- 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.
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
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