Tarsus Pharmaceuticals, Inc. is a late clinical-stage biopharmaceutical company whose mission is to focus on unmet needs and apply proven science and new technology to revolutionize treatment for patients, starting with eye care. Tarsus was founded in 2017 and has built a relationship with Octane from the start. Last year, Tarsus won an Octane High Tech Award for ‘Deal of the Year’, recognizing the company’s Series B financing in 2019, which was then followed by a successful initial public offering (IPO) in October 2020. Tarsus’ co-founder, Bobak Azamian, M.D., Ph.D., President and Chief Executive Officer of Tarsus, has a long history with Octane and his early involvement led him to Visionary Ventures, which became an early investor in Tarsus during the Series B round.
Headquartered in Irvine, Tarsus is quickly advancing its lead product candidate for the treatment of Demodex blepharitis, which was bolstered by the announcement of positive Phase 2b/3 results from the pivotal Saturn-1 trial last month.
Targeting Demodex Blepharitis
As many as 25 million Americans may suffer from Demodex blepharitis, a common ocular condition that is characterized by inflammation of the eyelid margin, redness and ocular irritation. There is currently no FDA-approved therapy for the disease, which is caused by an infestation of Demodex mites, the most common ectoparasite found on humans. The presence of collarettes, or cylindrical dandruff, is the pathognomonic sign of the disease and is most easily observed at the base of the upper eyelashes when a patient looks down during a slit lamp exam.
Patient at Slit Lamp Looking Straight Ahead (L) and Looking Down (R)
“Although highly prevalent, Demodex blepharitis is often overlooked or misdiagnosed due to comorbid conditions and overlapping symptoms with other ocular surface diseases and – as a result – patients may struggle with the condition for years,” said Dr. Azamian.
The pioneering Atlas study revealed Demodex blepharitis has a significant clinical, functional and psychosocial burden, negatively affecting daily life in the majority (80%) of patients surveyed. Tarsus is advancing its novel investigational therapeutic, TP-03, to potentially help these patients by addressing the underlying cause of disease.
TP-03 is a topical ophthalmic formulation of lotilaner, a well-characterized anti-parasitic agent designed to target and eradicate Demodex mites. The recently completed Saturn-1 Phase 2b/3 pivotal trial of TP-03 to treat Demodex blepharitis met all primary and secondary endpoints, and demonstrated significant, clinically meaningful outcomes with no serious treatment-related adverse events and no treatment-related discontinuations. The study also showed statistically significant improvement in eyelid redness, which is a key sign of inflammation. If results for the pivotal Phase 3 Saturn-2 trial are similarly positive, Tarsus expects to submit a New Drug Application (NDA) to the FDA for TP-03 for the treatment of Demodex blepharitis.
Saturn-1 participant collarettes at baseline (Day 0, Grade 4) and post treatment (Day 43, Grade 0).
A Pipeline to Help Patients in Need
Patients come first as Tarsus looks for new ways to apply proven science to address highly prevalent diseases. While Tarsus is focused on eye care with TP-03, which is also being developed for meibomian gland disease (MGD), the company is also looking to address other diseases with high unmet needs through its pipeline, including dermatology and infectious disease prevention.
Last month, Tarsus initiated a Phase 1 trial of TP-05, an oral, non-vaccine therapeutic for the prevention of Lyme disease and is also exploring TP-05 for potential community malaria reduction.
Meet the Tarsus Team
The Tarsus leadership team has extensive and broad experience across biopharmaceuticals, medical device, and eye care.
Key leadership team members also play an active role in Octane.
Bobak Azamian, M.D., Ph.D., President and Chief Executive Officer of Tarsus, was on Octane’s Board of Directors from June 2012 to May 2021 and is a speaker in the Ignite series. Tune into his discussion, “Scaling Your Company for Rapid Growth” on August 6th at 10:30 a.m. Register here:
Aziz Mottiwala, Chief Commercial Officer of Tarsus, currently serves on the Octane Board of Directors and is a panelist at the upcoming Ophthalmology Tech Summit, July 8-10 in Newport Beach, CA.
Tarsus now has more than 30 employees and looks forward to growing their presence in Irvine, California as part of the innovation ecosystem in Orange County that Octane helps to support.