Tarsus Presents New Findings from Two Studies Demonstrating the Impact of Demodex Blepharitis at the ARVO 2022 Annual Meeting
May 05 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 from its Atlas Continuation study on the negative
impact Demodex blepharitis has on daily life and visual function
among certain patient groups, as well as preliminary findings from
the Pandora study on coexisting bacterial burden for patients with
Demodex blepharitis. Both studies were presented at the Association
for Research in Vision and Ophthalmology (ARVO) 2022 Annual
Meeting.
Accepted abstracts include:
- The Impact of Demodex
Blepharitis on Patients and Healthcare System: Results from
the Atlas Continuation Study; Blake Simmons, O.D., et
al.
- Demodex Blepharitis and Coexisting
Bacterial Burden in Eye Care Patients: The Pandora Study;
Kiersten Snyder, M.D., et al.
“This research reinforces the significant burden and clinical
impact of Demodex blepharitis, particularly among the most commonly
seen patients in eye care practices,” said Bobak Azamian, M.D.,
Ph.D., President and Chief Executive Officer of Tarsus. “We also
recently announced strong, positive topline results from our second
pivotal trial, Saturn-2, studying our lead investigational
therapeutic, TP-03, for the treatment of Demodex blepharitis. With
this positive data, we plan to submit a New Drug Application (NDA)
to the U.S. Food and Drug Administration (FDA) later this year,
which is exciting for eye care professionals and the millions of
patients suffering from this disease without an effective treatment
option. We are committed to advancing our path forward to bring a
potential definitive standard of care to these patients in
need.”
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
eyelash follicle where the mites reside. TP-03 was evaluated in two
pivotal trials collectively involving 833 patients. Both trials met
the primary and all secondary endpoints, with statistical
significance and no serious treatment-related adverse events. Both
trials also demonstrated that TP-03 was generally safe and
well-tolerated. 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.
Tarsus 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. Tarsus is
studying two investigational medicines in clinical trials. Its lead
product candidate, TP-03, is a novel therapeutic which has
demonstrated positive results in two pivotal trials 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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