About Us | ScientistOYST Oyster Point Pharma Inc.
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
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Varenicline (OC-01)
Dry eye disease
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PDUFA
PDUFA
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Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
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Varenicline (OC-01) - OLYMPIA
Neurotrophic Keratitis (NK)
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Phase 2
Phase 2
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Phase 2 commencement of enrollment announced June 21, 2021.
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Varenicline (OC-01)
Dry eye disease
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Phase 2
Phase 2
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Phase 2 top-line data met primary endpoint - January 12, 2020.
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Latest News
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PRINCETON, N.J., Aug. 04, 2021 (GLOBE NEWSWIRE) -- Oyster Point Pharma, Inc. (NASDAQ:OYST), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class pharmaceutical therapies to treat ocular surface diseases, today announced that it will report second quarter 2021 financial results on Thursday, August 5, 2021, after the market close. The announcement will be followed by a live audio webcast and conference call at 4:30 p.m. Eastern Time.
Conference Call Details
To access the live call by phone, please dial (855) 548-1220 (US/Canada) or (602) 563-8619 (International). The conference ID number is 2278335. A telephone replay will be available for approximately 7 days following the live conference call. To access the telephone replay, please dial (855) 859-2056 (US/Canada) or (404) 537-3406 (International). The conference ID number is 2278335.Webcast Details
The webcast will be made available on the company's website at www.oysterpointrx.com under the "Events & Presentations" section.About Oyster Point Pharma
Oyster Point Pharma is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class pharmaceutical therapies to treat ophthalmic diseases. Oyster Point Pharma's lead clinical program is focused on the development of OC-01 (varenicline) nasal spray, a highly selective cholinergic agonist, being developed as a preservative-free nasal spray to treat the signs and symptoms of dry eye disease and neurotrophic keratopathy. In December 2020, Oyster Point submitted to the U.S. Food and Drug Administration (FDA) a New Drug Application (NDA) for OC-01 (varenicline) nasal spray for the treatment of signs and symptoms of dry eye disease. The Prescription Drug User Fee Act (PDUFA) target action date is October 17, 2021, with a planned U.S. launch of OC-01 (varenicline) nasal spray in the fourth quarter of 2021, if approved by the FDA. Oyster Point continues to expand its research and development pipeline through internal innovation and external collaborations with a goal to bring transformative therapies to patients and the eye care providers that take care of them.About Dry Eye Disease
Dry eye disease is a chronic, progressive condition that impacts more than 30 million people in the United States and is growing in prevalence. An estimated 16 million adults in the U.S. have been diagnosed with dry eye disease, a multifactorial condition of the ocular surface characterized by disruption of the tear film. A healthy tear film protects and lubricates the eyes, washes away foreign particles, contains growth factors and antimicrobial components to reduce the risk of infection, and creates a smooth surface that contributes refractive power for clear vision. Dry eye disease can have a significant impact on a person's day-to-day quality of life, as it can cause persistent stinging, scratching, burning sensations, sensitivity to light, blurred vision and eye fatigue. Despite the large prevalence of dry eye and the burden of the disease, there remains a significant unmet need for effective therapies.Investor Contact:
Tim McCarthy
LifeSci Advisors, LLC
(212) 915-2564
[email protected]Media Contact:
Sheryl Seapy, Real Chemistry
(213) 262-9390
[email protected]
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PRINCETON, N.J., Aug. 02, 2021 (GLOBE NEWSWIRE) -- Oyster Point Pharma, Inc., (NASDAQ:OYST), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class pharmaceutical therapies to treat ophthalmic diseases, today announced that the Compensation Committee of its Board of Directors granted inducement non-qualified stock options to purchase an aggregate of 93,600 shares of common stock to 58 new employees, pursuant to the Oyster Point Pharma, Inc., 2021 Inducement Incentive Plan.
Each stock option has an exercise price per share equal to $14.11 per share, Oyster Point's closing trading price on the grant date, and will vest over four years, with 1/4th of the underlying shares vesting on the first year anniversary of the applicable vesting date and 1/36th of the remaining underlying shares vesting on each monthly anniversary thereafter, subject to the new employee's continued service relationship with Oyster Point through the applicable vesting dates.
