eye disease?

An estimated 38 million people in the U.S. suffer from dry eye disease.

What are the common side effects of TYRVAYA™?

The most common side effect of TYRVAYA™ is sneezing, which was reported in 82% of patients.