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,
announced that XDEMVY™ (lotilaner ophthalmic solution)
0.25% is now available at pharmacies nationwide for
prescription. The U.S. Food and Drug Administration (FDA) approved
XDEMVY on July 24, 2023, for the treatment of Demodex blepharitis.
“We are delighted that within weeks of FDA approval, XDEMVY is
now available to millions of patients with Demodex blepharitis,”
said Bobak Azamian, MD, PhD, Chief Executive Officer and Chairman
of Tarsus. “The efforts of our team have created incredible
interest in XDEMVY, the first and only approved solution for this
highly prevalent disease. I’m so appreciative of our team and our
partners who’ve worked diligently to bring this product to eye care
providers and patients quickly and seamlessly following regulatory
approval. We are proud to introduce XDEMVY to the eye care
community and look forward to its potential to significantly change
the way this disease is treated.”
XDEMVY is the only FDA approved treatment to directly target
Demodex mites, the root cause of Demodex blepharitis. Demodex
blepharitis is characterized by redness, inflammation, missing or
misdirected eyelashes, itching along the eyelid base, and the
presence of collarettes. XDEMVY is a prescription eye drop that is
administered with one drop in each eye twice daily (approximately
12 hours apart) for 6 weeks.
Tarsus is committed to ensuring that patients have affordable
and broad access to XDEMVY and developed Tarsus Connect, a suite of
assistance programs that provide financial support for eligible
patients. More information about Tarsus Connect can be found on
xdemvy.com or by calling: 1-866-846-3092.
To learn more about XDEMVY, including the Full Prescribing
Information, please visit xdemvy.com and follow XDEMVY on Facebook
and Instagram.
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 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. The
Titan study also showed that current management tools, such as tea
tree oil and lid wipes, are ineffective at targeting the root cause
of Demodex blepharitis.
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 treatment
of Meibomian Gland Disease, which is currently being studied in a
Phase 2a clinical trial. In addition, Tarsus is developing TP-04
for the potential treatment of Rosacea and TP-05, an oral tablet
for the prevention of Lyme disease. TP-04 and TP-05 are both
currently being studied in Phase 2a clinical trials to evaluate
safety, tolerability, and proof-of activity.
XDEMVY Indication and Important Safety
Information
Indications and UsageXDEMVY (lotilaner
ophthalmic solution) 0.25% is indicated for the treatment of
Demodex blepharitis.
Important Safety InformationMost 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.
For additional information please see Full Prescribing
Information available at: www.xdemvy.com.
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 availability of
XDEMVY for prescription; potential market size for, interest in,
and patient access to and affordability of XDEMVY; Tarsus’
commercialization plans for and the anticipated benefits of XDEMVY;
and the quotations of Tarsus’ management and consultants/eye care
providers. 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, 2022 filed on March 17, 2023 and the
most recent Form 10-Q quarterly filing filed with the SEC on August
10, 2023, each of 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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