Tarsus Pharmaceuticals' TP-03 Hits Primary, Secondary Endpoints In Demodex Blepharitis Study

Tarsus Pharmaceuticals Inc TARS has reported topline data from Phase 2b/3 Saturn-1 trial evaluating TP-03 (lotilaner ophthalmic solution, 0.25%) in patients with Demodex blepharitis.
81% of patients achieved a significant, clinically meaningful collarette cure compared to 23% of those on the vehicle (primary endpoint).
Additionally, a significant, clinically meaningful collarette cure was seen in 23% of patients on TP-03 compared to 11% on the vehicle as early as day 8.
43% of patients on TP-03 achieved the primary endpoint of complete collarette cure (grade 0) at day 43, defined as zero to two (0-2) collarettes per lid compared to 7% on the vehicle.
Collarettes, a pathognomonic sign of Demodex infestation, are composed of partially digested epithelial cells, mite waste products, and eggs and are most easily observed at the base of the upper eyelashes.
The trial also met the secondary endpoints of mite eradication at day 43 and composite cure based on complete collarette and erythema cures.
TP-03 was well tolerated with a safety profile similar to the vehicle, and there were no treatment-related discontinuations.
The company is also conducting a second pivotal trial for TP-03, Saturn-2, with expected results in Q1 of 2022.
If Saturn-2 trial data is positive, the company will submit a TP-03 marketing application to the FDA in 2022.
The company will host a conference call, listen-only webcast today at 8:00 a.m. ET.
Blepharitis is a common ocular condition characterized by inflammation of the eyelid margin, redness, and ocular irritation.
Price Action: TARS shares closed at $34.81 on Friday.

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