Tarsus Launches “Your Mitey Problem,” the First Direct-to-Consumer TV Campaign for XDEMVY® (lotilaner ophthalmic solution) 0.25%

Campaign showcases root cause of Demodex blepharitis through creative representation of mischief-causing mites on patients’ eyelids

Demodex blepharitis is a significant eyelid disease that impacts approximately 25 million people in the U.S. – or 1 out of every 12 adults

Media accompanying this announcement is available by clicking on 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 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 Kemp
Sr. Director, Corporate Communications
(949) 922-0801
[email protected]

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