News Release

Unique and memorable campaign intended to educate consumers about Demodex blepharitis and XDEMVY, the first and only FDA approved solution for the disease

Demodex blepharitis impacts approximately 25 million eye care patients in the U.S. – or 1 out of every 12 adults

Campaign will kick off with a Facebook LIVE event on March 7 at 5pm PT

A Media Snippet accompanying this announcement is available by clicking on this link.

IRVINE, Calif., March 05, 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, announces the launch of “Mite Party,” a dynamic, multi-channel consumer marketing campaign for XDEMVY^® (lotilaner ophthalmic solution) 0.25%, the first and only FDA approved treatment for Demodex blepharitis. “Mite Party” is designed to elevate consumer awareness of Demodex blepharitis through relatable messaging and compelling visuals to encourage patients who may have Demodex blepharitis to seek out an eye care provider for screening.

“We are committed to increasing Demodex blepharitis education and awareness so that patients more effectively understand their disease and are motivated to seek treatment,” said Aziz Mottiwala, Chief Commercial Officer of Tarsus. “The memorable visuals and differentiated messaging in the ‘Mite Party’ campaign are designed to resonate with patients in a meaningful and action-oriented way. We look forward to advancing this novel campaign with the goal of helping as many patients with Demodex blepharitis as possible.”

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), irritation, misdirected eyelashes, and inflammation. The campaign is intended to help patients identify this infestation, or “mite party” on the eyelids and encourage them to see an eye doctor.

“Mite Party” will officially launch on the XDEMVY Facebook page (@xdemvyrx) with a live event designed to “break up the mite parties” on Demodex blepharitis patients’ eyelids. The Facebook event, scheduled for March 7, 2024 at 5pm PT, will feature Mitchell Shultz, MD, FAAO, and Amir Moarefi, MD as well as patients with Demodex blepharitis.

“I’ve seen Demodex in my practice for years, and often, patients come to me without a clear understanding of the disease or how it’s treated,” said Caroline Watson, MD, ophthalmologist at Alabama Vision Center. “The ‘Mite Party’ campaign not only provides education about the disease but also encourages important conversation with providers, and I’m eager to see the potential impact it has on the future diagnosis and treatment of Demodex blepharitis patients.”

The “Mite Party” campaign components are featured on www.xdemvy.com and include a “Find a Doctor” tool, an interactive quiz, real before and after results of patients treated with XDEMVY¹, and other educational information and resources.

“Demodex blepharitis is incredibly common, and I’m delighted that there is a campaign that makes this disease relevant and relatable to patients,” said Mark Schaeffer, OD, optometrist, Birmingham, Ala. “Now that we finally have an FDA-approved treatment for Demodex blepharitis with XDEMVY, we hope more patients will be able to associate how they’re feeling with the disease and proactively visit their eye care providers.”

To learn more about XDEMVY and for Full Prescribing Information, visit xdemvy.com and follow XDEMVY on Facebook and Instagram.

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 treatment of Meibomian Gland Disease, TP-04 for the potential treatment of Rosacea, and TP-05, an oral tablet for the 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 the availability of XDEMVY for prescription; 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 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, 2023 filed on February 27, 2024, 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
akemp@tarsusrx.com

Investor Contact:
David Nakasone
Head of Investor Relations
(949) 620-3223
DNakasone@tarsusrx.com

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_{¹ Individual patient results may vary and are not guaranteed.}