Tarsus Launches “Your Mitey Problem,” the First Direct-to-Consumer TV Campaign for XDEMVY® (Lotilaner Eye Solution) 0.25%

The campaign highlights the cause of Demodex blepharitis by creatively depicting mites on patients’ eyelids causing mischief

Demodex blepharitis is a serious eyelid disease that affects approximately 25 million people in the United States – or one in 12 adults

Media accompanying this announcement is available by clicking this link

IRVINE, Calif., Oct. 17, 2024 (GLOBE NEWSWIRE) — Tarsus Pharmaceuticals, Inc. (NASDAQ: TARS), whose mission is to focus on unmet needs and apply proven science and new technologies to revolutionize the way patients are treated 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 in humans – overpopulate the eyelids. This infestation results in eyelid redness, crusting (collaring), itching, irritation, misguided eyelashes, and inflammation. people with Demodex Blepharitis patients often have difficulty applying makeup or driving at night, and many sufferers report paying attention to their eyes throughout the day.

The unique campaign titled “Your Mitey Problem” offers viewers a glimpse into a Demodex Mite “party” taking place on a patient’s eyelids. The uninvited eyelid occupiers eat greasy sebum, scratch their eyelashes and leave a trail of waste, eyelid redness and inflammation. The main culprit of the irritation is actress Betsy Sodaro – from the CBS sitcom “Ghosts” – who dresses in costume and encourages the other mites to wreak havoc on the eyelids.

The creation of the XDEMVY category represents a significant advancement in eye care, and this campaign uses dynamic images to describe the potential for harmful effects Demodex Blepharitis of the eyelids. The campaign aims to help patients understand their disease and encourage them to contact an eye doctor to find out if XDEMVY is right for them.

“Millions of patients have been suffering for years Demodex Blepharitis sufferers struggle 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 dedicated campaign educates patients about both causes of the disease And the only FDA-approved solution, with compelling visuals, action-oriented messaging, and just the right amount of humor and lightness. We’re excited to reach patients directly with a fun, inspirational message that encourages them to prioritize their eyelid health and see an eye doctor.”

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“Illness education has always been a critical part of our XDEMVY business strategy, and each of our campaigns has driven action and achieved significant, lasting impact among providers and patients,” said Bobak Azamian, M.D., Ph.D., CEO and Chairman of Tarsus. “With this new, extremely innovative and exciting campaign, we are bringing relatable, memorable and motivating messages to patients. It is another example of our category creation approach and we look forward to reaching an even greater number of patients in need.”

The multi-channel campaign is currently running live on connected TV devices and streaming channels and will also include digital and social media components. The full TV spot can be viewed at www.xdemvy.com.

Learn more about XDEMVY to treat Demodex Blepharitis visit www.xdemvy.com.

Um Demodex Blepharitis

Blepharitis is a common eyelid margin disease characterized by inflammation of the eyelid margin, redness, and eye irritation. Demodex Blepharitis is caused by an infestation Demodex Mites are the most common ectoparasite in humans and account for over two-thirds of all blepharitis cases. Demodex Blepharitis may affect up to 25 million Americans, based on an extrapolation from the Titan study that says 58% of patients presenting to U.S. eye clinics have collars, a pathognomonic sign of Demodex mite infestation, and that at least 45 million people visit an eye clinic every year. Demodex Blepharitis can impose a significant clinical burden and negatively impact 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 aims to target and eliminate the root cause of the disease – Demodex Mite infestation. The active ingredient in XDEMVY is lotilaner, a well-characterized eradication agent Demodex Mites through selective inhibition of GABA-Cl channels. It is a highly lipophilic molecule that can promote its absorption in the oily sebum of the eyelash follicles where the mites reside. XDEMVY was studied in two pivotal studies involving a total of more than 800 patients. Both studies met the primary endpoint and all secondary endpoints with statistical significance and no serious treatment-emergent adverse events. Most patients found XDEMVY neutral to very pleasant. The most common ocular adverse reactions observed in the studies were stinging and burning at the site, reported in 10% of patients. Other ocular adverse reactions reported in less than 2% of patients included chalazion/hordeolum (stye) and punctate keratitis.

About Tarsus Pharmaceuticals, Inc.

Tarsus Pharmaceuticals, Inc. leverages proven science and new technologies to revolutionize the way patients are treated, starting with eye care. Tarsus is advancing its pipeline to treat multiple diseases with high unmet needs across a range of therapeutic categories, including eye care, dermatology and infectious disease prevention. Tarsus is evaluating three investigational drugs in clinical trials. In addition to XDEMVY (lotilaner ophthalmic solution) 0.25%, which is FDA-approved for treatment in the United States Demodex Blepharitis, Tarsus is also studying 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 Notice and Important Safety Information

Indications and use

XDEMVY (lotilaner ophthalmic solution) 0.25% is indicated for the treatment of Demodex Blepharitis.

Important safety information

The most common side effects: The most common adverse reaction in clinical trials was stinging and burning in 10% of patients. Other side effects included chalazion/hordeolum and punctate keratitis in less than 2% of patients.

Handling the container: Avoid contact of the tip of the dosing container with the eye, surrounding structures, fingers or other surfaces to minimize contamination of the solution. Using contaminated solutions can cause serious eye damage and subsequent vision loss.

When to seek medical advice: Seek immediate medical advice regarding continued use of XDEMVY if you experience any intercurrent eye disease (e.g., trauma or infection), undergo eye surgery, or develop eye reactions, especially conjunctivitis and eyelid reactions.

Use with contact lenses: XDEMVY contains potassium sorbate, which can discolor soft contact lenses. Contact lenses should be removed prior to instillation of XDEMVY and may be reinserted 15 minutes after administration.

To report suspected side effects, contact Tarsus Pharmaceuticals at 1-888-421-4002 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

For more information, see full prescribing information at: www.xdemvy.com.

Forward-Looking Statements

Statements in this press release regarding future expectations, plans and prospects and any other statements on matters that are not historical facts may be “forward-looking statements.” These statements include statements regarding potential interest in and patient access to XDEMVY; Tarsus’ commercialization plans for XDEMVY and expected benefits Demodex blepharitis; and the quotes from Tarsus management. The words “believe,” “consider,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “could,” “plan,” “potential” are permitted without limitation. “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 in such forward-looking statements as a result of various important factors. In addition, there are other risks and uncertainties that could cause actual results to differ from those set forth in the forward-looking statement. These 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 quarterly filing on Form 10-Q filed with the SEC, which Tarsus incorporates by reference into this press release, copies of which Tarsus has posted on its website are available from Tarsus free of charge. However, new risk factors and uncertainties may arise 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. All 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 of this press release. Tarsus expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Contacts:

Media contact:
Adrienne Kemp
Senior Director, Corporate Communications
(949) 922-0801
[email protected]

Contact for investors:
David Nakasone
Head of Investor Relations
(949) 620-3223
[email protected]