Tarsus Presents Results of Two Studies Highlighting Demodex Blepharitis Patient Impact and Burden at the ASCRS 2022 Annual Meeting
April 26 2022 - 8:30AM
Tarsus Pharmaceuticals, Inc. (NASDAQ: TARS), whose mission is to
focus on unmet needs and apply proven science and new technology to
revolutionize treatment for patients, starting with eye care,
presented data yesterday from its Atlas Continuation study on the
negative impacts to daily life and visual function, and preliminary
findings from its Pandora study on pathogenic bacterial count, for
patients with Demodex blepharitis at the American Society of
Cataract and Refractive Surgery (ASCRS) 2022 Annual Meeting.
Accepted abstracts include:
- Impact of Demodex
Blepharitis on Patients: Results of the Atlas
Trial (ASCRS Paper ID 81946); Mitchell A. Jackson, M.D.,
et al.
- Demodex Blepharitis and Coexisting
Bacterial Burden in Eye Care Patients: The Pandora Study
(ASCRS Paper ID 81932); Elizabeth Yeu, M.D., et al.
“Data from these studies demonstrate that patients with Demodex
blepharitis continue to experience significant detriment to their
daily lives, with no effective, well-tolerated or FDA-approved
options,” said Bobak Azamian, M.D., Ph.D., President and Chief
Executive Officer of Tarsus. “This research enables us to obtain
additional, compelling insights into this significantly underserved
patient population and reinforces our commitment to the Demodex
blepharitis community. As we prepare to imminently share topline
results from our pivotal Saturn-2 trial for TP-03, we are hopeful
that we’ll be able to bring a safe and effective treatment forward
for FDA review, which may offer a solution to the millions of
patients struggling with Demodex blepharitis.”
About TP-03TP-03 (lotilaner ophthalmic
solution, 0.25%) is a novel, investigational therapeutic designed
to resolve the signs of Demodex blepharitis by targeting and
eradicating the root cause of the disease – Demodex mite
infestation. Lotilaner is a well-characterized anti-parasitic agent
that paralyzes and eradicates Demodex mites by selectively
inhibiting the GABA-Cl channels. It is a highly lipophilic
molecule, which may promote its uptake in the oily sebum of the
hair follicle where the mites reside. TP-03 was evaluated in the
pivotal Saturn-1 (Phase 2b/3) trial involving 421 patients and
successfully met the primary and secondary endpoints with no
serious treatment-related adverse events and was well tolerated.
TP-03 is currently being evaluated in the Saturn-2 pivotal Phase 3
trial. If approved, TP-03 may offer treatment for millions of
patients with Demodex blepharitis.
About Demodex
BlepharitisBlepharitis is a common lid margin
disease that is characterized by eyelid margin inflammation,
redness and ocular irritation. Demodex blepharitis is caused by an
infestation of Demodex mites, the most common ectoparasite found on
humans, and accounts for over two-thirds of all blepharitis cases.
Demodex blepharitis may affect as many as 25 million Americans
based on an extrapolation from the Titan study indicating 58% of
patients presenting to U.S. eye care clinics have collarettes, a
pathognomonic sign of Demodex infestation, and that at least 45
million people annually visit an eye care clinic. Demodex
blepharitis can have a significant clinical burden and negatively
impact patients’ daily lives. The Titan study also showed that
current management tools, such as tea tree oil and lid wipes, are
ineffective at treating Demodex blepharitis. Currently, there are
no FDA-approved treatments for Demodex blepharitis.
About Tarsus Pharmaceuticals, Inc.Tarsus
Pharmaceuticals, Inc. applies proven science and new technology to
revolutionize treatment for patients, starting with eye care. It is
advancing its pipeline to address several diseases with high unmet
need across a range of therapeutic categories, including eye care,
dermatology and infectious disease prevention. The company is
studying two investigational medicines in clinical trials. Its lead
product candidate, TP-03, is a novel therapeutic being studied in a
second Phase 3 pivotal trial for the treatment of Demodex
blepharitis. TP-03 is also being developed for the treatment of
Meibomian Gland Disease. In addition, Tarsus is developing TP-05,
an oral, non-vaccine therapeutic for the prevention of Lyme
disease, which is currently being studied in a Phase 1b clinical
trial.
Forward-Looking StatementsStatements in this
press release about future expectations, plans and prospects, as
well as any other statements regarding matters that are not
historical facts, may constitute “forward-looking statements.”
These statements include statements regarding the potential market
size for TP-03, future events and Tarsus’ plans for and the
anticipated benefits of its product candidates including TP-03, the
timing, objectives and results of the clinical trials including the
potential complete clinical results of the Saturn-2 trial,
anticipated regulatory and development milestones and the
quotations of Tarsus’ management. The words, without limitation,
“believe,” “contemplate,” “continue,” “could,” “estimate,”
“expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,”
“project,” “should,” “target,” “will,” or “would,” 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 or similar identifying
words. Actual results may differ materially from those indicated by
such forward-looking statements as a result of various important
factors. Further, there are other risks and uncertainties that
could cause actual results to differ from those set forth in the
forward-looking statement and they are detailed from time to time
in the reports Tarsus files with the Securities and Exchange
Commission, including Tarsus’ Form 10-K for the year ended December
31, 2021 filed on March 14, 2022 with the SEC, which Tarsus
incorporates by reference into this press release, copies of which
are posted on its website and are available from Tarsus 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. Accordingly, readers are cautioned not to place
undue reliance on these forward-looking statements. Any
forward-looking statements contained in this press release are
based on the current expectations of Tarsus’ management team and
speak only as of the date hereof, and Tarsus specifically disclaims
any obligation to update any forward-looking statement, whether as
a result of new information, future events or otherwise.
Contacts: Media Contact:Adrienne KempSr.
Director, Corporate Communications(949)
922-0801akemp@tarsusrx.com
Investor Contact:David NakasoneHead of Investor Relations(949)
620-3223DNakasone@tarsusrx.com
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