Oyster Point Pharma, Inc. (Nasdaq: OYST), a commercial-stage
biopharmaceutical company focused on the discovery, development,
and commercialization of first-in-class pharmaceutical therapies to
treat ophthalmic diseases, today announced the presentation of
analyses at the Women in Ophthalmology (WIO) Summer Symposium,
which is taking place in Monterey, California from August 25-28,
2022.
“We look forward to this year’s WIO Summer
Symposium, a curated meeting for women offering content in all
subjects of importance to women ophthalmologists,” said Marian
Macsai, MD chief medical officer, Oyster Point Pharma.
“Collectively, the TYRVAYA® data we’re presenting show consistency
in treatment effect with a favorable tolerability and safety
profile for people living with dry eye disease, a condition that is
more common in women.”
Details for the Oyster Point New Data Presentations are
below:
Title: Fellow Eye Outcomes with Pharmacologic
Neuro-Activator Nasal Spray in Dry Eye Disease: ONSET-1 &
ONSET-2 StudiesAuthors: Laura Periman, MD and
Sathi Maiti, OD Date/Time: Friday, August 26,
11:15 AM - 12:15 PM PDT
Title: OC-01 (varenicline solution) Nasal Spray
for the Treatment of Dry Eye Disease Signs and Symptoms in Subjects
with Autoimmune Disease: Integrated Data from ONSET-1 and
ONSET-2Author: Julie Schallhorn, MD, MS
Date/Time: Friday, August 26, 11:15 AM - 12:15 PM
PDT
Title: Evaluation of OC-01 (varenicline
solution) Nasal Spray 0.03mg Effectiveness Based on Menopausal
Status: Post-hoc Analysis of ONSET-1 and ONSET-2 Clinical
TrialsAuthor: Dagny Zhu, MD
Date/Time: Saturday, August 27, 9:10 - 9:55 AM
PDT
About Oyster Point PharmaOyster
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 Twitter and LinkedIn.
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® (varenicline solution) Nasal Spray.Please see full
Prescribing Information at
www.tyrvaya-pro.com/prescribinginformation.
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.1,2 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 mucins.3 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.
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,
commercial opportunities, interactions with regulators, regulatory
approvals, preclinical and clinical results, future financial
condition, the 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 conditions. The words "if
approved," “may,” “will,” “should,” “would,” “expect,” “plan,”
“pipeline,” “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. The reader is cautioned not to rely on these
forward-looking statements. All forward-looking statements
contained in this press release are based on current expectations
and assumptions of the Company, and are subject to a number of
risks, uncertainties and assumptions, including, among other
things: the Company’s plans and potential for success relating to
commercializing TYRVAYA, and the availability and sufficiency of
third-party payor coverage and reimbursement in connection with
TYRVAYA; the Company's estimates associated with the Company's plan
to streamline operating expenses, including the associated
reduction in force, and any resulting savings benefits the Company
expects to achieve; the beneficial characteristics, safety,
efficacy and therapeutic effects of TYRVAYA and the Company’s
preclinical and clinical product candidates; the Company’s plans
relating to the further 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 initiation 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 product or product candidates; the timing or
likelihood of regulatory filings and approvals of TYRVAYA and our
clinical and preclinical candidates, including in potential
additional indications for TYRVAYA and potential filings in
additional jurisdictions; the prevalence of dry eye disease and
Neurotrophic Keratopathy (NK) and the size of the market
opportunities for the Company’s product candidates; the expected
potential benefits of strategic collaborations with third parties
and the Company’s ability to attract collaborators 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 throughout the world,
including extensions of existing patent terms where available; the
Company’s continued reliance on third parties to conduct additional
preclinical studies and clinical trials of its product candidates,
and for the manufacture of its product and product candidates;
economic factors, such as interest rate and currency exchange rate
fluctuations; manufacturing difficulties or delays, internally or
within the supply chain; product efficacy or safety concerns
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 COVID-19 global
pandemic, such as the scope and duration of the outbreak,
government actions and restrictive measures implemented in
response, material delays and cancellations of medical procedures,
supply chain disruptions and other impacts to the business, or on
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 needed to develop and commercialize its
product and product candidates, and to grow the Company; the
accuracy of the Company’s estimates regarding expenses, future
revenue, capital requirements and needs for additional financing;
the Company’s financial performance; market conditions; the
sufficiency 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 qualify as an emerging growth company under the JOBS Act. A
further list and descriptions of these risks, uncertainties and
other factors can be found in the Company’s Annual Report on Form
10-K for the fiscal year ended December 31, 2021, including in the
sections captioned “Special Note Regarding Forward-Looking
Statements” and “Item 1A. Risk Factors,” and in the Company’s
subsequent Quarterly Reports on Form 10-Q and other filings that it
makes with the Securities and Exchange Commission from time to
time. Copies of these filings are available online at
www.oysterpointrx.com. Any forward-looking statement made in this
press release speaks only as of the date of this release. The
Company does not undertake to update any forward-looking statement
as a result of new information or future events or developments,
except as required by law. No representations or warranties
(expressed or implied) are made about the accuracy of any such
forward-looking statements.
References:1. Wirta, D.,
Vollmer, P., Paauw, J., Chiu, K. H., 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 ONSET-2 Phase 3, Randomized Trial. Ophthalmology.
https://doi.org/10.1016/j.ophtha.2021.11.0042. 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/
Investor ContactArty Ahmed
(646) 436-4702 aahmed@oysterpointrx.com
Media ContactKaren
Castillo-Paff(347) 920-0248kpaff@oysterpointrx.com
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