The Compensation Committee of Oyster Point's Board of Directors approved the awards as an inducement material to the new employees' employment in accordance with NASDAQ Listing Rule 5635(c)(4).
About Oyster Point Pharma, Inc.
Oyster Point Pharma is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class pharmaceutical therapies to treat ophthalmic diseases. Oyster Point Pharma's lead clinical program is focused on the development of OC-01 (varenicline) nasal spray, a highly selective cholinergic agonist, being developed as a preservative-free nasal spray to treat the signs and symptoms of dry eye disease and neurotrophic keratopathy. In December 2020, Oyster Point submitted to the U.S. Food and Drug Administration (FDA) a New Drug Application (NDA) for OC-01 (varenicline) nasal spray for the treatment of signs and symptoms of dry eye disease. The Prescription Drug User Fee Act (PDUFA) target action date is October 17, 2021, with a planned U.S. launch of OC-01 (varenicline) nasal spray in the fourth quarter of 2021, if approved by the FDA. Oyster Point continues to expand its research and development pipeline through internal innovation and external collaborations with a goal to bring transformative therapies to patients and the eye care providers that take care of them.
Investor Contact:
Tim McCarthy
LifeSci Advisors, LLC
(212) 915-2564
[email protected]Media Contact:
Sheryl Seapy, Real Chemistry
(213) 262-9390
[email protected] -
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PRINCETON, N.J., Aug. 02, 2021 (GLOBE NEWSWIRE) -- Oyster Point Pharma, Inc. (NASDAQ:OYST), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class pharmaceutical therapies to treat ophthalmic diseases, today announced the appointment of a new Director and Chairperson to its Board of Directors.
The Oyster Point Pharma Board of Directors is pleased to announce the appointment of Donald Santel as non-executive Chairperson and a Director of the Company and a member of the Compensation Committee. Don joined the Board on July 30, 2021, and will take over as Chairperson as Ali Behbahani, M.D. steps down as Chairperson, remaining a Director of the company.
"We are excited and honored to welcome Don to our Board of Directors as we prepare for the potential approval and launch of our first commercial product at Oyster Point Pharma," said President and CEO Jeffrey Nau, Ph.D., M.M.S. "Don has extensive experience running companies in the pharmaceutical space. We look forward to his insights and contributions, including his leadership as Chairperson, as Oyster Point works to bring transformative therapies to patients with ophthalmic diseases."
"I am excited to join a company that is focused on becoming a leader in developing therapies for the ocular surface and anterior segment," said Donald Santel. "I look forward to working closely with Jeff and the rest of the Board as they build this company in the coming years to bring transformative therapies to patients and the eye care providers who take care of them."
About Donald Santel
Donald Santel served as Executive Chairman of Adicet Bio, Inc., a private allogeneic cell therapy oncology company, from October 2017 through its reverse merger with resTORbio, Inc. in September 2020. From March 2018 through April 2019, Mr. Santel also served as Adicet Bio's interim Chief Executive Officer. He previously served as Chief Executive Officer of Hyperion Therapeutics, a public biopharmaceutical company, from June 2008 until the sale of the company to Horizon Pharma in May 2015, and was a member of Hyperion's board of directors from March 2007 through the company's sale. Previously, Mr. Santel was a co-founder, member of the board of directors and the Chief Executive Officer of CoTherix, Inc., from January 2000 through its sale to Actelion in January 2007. Prior to joining CoTherix, Mr. Santel was employed by several medical device companies, including Cardiac Pathways Corporation (acquired by Boston Scientific) and Medtronic, Inc. Mr. Santel has served as chairman and independent director of Ocelot Bio, Inc., a private biopharmaceutical company, since June 2021. Mr. Santel has also served as an independent director of Consonance-HFW Acquisition Corporation since November 2020. Mr. Santel previously served on the board of directors and the audit and compensation committees of Anthera Pharmaceuticals, Inc. and as a director of ChemGenex Pharmaceuticals, Inc., each a biotechnology company.About Oyster Point Pharma
