Tarsus submits NDA to the FDA for TP-03 for treatment of Demodex blepharitis

Tarsus Pharmaceuticals Inc. today announced that it has submitted a New Drug Application (NDA) to the FDA for TP-03 (lotilaner ophthalmic solution, 0.25%) for the treatment of Demodex blepharitis.

According to the company, 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.

Bobby Azamian, MD, PhD, president and CEO of Tarsus, pointed out in a news release that 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,” Azamian said in a statement. “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.”

According to the company, TP-03 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.

The company noted that 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.

Moreover, the company noted in its news release that 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.