Tarsus initiates Phase 2a ERSA trial evaluating TP-03 for treatment of meibomian gland disease

Tarsus Pharmaceuticals Inc. this week announced that it has enrolled the first patient in a Phase 2a clinical trial studying TP-03 (lotilaner ophthalmic solution, 0.25%) for the treatment of meibomian gland disease (MGD) in patients diagnosed with Demodex mites.

Demodex mites live in the meibomian glands and have been associated with microstructural glandular changes that can result in inflammation. Currently, there are no FDA approved pharmacologic treatments for MGD. TP-03 has been evaluated in two pivotal trials collectively involving more than 800 patients with Demodex blepharitis where it met the primary endpoint and all secondary endpoints and was well-tolerated.

According to a news release, Tarsus said it plans to submit a New Drug Application (NDA) to the FDA for TP-03 for the treatment of Demodex blepharitis in the second half of 2022.

“We’re enthusiastic about expanding our therapeutic footprint in eye care, as we evaluate TP-03 in another highly prevalent eyelid margin disease that has no FDA approved pharmacologic therapies,” José Trevejo, MD, PhD, chief medical officer of Tarsus, said in the news release. “We look forward to leveraging key learnings from our Saturn-1 and 2 trials where TP-03 demonstrated statistically significant efficacy in treating Demodex blepharitis with a favorable safety profile. We are eager to explore its potential to treat another important eye disease associated with the presence of Demodex mites.”

The meibomian glands line the eyelid margin and are responsible for secreting lipids that make up the superficial lipid layer of the tear film and prevent tears from evaporating. MGD occurs when the glands are not producing enough lipids, or the lipids they secrete are of poor quality. MGD is highly prevalent and thought to be the leading cause of dry eye disease, impacting approximately 2/3 of the 34 million patients with dry eye disease in the U.S. Patients with MGD experience symptoms of eye irritation and inflammation and when left untreated, may experience permanent changes to the tear film and progressive gland loss.

About TP-03
According to the company, TP-03 (lotilaner ophthalmic solution, 0.25%) is a novel, investigational therapeutic designed to resolve the signs of Demodexblepharitis 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 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 generally safe and well-tolerated.

The company noted that if approved, TP-03 may offer treatment for millions of patients with Demodexblepharitis. TP-03 is now also being studied for the treatment of MGD in patients with Demodex mites.