Oyster Point Pharma is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class pharmaceutical therapies to treat ophthalmic diseases. Oyster Point Pharma's lead clinical program is focused on the development of OC-01 (varenicline) nasal spray, a highly selective cholinergic agonist, being developed as a preservative-free nasal spray to treat the signs and symptoms of dry eye disease and neurotrophic keratopathy. In December 2020, Oyster Point submitted to the U.S. Food and Drug Administration (FDA) a New Drug Application (NDA) for OC-01 (varenicline) nasal spray for the treatment of signs and symptoms of dry eye disease. The Prescription Drug User Fee Act (PDUFA) target action date is October 17, 2021, with a planned U.S. launch of OC-01 (varenicline) nasal spray in the fourth quarter of 2021, if approved by the FDA. Oyster Point continues to expand its research and development pipeline through internal innovation and external collaborations with a goal to bring transformative therapies to patients and the eye care providers that take care of them.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations and assumptions and on information currently available to us. The forward-looking statements in this press release represent our views as of the date of this press release. These statements may include but are not limited to express or implied statements regarding potential marketing approvals for OC-01 or regarding other future events, including future development and commercialization plans. Although we believe the expectations reflected in such forward-looking statements are reasonable, we can give no assurance that such expectations will prove to be correct. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Important factors that could cause our actual results to differ materially include our ability to obtain and maintain regulatory approvals of our product candidates; our plans relating to commercializing our product candidates, if approved, including the geographic areas of focus and sales strategy; the success of competing therapies that are or may become available; the beneficial characteristics, safety, efficacy and therapeutic effects of our product candidates, and other factors as detailed from time to time in the "Risk Factors" section in reports we file with the Securities and Exchange Commission, copies of which are posted on our website and are available from us without charge. However, new risk factors and uncertainties may emerge from time to time, and it is not possible to predict all risk factors and uncertainties.Investor Contact:
Tim McCarthy
LifeSci Advisors, LLC
(212) 915-2564
[email protected]Media Contact:
Sheryl Seapy, W2O Group
(213) 262-9390
[email protected] -
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- Administration of OC-01 (varenicline) nasal spray to non-human primates was observed to inhibit viral replication in the nose within 24 hours of infectious SARS-CoV-2 challenge with absence of subgenomic RNA at Day 3 and Day 5 post-challenge
- Varenicline inhibits cellular entry and replication of SARS-CoV-2 and its alpha and beta variants in multiple human cell types
- Simpinicline inhibits cellular entry and replication of SARS-CoV-2 alpha variant in Calu-3 human cells with additional variants under investigation
- Oyster Point Pharma collaborates with the Trudeau Institute for in vitro testing of varenicline, the active ingredient in OC-01 nasal spray and simpinicline, the active ingredient in OC-02 nasal spray
- Oyster Point Pharma plans to present data at the upcoming Analyst Day, scheduled for July 15, 2021
PRINCETON, N.J., July 01, 2021 (GLOBE NEWSWIRE) -- Oyster Point Pharma, Inc. (NASDAQ:OYST), today announced preclinical data in non-human primates and in vitro models evaluating OC-01 (varenicline) nasal spray against SARS-CoV-2 and the alpha and beta variants, the viruses that cause COVID-19 disease. Administration of OC-01 (varenicline) nasal spray, a highly selective nicotinic acetylcholine receptor agonist, protected rhesus macaques against SARS-CoV-2 nasal infection. The results were published on the preprint server bioRxiv (https://biorxiv.org/cgi/content/short/2021.06.29.450426v1).
"We believe this is the first in vivo and in vitro data illustrating a nicotinic acetylcholine receptor agonists' potential to inhibit viral entry and disrupt replication of the SARS-CoV-2 virus and variants," said Jeffrey Nau, PhD, MMS, president and CEO of Oyster Point. "We believe that OC-01 (varenicline) nasal spray has the potential to complement the current global vaccination strategy and prevent infection and reduce transmission of the SARS-CoV-2 virus with a mechanism of action that may have broad activity across multiple variants."
