Tarsus to Present Several Scientific Abstracts Highlighting the Global Prevalence of Demodex Blepharitis and the Clinical Impact of XDEMVY at the American Society of Cataract and Refractive Surgery (ASCRS) 2025 Annual Meeting

Rhea-AI Summary

Tarsus Pharmaceuticals (NASDAQ: TARS) is set to present four significant data sets at the American Society of Cataract and Refractive Surgery (ASCRS) 2025 Annual Meeting in Los Angeles from April 25-28, 2025. The presentations will focus on the global prevalence of Demodex blepharitis and the clinical impact of their treatment, XDEMVY® (lotilaner ophthalmic solution) 0.25%.

The four presentations include:

• The Orion Registry interim results on disease burden and treatment efficacy
• The Janus Study comparing symptoms and clinical outcomes
• Studies on XDEMVY's effectiveness in patients with Meibomian Gland Dysfunction
• The Elara Study on Demodex blepharitis prevalence in Japan

According to Dr. Elizabeth Yeu, Chief Medical Officer of Tarsus, these presentations will reinforce the global burden of Demodex blepharitis and demonstrate XDEMVY's potential to improve patient outcomes across multiple subtypes.

IRVINE, Calif., April 22, 2025 (GLOBE NEWSWIRE) -- Tarsus Pharmaceuticals, Inc. (NASDAQ: TARS) will present four distinct data sets highlighting the global prevalence and real-world patient burden of Demodex blepharitis, as well as the impact of XDEMVY^® (lotilaner ophthalmic solution) 0.25% in addressing objective measures of disease at the American Society of Cataract and Refractive Surgery (ASCRS) 2025 Annual Meeting, taking place April 25-28, 2025, in Los Angeles, Calif.

“From new prevalence data in Japan to real-world results in the US, the findings accepted for oral presentation at ASCRS reinforce the global burden of Demodex blepharitis and the potential of XDEMVY to deliver significant improvements in patient outcomes across multiple subtypes, including those with concomitant meibomian gland disease,” said Elizabeth Yeu, M.D., Chief Medical Officer of Tarsus. “We look forward to continuing to generate new evidence to advance the clinical understanding of XDEMVY and its potential impact on this highly prevalent eyelid disease and on the lives of patients.”

Accepted abstracts include:

Longitudinal Evaluation of Disease Burden and Treatment Efficacy in Patients with Demodex blepharitis: Orion Registry Interim Results
Date: Sunday, April 27, 2025, 10:42 – 10:47 a.m. PT
Location: Los Angeles Convention Center (LACC) – Level 2, 512
Presenter: Kendall E. Donaldson, M.D., M.S., ABO
A real-world, multi-center study characterizing the burden of Demodex blepharitis, the current disease management landscape and key changes in patient outcomes after initiation of treatment with XDEMVY.

Assessment of the Demodex Blepharitis Specific Symptoms: The Janus Study
Date: Monday, April 28, 2025, 8:00 – 8:05 a.m. PT
Location: LACC – Level 2, 506
Presenter: Nicole R. Fram, M.D., ABO
A prospective, observational study that compared symptoms and clinical outcomes in patients with Demodex blepharitis to patients without Demodex blepharitis.

Lotilaner Ophthalmic Solution, 0.25% for the Treatment of Demodex blepharitis Patients with Meibomian Gland Dysfunction
Date: Monday, April 28, 2025, 8:33 – 8:38 a.m. PT
Location: LACC – Level 2, 506
Presenter: Mitchell C. Schultz, M.D., ABO
Two pooled studies that evaluated the safety and efficacy of XDEMVY in patients with Demodex blepharitis and Meibomian Gland Disease.

Prevalence of Demodex blepharitis in Japan: The Elara Study
Date: Monday, April 28, 2025, 10:30 – 10:35 a.m. PT
Location: LACC – Level 2, 504
Presenter: Shizuka Koh, M.D., Ph.D.
An observational, multicenter study highlighting the prevalence and symptomatology of Demodex blepharitis in Japan.

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 designed to treat Demodex blepharitis by targeting and eradicating the root cause of the disease – Demodex mite infestation. 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.

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.

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 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-04 for the potential treatment of Ocular Rosacea and TP-05 as an oral tablet for the potential prevention of Lyme disease.

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 timing, content, location, and presenters of scientific abstracts at an upcoming medical conference, our ability to continue to educate the market and generate data about Demodex blepharitis, the potential market size of Demodex blepharitis globally, 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. 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, 2024, filed on February 25, 2025, with the SEC, 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

FAQ

What are the key findings being presented about XDEMVY at ASCRS 2025?

Tarsus will present four studies at ASCRS 2025, including real-world treatment efficacy data, disease burden assessment, effectiveness in patients with Meibomian Gland Dysfunction, and prevalence data from Japan.

How does XDEMVY treat Demodex blepharitis with Meibomian Gland Dysfunction?

The presentation will share results from two pooled studies evaluating XDEMVY's safety and efficacy specifically in patients with both Demodex blepharitis and Meibomian Gland Disease.

What is the significance of the Elara Study for TARS stock?

The Elara Study expands TARS's market research into Japan, providing important data about Demodex blepharitis prevalence in the Asian market, potentially indicating future market opportunities.

What real-world evidence will be presented about XDEMVY's effectiveness?

The Orion Registry will present interim results from a multi-center study showing real-world disease management outcomes and patient improvements after XDEMVY treatment.

When and where will Tarsus present its XDEMVY research at ASCRS 2025?

The presentations will take place from April 25-28, 2025, at various locations within the Los Angeles Convention Center, with specific times scheduled for each study presentation.