Benzinga | Jun 21, 2021 06:04AM EDT

Tarsus Pharmaceuticals, Inc. Announces Positive Results of Saturn-1 Pivotal Trial Evaluating TP-03 for the Treatment of Demodex Blepharitis; Co. Reports 'Saturn-1 Phase 2b/3 trial met all primary and secondary endpoints'

Tarsus Pharmaceuticals, Inc. (NASDAQ:TARS), a late clinical-stage biopharmaceutical company whose mission is to focus on unmet needs and apply proven science and new technology to revolutionize treatment for patients, starting with eye care, today announced that all pre-specified primary and secondary endpoints were met for its pivotal Phase 2b/3 Saturn-1 trial evaluating the company's novel investigational therapeutic, TP-03 (lotilaner ophthalmic solution, 0.25%), in patients with Demodex blepharitis. Results demonstrated a statistically significant complete collarette cure at day 43 in patients with Demodex blepharitis treated with TP-03 compared to vehicle (p<0.0001; primary endpoint). The Saturn-1 trial also met the secondary endpoints of mite eradication at day 43 (p<0.0001) and composite cure based on complete collarette and erythema cures at day 43 (p<0.0001). In addition, 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.

"Millions of people are living with Demodex blepharitis, and we know from recent research that these patients are suffering daily. With no U.S. Food and Drug Administration (FDA)-approved therapies, both patients and eye care professionals need a solution to eradicate the mites that cause the disease," said Bobak Azamian, M.D., Ph.D., President and Chief Executive Officer of Tarsus. "We believe the results from our Saturn-1 trial mark an important moment in Demodex blepharitis research, showing the potential of TP-03 to target the underlying cause of this disease and potentially become the standard of care for patients and clinicians. We expect to provide topline results for our second pivotal trial for TP-03, Saturn-2, in Q1 of 2022. If Saturn-2 trial data is positive, similar to the positive Saturn-1 results, we expect both Saturn-1 and Saturn-2 trials to support our submission of a New Drug Application (NDA) for TP-03 for the treatment of Demodex blepharitis in 2022."

Demodex blepharitis is a highly prevalent ocular disease, affecting as many as 25 million Americans, that can have a significant clinical burden and negatively impact patients' daily lives. The disease is caused by an infestation of Demodex mites, the most common ectoparasite found on humans, that live on the skin of the face and eyelids. Demodex blepharitis is characterized by inflammation of the eyelid margin, redness and ocular irritation. TP-03 has the potential to be the first FDA-approved therapeutic for Demodex blepharitis and targets the underlying cause of disease -- Demodex mite infestation. The Saturn-1 trial is the first large-scale trial to show positive, clinically meaningful results for a therapeutic specifically designed to treat Demodex blepharitis.