On Day 1, using a viral infection model and following two administrations of 100 µl of OC-01 (varenicline) nasal spray (0.6 mg/ml varenicline) into each nostril, animals were challenged with a very high viral inoculum (approximately 70 thousand plaque-forming units) of active SARS-CoV-2, via both intranasal (nose) and intratracheal (lung) routes. Animals then received two additional administrations of OC-01 (varenicline) nasal spray into each nostril on Day 1, followed by four times daily for the following four days. Administration of OC-01 (varenicline) nasal spray resulted in inhibition of cellular entry and replication of SARS-CoV-2, illustrated by a decrease of detectable SARS-CoV-2 subgenomic RNA (sgRNA) by approximately 2 logs compared to controls with complete absence in all animals at 3 days and 5 days post-challenge. In control animals treated with the same lot of virus inoculum, nasal swabs reached a peak of approximately 10 million SARS-CoV-2 sgRNA copies within two days of viral challenge and were present throughout the course of the study. The absence of sgRNA indicates that the SARS-CoV-2 virus had not significantly infected nasal mucosa cells to start the transcription process of building new infectious virions. The absence of sgRNA following this very high viral inoculum also suggests the possibility of transmission may be substantially reduced after treatment with OC-01 (varenicline) nasal spray.
SARS-CoV-2 has been shown to predominantly enter the human body via nasal epithelial cells1, specifically ciliated and mucous secreting cells of the nasal mucosa2,3. Therefore, the nasal cavity represents a highly susceptible mucosal surface for infection and amplification within the respiratory tree. The nasal cavity also allows for treatment with topical compounds that can be delivered in higher local concentrations with potentially lower systemic exposure that may not be achievable when administered as an oral tablet or IV infusion.
In a separate study, in collaboration with the Trudeau Institute, researchers evaluated the in vitro antiviral activity of varenicline against SARS-CoV-2 and SARS-CoV-2 alpha and beta variants using Calu-3 (human airway epithelial cells) and Caco-2 (colon epithelial cells) cell lines. "Varenicline has demonstrated potent antiviral activity against SARS-CoV-2 and variants, alpha and beta, in cell culture. The promising in vitro and in vivo data suggest a clinical path forward for OC-01, which could prove a potential treatment in preventing severe COVID-19 symptoms and the spread of infection. Further studies investigating the mechanism of action and its effect on other variants of concern, such as the gamma and delta variants are ongoing," said Priya Luthra, PhD, Trudeau Institute Principal Investigator.
Additionally, OC-02 (simpinicline), a highly selective nicotinic acetylcholine receptor agonist was evaluated for in vitro antiviral activity against the SARS-CoV-2 alpha variant using Calu-3 cell lines. Simpinicline demonstrated potent antiviral activity against the SARS-CoV-2 variants in cell culture with an IC50 of 0.04 µM. Further studies investigating the antiviral effect on other variants of concern are ongoing.
Given the results of both the in vivo and in vitro studies, OC-01 (varenicline) nasal spray and OC-02 (simpinicline) nasal spray warrant further investigation as an antiviral agent for pre-exposure prophylaxis, post-exposure prophylaxis, and/or prevention of transmission of SARS-CoV-2. Additional in vivo and in vitro studies are ongoing.
OC-01 (varenicline) nasal spray and OC-02 (simpinicline) nasal spray have not been proven safe or effective to prevent SARS-CoV-2 infection or treat COVID-19 in humans nor has OC-01 (varenicline) or OC-02 (simpinicline) nasal spray been approved for any use by the U.S. Food and Drug Administration (FDA). The Prescription Drug User Fee Act (PDUFA) target action date for OC-01 (varenicline) nasal spray is October 17, 2021, with a planned U.S. launch in the fourth quarter of 2021, if approved by the FDA.
Oyster Point Pharma plans to present additional data at the upcoming Oyster Point Analyst Day, planned for July 15, 2021. Please use the following link to register for the Analyst Day (https://media.rampard.com/20210715/).
