Tarsus Submits New Drug Application to the FDA for TP-03 for the Treatment of Demodex Blepharitis

Tarsus Pharmaceuticals, Inc. recently announced it has submitted a New Drug Application (NDA) to the US FDA for TP-03 (lotilaner ophthalmic solution, 0.25%) for the treatment of Demodex blepharitis. Demodex blepharitis is a highly prevalent eyelid margin disease that does not have any FDA-approved treatment options. The NDA submission includes the positive results from the two pivotal trials (Saturn-1 and Saturn-2) collectively involving more than 800 patients in which TP-03 met all endpoints and was well-tolerated.

“TP-03 is the first and only investigational therapy to meet all endpoints in Demodex blepharitis pivotal trials. This NDA submission is a significant milestone for Tarsus and most importantly, it provides hope to millions of Demodex blepharitis patients who have been living with this damaging disease,” said Bobby Azamian, MD, PhD, President and Chief Executive Officer of Tarsus. “We are profoundly grateful to the hundreds of patients, dedicated eye care professionals and team members who contributed to this NDA and we look forward to working closely with the FDA to potentially bring TP-03 to patients.”

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. Both trials also demonstrated that TP-03 was well-tolerated. The most common adverse event occurring at a frequency of >2% in TP-03 treated patients was instillation site pain/burning/stinging; and all adverse events were either mild or moderate. 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.

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 US 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.

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. 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.