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 that the U.S. Food and Drug Administration (FDA) approved
XDEMVY™ (lotilaner ophthalmic solution) 0.25% for the
treatment of Demodex blepharitis. XDEMVY, formerly known as
TP-03, is the first and only FDA approved treatment to directly
target Demodex mites, the root cause of Demodex blepharitis.
“We are thrilled to announce the FDA approval of
XDEMVY for the treatment of Demodex blepharitis and look forward to
making this product broadly available to the millions of patients
who have not had any FDA approved therapeutics for this disease,”
said Bobak Azamian, MD, PhD, Chief Executive Officer and Chairman
of Tarsus. “This tremendous milestone was achieved through a
successful collaboration of our talented Tarsus team, countless eye
care providers and the hundreds of patients who participated in our
trials. We are grateful and honored for the opportunity to
introduce the first and only approved therapeutic for this disease
to the eye care community.”
The FDA approval is based on results from two
randomized, multicenter, double-masked, vehicle-controlled studies
(Saturn-1 and Saturn-2), designed to evaluate the safety and
efficacy of XDEMVY in 833 patients, 415 of which received XDEMVY.
Patients with Demodex blepharitis were randomized to either XDEMVY
or vehicle at a 1:1 ratio and dosed twice daily in each eye over
the course of 6 weeks.
Efficacy was demonstrated by a significant
improvement in eyelids (reduction of collarettes, the pathognomonic
sign of the disease, to no more than 2 collarettes per upper lid)
in each study by Day 43, with some patients seeing improvement as
early as 2 weeks. Additionally, the endpoints of mite eradication
(mite density of 0 mites per lash) and erythema cure (Grade 0)
showed statistically significant improvement at Day 43 across both
studies. In clinical trials, XDEMVY was generally safe and well
tolerated. The most common ocular adverse reactions observed in the
studies were instillation site stinging and burning which was
reported in 10% of patients. Other ocular adverse reactions
reported in less than 2% of patients were chalazion/hordeolum
(stye) and punctate keratitis.
“After years of seeing Demodex blepharitis in my
practice without an effective way to target the root cause of the
disease, I’m so pleased to have a new treatment to offer my
patients,” said Christopher Starr, MD, Associate Professor of
Ophthalmology, Director of Refractive Surgery, Ophthalmic Education
and the Cornea Fellowship Program at Weill Cornell Medicine, New
York Presbyterian Hospital. “Demodex blepharitis, easily diagnosed
by the presence of eyelash collarettes, can result in ocular damage
in multiple ways, including irritation, eyelash distention or loss
and inflammation, which can be uncomfortable for patients. This new
medicine is a positive step forward for the treatment of this
disease in many patients who have been struggling for years.”
“More than half of the patients in my practice
present with Demodex blepharitis, and to date, we’ve not had any
FDA approved therapies to treat the disease,” said Selina McGee,
OD, FAAO, BeSpoke Vision. “Many patients have experienced redness,
crusting and overall ocular discomfort for years and I am excited
to finally be able to offer an FDA-approved treatment for my
patients.”
Demodex blepharitis impacts approximately 25
million eye care patients in the U.S. – or 1 out of every 12
adults. It is a common yet often misdiagnosed or underdiagnosed
eyelid disease that is caused by an infestation of Demodex mites,
the most common ectoparasite found on human skin. Demodex
blepharitis is characterized by redness, inflammation, missing or
misdirected eyelashes, horizontal itching along the eyelid base and
the presence of collarettes. Collarettes are cylindrical, waxy
debris of mite waste products and eggs found at the base of the
eyelashes.
For more information about XDEMVY and Full
Prescribing Information, please visit www.xdemvy.com.
Webcast Information
Management will host a live webcast on July 25 and
the webcast can be accessed on the events section of the Company’s
Investor Relations website. After the live webcast, the event will
remain archived on the Tarsus website for at least 90 days.
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 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 designed to treat Demodex blepharitis by
targeting and eradicating the root cause of the disease – Demodex
mite infestation. The active ingredient in XDEMVY is lotilaner,
which is a well-characterized agent that eradicates Demodex mites
by selectively inhibiting the mite’s GABA-Cl channels. It is a
highly lipophilic molecule, which may promote its uptake in the
oily sebum of the eye lash 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 the XDEMVY
eye drop to be neutral to very comfortable. The most common ocular
adverse reactions observed in the studies were instillation 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. XDEMVY (lotilaner ophthalmic solution) 0.25% is FDA
approved in the United States for the treatment of Demodex
blepharitis. Tarsus is also developing 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 is
indicated for the treatment of Demodex blepharitis.
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.
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 timing and availability of XDEMVY for prescription;
potential market size for 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 May 9, 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
Photos accompanying this announcement are available
athttps://www.globenewswire.com/NewsRoom/AttachmentNg/e29d3564-45b2-49b3-b5f7-451c12630fe6https://www.globenewswire.com/NewsRoom/AttachmentNg/6b62917c-8c98-4a26-a2e7-ae647cff556c
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