Tarsus Pharmaceuticals, Inc. Presents New Saturn-1 Pivotal Trial Data and Titan Real-World Prevalence Study Results at ASCRS 2021 - Seite 2

Additional Saturn-1 Phase 2b/3 Results & Safety Data

New Saturn-1 data presented at ASCRS today, demonstrated that, in addition to achieving all primary and secondary endpoints, the results showed a strong patient responder rate, as nearly all Demodex blepharitis patients experienced a significant response to treatment with TP-03. These findings indicate the substantial potential impact this treatment may have for both patients and eye care professionals. Results showed meaningful improvement in the number of mites per lash as well as collarette grade reduction:

• 95% of TP-03 patients showed a significant response in mite count, achieving ≤0.5 mites per lash at day 43 from an average baseline of 3.2 mites per lash, compared to 36% of those on vehicle (p<0.0001), with statistically significant results seen as early as day 15.
• 93% of TP-03 patients improved by at least one collarette grade by day 43, from an average baseline of grade 2.8 or approximately 100 collarettes per lid, compared to 50% of those on vehicle (p<0.0001), with statistically significant results seen as early as day 8.

In addition to the data presented at the ASCRS meeting, Tarsus is also announcing results from additional Saturn-1 safety analysis, which revealed that TP-03 had no clinically significant effect on multiple safety measures including Corrected Distance Visual Acuity (CDVA), corneal staining, and intraocular pressure (IOP) and no significant findings from slit lamp biomicroscopy or fundus exam. In addition, no impact to endothelial cell density (ECD) was seen in a subset of 21 patients. ECD will be further evaluated as part of the Saturn-2 trial plan. Analysis from Saturn-1, along with previously announced data, reinforces that TP-03 is potentially safe to use in a broad patient population.

Saturn-1 (Phase 2b/3) was a randomized, controlled, multicenter, double-masked pivotal trial evaluating the safety and efficacy of TP-03 in adults with Demodex blepharitis. Previously announced Saturn-1 topline data showed that TP-03 met all its primary and secondary endpoints, including improvements in lid margin redness, with no serious treatment-related adverse events and no treatment-related discontinuations.

The Saturn-1 trial was the first pivotal large-scale trial to show positive, clinically meaningful and statistically significant patient improvements for a therapeutic specifically designed to treat Demodex blepharitis. TP-03 has the potential to be the first U.S. Food and Drug Administration (FDA)-approved therapeutic for Demodex blepharitis that targets the underlying cause of disease – Demodex mite infestation.