Tarsus Pharmaceuticals just submitted an NDA for TP-03 (lotilaner ophthalmic solution, 0.25%) for the treatment of Demodex blepharitis.
What is TP-03?
It's an eye drop that targets the nervous system of the Demodex mite, causing paralysis and death.
Tell me about the clinical trials.
TP-03 was evaluated in two pivotal trials, Saturn-1 and Saturn-2, collectively involving more than 800 patients. In the trials, dosing was bid for 43 days, and both trials met the primary endpoint and all secondary endpoints.
Any adverse events?
The most common adverse event occurring at a frequency of more than 2% in TP-03–treated patients was instillation site pain/burning/stinging. All adverse events were either mild or moderate.
When could we prescribe this?
No word on the PDUFA date, but after an NDA is filed, it can take around 9 to 12 months for the FDA to make a decision. More to come.