Oyster Point Pharma Inc logo

OYST - Oyster Point Pharma Inc News Story

$21.19 0.2  0.9%

Last Trade - 14/04/21

Sector
Healthcare
Size
Mid Cap
Market Cap £395.8m
Enterprise Value £255.7m
Revenue £n/a
Position in Universe 3426th / 6848

Oyster Point Pharma Announces FDA Acceptance for Filing New Drug Application for OC-01 (varenicline) Nasal Spray for the Treatment of Signs and Symptoms of Dry Eye Disease

Tue 2nd March, 2021 11:00am
For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20210302:nGNX8S4sBB&default-theme=true

* Prescription Drug User Fee Act (PDUFA) target action date is October 17,
2021
* U.S. Food and Drug Administration (FDA) has stated that it does not intend
to hold an advisory committee meeting to discuss this application
* Planned U.S. launch of OC-01 (varenicline) nasal spray in fourth quarter of
2021, if approved by the FDA
PRINCETON, N.J., March 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 ocular surface diseases, today announced that the U.S. Food
and Drug Administration (FDA) has accepted its 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 for
OC-01 (varenicline) nasal spray is October 17, 2021.   At present, FDA has
stated that it does not intend to hold an advisory committee meeting to
discuss this application.

The NDA submission was supported by safety and efficacy results from the Phase
3 ONSET-2, Phase 2b ONSET-1, and Phase 2 MYSTIC clinical trials in over 1,000
subjects with mild, moderate or severe symptoms of dry eye disease. In these
clinical trials, OC-01 (varenicline) nasal spray demonstrated statistically
significant improvements, as compared to control, in Schirmer’s Score (an
objective, reproducible, and quantifiable measure of natural tear film
production), which was the primary endpoint in all trials. Key secondary
endpoints in ONSET-1 and ONSET-2 included change from baseline in symptoms as
assessed by eye dryness score. In both of these pivotal trials, there was
statistically or nominally statistically significant improvement in symptom
scores at Day 28, and in ONSET-2 as early as Day 14, in patients treated with
OC-01 (varenicline) nasal spray as compared to control. All doses studied in
the clinical trial program were well-tolerated with no serious drug related
adverse events.

“The FDA acceptance of our NDA for OC-01 (varenicline) nasal spray
represents a major milestone towards our goal of bringing novel and
potentially transformational therapies to patients with ocular surface
diseases,” said Jeffrey Nau, Ph.D., M.M.S., president and CEO of Oyster
Point Pharma. “We look forward to continued interaction with the FDA during
the review.”

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. 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 stimulate natural tear film production. 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 cornea, as well as protecting and moisturizing the cornea. 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 previously been established.

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.

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 ocular surface diseases. Oyster Point
Pharma’s lead product candidate, OC-01 (varenicline) nasal spray, a highly
selective cholinergic agonist, is being developed as a nasal spray to treat
the signs and symptoms of dry eye disease. In pre-clinical and clinical
studies, OC-01 (varenicline) nasal spray was shown to have a novel mechanism
of action via activation of the trigeminal parasympathetic pathway to
stimulate the glands and cells responsible for natural tear film production,
known as the lacrimal functional unit. For more information, visit
www.oysterpointrx.com and follow @OysterPointRx on Twitter
(https://www.globenewswire.com/Tracker?data=OasS_59VF0Yr_Bhj01eJ_2gRDO7jp8wqUTGlibOQCmKt-N84hlbw78ZbI5E1AeNTneoRyqFkth8IyCqZG9sAdQ==)
and LinkedIn
(https://www.globenewswire.com/Tracker?data=Uv3dddiygV6CV--cs4_75fg8ERqpSwrOXqkT01330IABNPzJld2ijqK_uFcrlQ4BdrOeWsygIt056EqndkO0uoGcnlB0SsM2IbeZeL4fVyo=).

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, its future plans and strategies,
regulatory approvals and clinical results. All statements other than
statements of historical facts contained in this press release, including
express or implied statements regarding business strategy, product candidates,
regulatory approvals, planned preclinical studies and clinical trials,
expected results of clinical trials, and their timing and likelihood of
success, as well as plans and objectives of management for future operations,
are forward-looking statements. The words “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 our
product candidates; 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; our plans relating to the further development and
manufacturing of our product candidates, including the size, number and
additional indications or disease areas to be evaluated and pursued; the
impact of the COVID-19 pandemic on our business, operations, and regulatory
and clinical development timelines, plans and expectations; the size of the
market opportunities and prevalence of dry eye disease and Neurotrophic
Keratopathy (NK) for our product candidates, the likelihood of our clinical
trials demonstrating safety and efficacy of our product candidates, and other
positive results; the timing of initiation of our future clinical trials, and
the reporting of data from our current and future trials; the expected
potential benefits of strategic collaborations with third parties and our
ability to attract collaborators with development, regulatory and
commercialization expertise; existing regulations and regulatory developments
in the United States and other jurisdictions; our plans and ability to obtain
or protect intellectual property rights, including extensions of existing
patent terms where available; our continued reliance on third parties to
conduct additional clinical trials of our product candidates, and for the
manufacture of our product candidates for preclinical studies and clinical
trials, and potentially for commercial supply; 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; our expectations regarding the
period during which we will qualify as an emerging growth company under the
JOBS Act; 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, W2O Group
(949) 903-4750
sseapy@w2ogroup.com


(https://www.globenewswire.com/NewsRoom/AttachmentNg/4fced6c3-e6da-4081-8986-0dd0667a8d7f)



GlobeNewswire, Inc. 2021
© Stockopedia 2021, Refinitiv, Share Data Services.
This site cannot substitute for professional investment advice or independent factual verification. To use it, you must accept our Terms of Use, Privacy and Disclaimer policies.