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# Tarsus Planning NDA for Parasitic Eye Disease
- URL: https://www.fdaweb.com/tarsus-planning-nda-for-parasitic-eye-disease/
- Published: 2021-06-21T12:00:00.000Z
- Updated: 2026-09-14T17:04:07.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149583

Tarsus Pharmaceuticals says it is planning an NDA submission next year after just reporting positive data from a Phase 2b/3 trial (Saturn-1) that evaluated the company’s novel investigational therapeutic, TP-03 (lotilaner ophthalmic solution, 0.25%), in patients with demodex blepharitis. The company says the highly prevalent ocular disease affects as many as 25 million Americans. It is caused by an infestation of demodex mites, the most common ectoparasite found on humans. Currently, there are no FDA approved therapies for the disease,

The company says the trial results demonstrated a “statistically significant complete collarette cure at day 43 in patients with Demodex blepharitis treated with TP-03 compared to vehicle.” The trial also met the secondary endpoints of mite eradication at day 43 and composite cure based on complete collarette and erythema cures at day 43\. Additionally, it says significant, clinically meaningful improvements were observed within two weeks across multiple endpoints. “TP-03 was well tolerated with a safety profile similar to vehicle, and there were no treatment-related discontinuations,” it adds.

Tarsus describes TP-03 as a topical ophthalmic formulation of lotilaner, which is a well-characterized anti-parasitic agent that paralyzes and eradicates Demodex mites by selectively inhibiting parasite-specific GABA-Cl channels.