Tarsus to Present Saturn-2 Pivotal Phase 3 Trial Data and Saturn-1 Extension Study Long-Term Safety Data Evaluating TP-03 for the Treatment of Demodex Blepharitis at Upcoming Eye Care Meetings

Rhea-AI Summary

Tarsus Pharmaceuticals (NASDAQ: TARS) announced the upcoming presentation of positive data from the pivotal Phase 3 Saturn-2 trial of TP-03 at the World Cornea Congress VIII and AAO 2022. The company has submitted a New Drug Application (NDA) to the FDA, supported by favorable results from the Saturn-1 and Saturn-2 trials, which met primary and secondary endpoints. With no FDA-approved treatments for Demodex blepharitis currently available, TP-03 represents a significant advancement in addressing a condition affecting over 25 million patients in the U.S.

Positive

• TP-03 met primary and secondary endpoints in both the Phase 2b/3 and Phase 3 trials.
• TP-03 has the potential to address a significant market need with over 25 million affected patients.
• Long-term safety data presented at the conferences demonstrates promise for TP-03.

Negative

• None.

Positive data to be presented at WCC VIII and AAO 2022 conferences in Chicago

Tarsus recently submitted NDA to the FDA for TP-03

IRVINE, Calif., Sept. 27, 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, today announced that the results from the Saturn-2 pivotal Phase 3 trial of TP-03 (lotilaner ophthalmic solution, 0.25%) in Demodex blepharitis patients will be presented at the upcoming World Cornea Congress (WCC) VIII and the American Academy of Ophthalmology (AAO) 2022 Annual Meetings in Chicago, Illinois. At WCC, Tarsus will also present new long-term safety data from the extension study for the Saturn-1 pivotal Phase 2b/3 trial evaluating TP-03 for the treatment of Demodex blepharitis.

“We are delighted to present positive data from the Saturn-2 Phase 3 trial to our ophthalmology colleagues, partners, and other industry leaders at these two important scientific forums,” said Elizabeth Yeu, M.D., Director and Chief Medical Advisor for Tarsus. “Demodex blepharitis impacts more than 25 million eye care patients in the United States and has a significant impact on patients, yet it remains underdiagnosed. These meaningful results, as well as the long-term safety data from the Saturn-1 extension study, highlight TP-03 as a potential option to help patients overcome this burdensome disease.”

Tarsus recently submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for TP-03 including the Saturn-1 and Saturn-2 pivotal trial results, both of which met the primary endpoint and all secondary endpoints. There are currently no FDA-approved treatments for Demodex blepharitis.

The posters being shared at both conferences are listed below:

WCC VIII:

• Extended Observational Safety Trial to Evaluate the Long-Term Safety of Lotilaner Ophthalmic Solution, 0.25% for the Treatment of Demodex Blepharitis: Saturn-1 Extension Study; Lisa Nijm, M.D., J.D., et al.
  
  
• Safety & Efficacy of Lotilaner Ophthalmic Solution, 0.25% in Treating Demodex Blepharitis: Results of the Saturn-2, Pivotal, Phase 3 Trial; Elizabeth Yeu, M.D., et al.
  

AAO

• Safety and Efficacy of Lotilaner Ophthalmic Solution, 0.25%, in Treating Demodex Blepharitis: Results of the Saturn-2 Trial (Session ID PO058); Elizabeth Yeu, M.D., et al.
  

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 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 eye lash follicles where the mites reside. TP-03 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 TP-03 to be neutral to very comfortable. The most common treatment-related ocular adverse event occurring at a frequency of >2% in TP-03 treated patients was instillation site pain/burning/stinging; most adverse events were mild with few moderate in severity. If approved, TP-03 may offer treatment for millions of patients with Demodex blepharitis. TP-03 is now also being studied for the treatment of Meibomian Gland Disease in patients with Demodex mites.

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 negative impact on 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. 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 two investigational medicines in clinical trials. Its lead product candidate, TP-03, is a novel therapeutic which has demonstrated positive results in two pivotal trials for the treatment of Demodex blepharitis. TP-03 is also being developed for the treatment of Meibomian Gland Disease, and currently being studied in a Phase 2a clinical trial. 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 and TP-05, the timing, objectives and results of the clinical trials, anticipated regulatory and development milestones, and the quotations of Tarsus’ management and directors. 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 and the most recent Form 10-Q quarterly filing filed with the SEC on August 11, 2022, each of 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 is the purpose of the TP-03 clinical trials?

TP-03 is being evaluated for its efficacy in treating Demodex blepharitis, a disease affecting millions of patients.

What were the results of the Saturn-2 trial for TP-03?

The Saturn-2 trial met all primary and secondary endpoints, demonstrating positive results for treating Demodex blepharitis.

When will the results of these trials be presented?

Results from the Saturn-2 trial will be presented at the World Cornea Congress VIII and AAO 2022 conferences.

What is the significance of the NDA submitted for TP-03?

The NDA submission is a critical step toward making TP-03 available as the first FDA-approved treatment for Demodex blepharitis.

What implications do the trial results have for Tarsus Pharmaceuticals and its investors?

Positive trial results could lead to regulatory approval and potential market entry, positively impacting Tarsus's stock performance.