About Oyster Point Pharma
Oyster Point Pharma is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class pharmaceutical and biologic therapies to treat ophthalmic diseases.About the Trudeau Institute
The Trudeau Institute, headquartered in Saranac Lake, N.Y., safeguards human health by combatting 21st-century global health crises, such as the rise of drug-resistant tuberculosis, COVID-19 and emerging pandemic viruses. Its roots can be traced to 1884, when Edward Livingston Trudeau launched the first American laboratory solely dedicated to tuberculosis research. Today, Trudeau scientists spearhead innovation by conducting urgent biomedical research on infectious disease and collaborating with national and international R&D partners to accelerate medical impact.About OC-01 (varenicline) Nasal Spray
OC-01 (varenicline) nasal spray is a highly selective cholinergic agonist being developed as a multidose preservative-free nasal spray to treat the signs and symptoms of dry eye disease and neurotrophic keratopathy. Varenicline tartrate is a partial nicotinic acetylcholine receptor agonist of α4β2 and α4α6β2 receptors, a moderate α3β4 and α3α5β4 receptor agonist, and a full α7 receptor agonist. Varenicline has been hypothesized to form a complex with an epitope of the Severe Acute Respiratory Syndrome-related Coronavirus 2 (SARS-CoV-2) spike protein that may block binding to receptors important for cellular entry, resulting in the prevention of viral entry into tissues1. The administration of a nasal spray formulation of varenicline provides a high localized dose directly to the nasal mucosa, a frequent site of virus entry, replication and infection. Varenicline has been shown to inhibit viral entry and disrupt replication of SARS-CoV-2-alpha in an in vivo model and has been shown to have potent antiviral activity to SARS-CoV-2, SARS-CoV-2-alpha, and SARS-CoV-2-beta in in vitro assays. The Prescription Drug User Fee Act (PDUFA) target action date is October 17, 2021, with a planned U.S. launch of OC-01 (varenicline) nasal spray in this indication in the fourth quarter of 2021, if approved by the FDA. OC-01 (varenicline) nasal spray is an investigational new drug and has not been approved for any use in any country. The safety and efficacy of OC-01 (varenicline) nasal spray have not been established.
About OC-02 (simpinicline) Nasal Spray
OC-02 (simpinicline) nasal spray is a highly selective cholinergic agonist. Simipinicline citrate is a strong nicotinic acetylcholine receptor agonist of activity at the α4β2, α3β4, α3α5β4, and α4α6β2 receptors and weak agonist activity at the α7 receptor. OC-02 has been previously studied in two Phase 2b clinical trials for dry eye disease.
About the SARS-CoV-2 Virus
The Severe Acute Respiratory Syndrome-related Coronavirus 2 (SARS-CoV-2) is the virus responsible for coronavirus disease 2019 (COVID-19). This virus is from the Coronaviridae family that are broadly distributed among humans, other mammals, and birds. SARS-CoV-2 is a positive-sense single-stranded RNA virus.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 the Company regarding the future of the Company's business, our future plans and strategies, regulatory approvals, 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 product candidates, regulatory approvals, planned preclinical studies and clinical trials, expected results of preclinical or clinical trials, and their timing and likelihood of success, expected research and development costs, as well as plans and objectives of management for future operations, 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: the timing or likelihood of regulatory filings and approvals for OC-01; the beneficial characteristics, safety, efficacy and therapeutic effects of OC-01; our plans relating to the further development and manufacturing of OC-01, including potential additional indications or disease areas to be evaluated and pursued; the timing of initiation of our future 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 our clinical trials demonstrating safety and efficacy of OC-01, and other positive results; our plans and potential for success relating to commercializing OC-01; 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 preclinical studies and clinical trials; 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.- Alexandris, N., Lagoumintzis, G., Chasapis, C. T., Leonidas, D. D., Papadopoulos, G. E., Tzartos, S. J., ... & Farsalinos, K. (2021). Nicotinic cholinergic system and COVID-19: In silico evaluation of nicotinic acetylcholine receptor agonists as potential therapeutic interventions. Toxicology reports, 8, 73-83.
- Sungnak, W., Huang, N., Bécavin, C., Berg, M., Queen, R., Litvinukova, M., ... & Barnes, J. L. (2020). SARS-CoV-2 entry factors are highly expressed in nasal epithelial cells together with innate immune genes. Nature medicine, 26(5), 681-687.
- Gallo, O., Locatello, L. G., Mazzoni, A., Novelli, L., & Annunziato, F. (2020). The central role of the nasal microenvironment in the transmission, modulation, and clinical progression of SARS-CoV-2 infection. Mucosal immunology, 1-12.
