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, today
announced the launch of a new direct-to-consumer TV campaign for
XDEMVY® (lotilaner ophthalmic solution) 0.25%, the first and only
FDA approved treatment for Demodex blepharitis (DB).
Demodex blepharitis occurs when Demodex mites –
the most common ectoparasites found on humans – overpopulate on the
eyelids. This infestation results in eyelid redness, crusties
(collarettes), itching, irritation, misdirected eyelashes and
inflammation. People with Demodex blepharitis often have difficulty
applying makeup or driving at night, and many with the disease
report being conscious of their eyes all day.
The first-of-its-kind campaign, called “Your Mitey Problem,”
provides viewers with an inside look at a Demodex mite ‘party’
taking place on a patient’s eyelids. The uninvited eyelid squatters
are feasting on oily sebum, clawing onto eyelashes and leaving
behind a trail of waste, eyelid redness and inflammation. The chief
of irritation is actress Betsy Sodaro – from CBS’s sitcom ‘Ghosts’
– who, in costume, encourages the other mites to wreak havoc on the
eyelids.
Category-creating XDEMVY represents a significant step forward
in eye care, and this campaign leverages dynamic visuals to
describe the damaging impact potential of Demodex blepharitis on
the eyelids. The goal of the campaign is to support patients in
understanding their disease and drive them to consult with an eye
care provider to see if XDEMVY is right for them.
“For years, millions of patients with Demodex blepharitis have
struggled with limited, suboptimal treatment options and the
frustration of not being able to address the root cause of their
disease,” said Aziz Mottiwala, Chief Commercial Officer of Tarsus.
“This engaging campaign educates patients on both the cause of
disease and the only FDA-approved solution, and it does so with
compelling visuals, action-oriented messaging and just the right
amount of humor and levity. We are excited to reach patients
directly with a fun, inspirational message that encourages them to
prioritize their eyelid health and see an eye care provider.”
“Disease education has always been a critical part of our XDEMVY
commercial strategy, and each of our campaigns has driven action
and delivered significant, lasting impact among providers and
patients,” said Bobak Azamian, M.D., Ph.D., CEO and Chairman of
Tarsus. “With this new highly innovative and exciting campaign, we
are bringing relatable, memorable and motivating messaging directly
to patients. It is yet another example of our category-creating
approach and we look forward to reaching an even greater number of
patients in need.”
The multi-channel campaign is currently live on connected TV
devices and streaming channels and will also include digital and
social media components. The full TV spot can be viewed by visiting
www.xdemvy.com.
For more information on XDEMVY for the treatment of Demodex
blepharitis visit www.xdemvy.com.
About Demodex Blepharitis
Blepharitis 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 mite infestation, and that at least 45 million
people annually visit an eye care
clinic. Demodex blepharitis can have a significant
clinical burden and negative impact on patients’ daily lives.
About XDEMVY®
XDEMVY (lotilaner ophthalmic solution) 0.25%, formerly known as
TP-03, is a novel prescription eye drop for the treatment
of Demodex blepharitis and is designed to target and
eradicate the root cause of the disease – Demodex mite
infestation. The active ingredient in XDEMVY is lotilaner, a
well-characterized agent that 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 follicles where the mites reside. XDEMVY was
evaluated in two pivotal trials collectively involving more than
800 patients. Both trials met the primary endpoint and all
secondary endpoints, with statistical significance and no serious
treatment-related adverse events. Most patients found XDEMVY to be
neutral to very comfortable. The most common ocular adverse
reactions observed in the studies were site stinging and burning
which was reported in 10% of patients. Other ocular adverse
reactions reported by less than 2% of patients were
chalazion/hordeolum (stye) and punctate keratitis.
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 three investigational medicines in
clinical trials. In addition to XDEMVY (lotilaner ophthalmic
solution) 0.25%, which is FDA approved in the United States for the
treatment of Demodex blepharitis, Tarsus is also
investigating TP-03 for the potential treatment of Meibomian Gland
Disease, TP-04 for the potential treatment of Rosacea, and TP-05,
an oral tablet for the potential prevention of Lyme disease, all of
which are in Phase 2.
XDEMVY Indication and Important Safety
Information
Indications and Usage
XDEMVY (lotilaner ophthalmic solution) 0.25% is indicated for
the treatment of Demodex blepharitis.
Important Safety Information
Most common side effects: The most common
side effect in clinical trials was stinging and burning in 10% of
patients. Other side effects in less than 2% of patients were
chalazion/hordeolum and punctate keratitis.
Handling the Container: Avoid allowing the
tip of the dispensing container to contact the eye, surrounding
structures, fingers, or any other surface in order to minimize
contamination of the solution. Serious damage to the eye and
subsequent loss of vision may result from using contaminated
solutions.
When to Seek Physician Advice: Immediately seek
a physician’s advice concerning the continued use of XDEMVY if you
develop an intercurrent ocular condition (e.g., trauma or
infection), have ocular surgery, or develop any ocular reactions,
particularly conjunctivitis and eyelid reactions.
Use with Contact Lenses: XDEMVY contains
potassium sorbate, which may discolor soft contact lenses. Contact
lenses should be removed prior to instillation of XDEMVY and may be
reinserted 15 minutes following its administration.
To report SUSPECTED ADVERSE REACTIONS, contact Tarsus
Pharmaceuticals at 1-888-421-4002 or FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch.
For additional information please see Full Prescribing
Information available at: www.xdemvy.com.
Forward-Looking Statements
Statements 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 potential interest in, and patient access to XDEMVY;
Tarsus’ commercialization plans for and the anticipated benefits of
XDEMVY including its consumer marketing campaign and potential
impact on patient and eye care provider education, screening,
diagnosis, and/or treatment patterns
for Demodex blepharitis; 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, 2023 filed on February 27, 2024 and the most recent Form 10-Q
quarterly filing filed 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
Tarsus Pharmaceuticals (NASDAQ:TARS)
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