The FDA has accepted Tarsus Pharmaceuticals’ New Drug Application (NDA) for TP-03, its therapy candidate designed to treat Demodex blepharitis
I need more info on TP-03.
TP-03 is a topical ophthalmic formulation of lotilaner 0.25% that targets and removes Demodex mite infestation—the root cause of Demodex blepharitis. (via)
What did clinical trials show?
The Saturn-1 and and Saturn-2 pivotal trials assessed the use of TP-03 in a combined total of more than 800 patients with mild to moderate Demodex blepharitis.
Both trials met their primary and secondary endpoints and had no significant adverse events. Less than 2% of patients reported installation site pain/burning/stinging, while most adverse events were mild with few that were moderate in severity.
For a more visual explanation of results from the latest pivotal trial, Saturn 2b/3, watch here.
What’s next?
The review process begins—and now we wait! The FDA’s Prescription Drug User Fee Act (PDUFA) target action date is August 25, 2023.
If approved, TP-03 would become the first FDA-approved therapy in the U.S. to treat Demodex blepharitis.