Investor Contact:
Tim McCarthy
LifeSci Advisors, LLC
(212) 915-2564
[email protected]Media Contact:
Sheryl Seapy, Real Chemistry
(213) 262-9390
[email protected] - Administration of OC-01 (varenicline) nasal spray to non-human primates was observed to inhibit viral replication in the nose within 24 hours of infectious SARS-CoV-2 challenge with absence of subgenomic RNA at Day 3 and Day 5 post-challenge
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PRINCETON, N.J., June 29, 2021 (GLOBE NEWSWIRE) -- Oyster Point Pharma, Inc. (NASDAQ:OYST), today announced information regarding a key supply chain insight for OC-01 (varenicline) nasal spray following the announcement that an unrelated manufacturer of varenicline oral tablets has suspended distribution due to impurities discovered in one or more lots of its product. Oyster Point Pharma has not observed any measurable impurities in its OC-01 (varenicline) nasal spray.
Oyster Point Pharma is developing OC-01 (varenicline) nasal spray to treat the signs and symptoms of dry eye disease. Oyster Point Pharma currently sources OC-01 (varenicline) nasal spray active pharmaceutical ingredient (API), varenicline tartrate, from a supplier unrelated to the manufacturer that has suspended distribution due to nitrosamine being above acceptable levels.
Oyster Point Pharma takes seriously the quality of products in development and patient safety. To date, Oyster Point Pharma has tested samples of varenicline tartrate API intermediate, multiple lots of varenicline tartrate drug substance used in OC-01 (varenicline) nasal spray finished product, and multiple lots of OC-01 (varenicline) nasal spray finished product with no evidence of nitrosamine levels being above the lower limit of detection from the assay used for measuring presence.
The Prescription Drug User Fee Act (PDUFA) target action date for OC-01 (varenicline) nasal spray is October 17, 2021, with a planned U.S. launch in the fourth quarter of 2021, if approved by the U.S. Food and Drug Administration (FDA).
OC-01 (varenicline) nasal spray is an investigational new drug and has not been approved for any use in any country. The safety and efficacy of OC-01 (varenicline) nasal spray have not been established.
About Oyster Point Pharma
Oyster Point Pharma is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class pharmaceutical and biologic therapies to treat ophthalmic diseases.About OC-01 (varenicline) Nasal Spray
OC-01 (varenicline) nasal spray is a highly selective cholinergic agonist being developed as a multidose preservative-free nasal spray to treat the signs and symptoms of dry eye disease and neurotrophic keratopathy. 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. Administered as a preservative-free, aqueous nasal spray, in pre-clinical and clinical studies, OC-01 (varenicline) nasal spray was shown to have a novel mechanism of action with activation of the trigeminal parasympathetic pathway in the nasal cavity to activate natural tear film production. The 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 mucins. This complex tear film is responsible for forming the primary refracting surface of the eye, as well as protecting and moisturizing the cornea. In December 2020, Oyster Point submitted to the U.S. Food and Drug Administration (FDA) a New Drug Application (NDA) for OC-01 (varenicline) nasal spray for the treatment of signs and symptoms of dry eye disease. The Prescription Drug User Fee Act (PDUFA) target action date is October 17, 2021, with a planned U.S. launch of OC-01 (varenicline) nasal spray in this indication in the fourth quarter of 2021, if approved by the FDA. OC-01 (varenicline) nasal spray is an investigational new drug and has not been approved for any use in any country. The safety and efficacy of OC-01 (varenicline) nasal spray have not been established.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 the "Company regarding the future of the Company's business, our future plans and strategies, regulatory approvals, 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 product candidates, regulatory approvals, planned preclinical studies and clinical trials, expected results of preclinical or clinical trials, and their timing and likelihood of success, expected research and development costs, as well as plans and objectives of management for future operations, 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: the timing or likelihood of regulatory filings and approvals for OC-01; the beneficial characteristics, safety, efficacy and therapeutic effects of OC-01; our plans relating to the further development and manufacturing of OC-01, including potential additional indications or disease areas to be evaluated and pursued; the timing of initiation of our future 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 our clinical trials demonstrating safety and efficacy of OC-01, and other positive results; our plans and potential for success relating to commercializing OC-01; 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 preclinical studies and clinical trials; 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
[email protected]Media Contact:
Sheryl Seapy, Real Chemistry
(213) 262-9390
[email protected]