Tarsus Presents Results of Two Studies Highlighting Demodex Blepharitis Patient Impact and Burden at the ASCRS 2022 Annual Meeting

Rhea-AI Summary

Tarsus Pharmaceuticals (NASDAQ: TARS) presented significant findings at the ASCRS 2022 Annual Meeting, highlighting the substantial impact of Demodex blepharitis on patients' daily lives. The Atlas Continuation study revealed ongoing challenges for patients, while the Pandora study focused on bacterial counts. CEO Bobak Azamian emphasized the urgent need for effective treatment options as the company prepares to share topline results from the pivotal Saturn-2 trial for TP-03, an investigational treatment targeting Demodex mites, which currently has no FDA-approved solutions.

Positive

• Successful completion of the Saturn-1 trial for TP-03 with positive primary and secondary endpoint results.
• TP-03 is well-tolerated with no serious treatment-related adverse events reported.
• Potential FDA approval for TP-03 could address a significant unmet need for millions suffering from Demodex blepharitis.

Negative

• No FDA-approved treatments for Demodex blepharitis currently exist, indicating market challenges.
• Patients continue to experience significant detriment to their daily lives from Demodex blepharitis.

IRVINE, Calif., April 26, 2022 (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, presented data yesterday from its Atlas Continuation study on the negative impacts to daily life and visual function, and preliminary findings from its Pandora study on pathogenic bacterial count, for patients with Demodex blepharitis at the American Society of Cataract and Refractive Surgery (ASCRS) 2022 Annual Meeting.

Accepted abstracts include:

• Impact of Demodex Blepharitis on Patients: Results of the Atlas Trial (ASCRS Paper ID 81946); Mitchell A. Jackson, M.D., et al.
• Demodex Blepharitis and Coexisting Bacterial Burden in Eye Care Patients: The Pandora Study (ASCRS Paper ID 81932); Elizabeth Yeu, M.D., et al.

“Data from these studies demonstrate that patients with Demodex blepharitis continue to experience significant detriment to their daily lives, with no effective, well-tolerated or FDA-approved options,” said Bobak Azamian, M.D., Ph.D., President and Chief Executive Officer of Tarsus. “This research enables us to obtain additional, compelling insights into this significantly underserved patient population and reinforces our commitment to the Demodex blepharitis community. As we prepare to imminently share topline results from our pivotal Saturn-2 trial for TP-03, we are hopeful that we’ll be able to bring a safe and effective treatment forward for FDA review, which may offer a solution to the millions of patients struggling with Demodex blepharitis.”

About TP-03
TP-03 (lotilaner ophthalmic solution, 0.25%) is a novel, investigational therapeutic designed to resolve the signs of Demodex blepharitis by targeting and eradicating the root cause of the disease – Demodex mite infestation. Lotilaner is a well-characterized anti-parasitic agent that paralyzes and 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 hair follicle where the mites reside. TP-03 was evaluated in the pivotal Saturn-1 (Phase 2b/3) trial involving 421 patients and successfully met the primary and secondary endpoints with no serious treatment-related adverse events and was well tolerated. TP-03 is currently being evaluated in the Saturn-2 pivotal Phase 3 trial. If approved, TP-03 may offer treatment for millions of patients with Demodex blepharitis.

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 infestation, and that at least 45 million people annually visit an eye care clinic. Demodex blepharitis can have a significant clinical burden and negatively impact patients’ daily lives. The Titan study also showed that current management tools, such as tea tree oil and lid wipes, are ineffective at treating Demodex blepharitis. Currently, there are no FDA-approved treatments for Demodex blepharitis.

About Tarsus Pharmaceuticals, Inc.
Tarsus Pharmaceuticals, Inc. applies proven science and new technology to revolutionize treatment for patients, starting with eye care. It 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. The company is studying two investigational medicines in clinical trials. Its lead product candidate, TP-03, is a novel therapeutic being studied in a second Phase 3 pivotal trial for the treatment of Demodex blepharitis. TP-03 is also being developed for the treatment of Meibomian Gland Disease. In addition, Tarsus is developing TP-05, an oral, non-vaccine therapeutic for the prevention of Lyme disease, which is currently being studied in a Phase 1b clinical trial.

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 potential market size for TP-03, future events and Tarsus’ plans for and the anticipated benefits of its product candidates including TP-03, the timing, objectives and results of the clinical trials including the potential complete clinical results of the Saturn-2 trial, anticipated regulatory and development milestones 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, 2021 filed on March 14, 2022 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
akemp@tarsusrx.com

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

FAQ

What are the recent findings from Tarsus Pharmaceuticals regarding Demodex blepharitis?

Tarsus Pharmaceuticals recently presented findings indicating that patients with Demodex blepharitis face significant daily life impacts, with no effective FDA-approved treatments.

What is the significance of the Saturn-2 trial for Tarsus Pharmaceuticals?

The Saturn-2 trial is pivotal for TP-03, an investigational treatment for Demodex blepharitis, and is crucial for potential FDA approval.

What is TP-03 and how might it benefit patients with Demodex blepharitis?

TP-03 is an investigational ophthalmic solution targeting Demodex mites, aiming to provide a much-needed treatment option for millions affected by Demodex blepharitis.

When will Tarsus Pharmaceuticals share results from the Saturn-2 trial?

Tarsus Pharmaceuticals is preparing to share topline results from the Saturn-2 trial imminently, which is critical for TP-03's development.