Topical drug for Demodex blepharitis shows positive phase 2b results
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Results from a phase 2b single-arm, open-label trial that showed use of TP-03 for Demodex blepharitis was safe and well-tolerated after 4 weeks of treatment with persisting effects for at least 90 days.
“Demodex mites, which infest the eyelash follicles, meibomian glands and sebaceous glands, are the most common ectoparasite found in humans,” Roberto Gonzalez-Salinas, MD, PhD, the principal investigator of the study, which was conducted at the Asociación para Evitar la Ceguera in Mexico City, said during his virtual ARVO presentation. “An analysis of almost 5,000 patients has shown Demodex as implicated in about 45% of blepharitis cases. In the U.S., this accounts for nearly 9 million Americans.”
TP-03 (Tarsus Pharmaceuticals) is a topical drug that targets the nervous system of the Demodex mite, killing the mites.
The phase 2b Mars study comprised patients with more than 10 collarettes of cylindrical dandruff present on the upper lid, mild to severe lid margin erythema and average Demodex density of 1.5 mites or more per lash. Patients received one drop in each eye twice daily for 28 days.
In this study, 15 patients showed significantly lower average Demodex from baseline to day 28 (2.28 vs. 0.14 mites per lash). This decrease was sustained through 90 days.
Cylindrical dandruff also decreased from an average grade of 3.07 at baseline to 0.79 at day 28, a 2-grade improvement on a 4-point scale, with sustained improvement through day 90 (P .003).
The treatment has shown consistent results across four phase 2 studies and nearly 100 treated patients, according to a press release from Tarsus.
“At 97% of visits, patients rated the drop as neutral to very comfortable,” Gonzales-Salinas said. “The study demonstrated that the use of TP-03 for 4 weeks was well-tolerated and showed promising efficacy in the treatment of Demodex blepharitis. My colleagues and I are excited for a possible new therapy that targets the underlying cause of the disease.”
TP-03 is currently being developed in a multidose, preserved formulation, and Tarsus expects to begin phase 3 trials this year, according to the release.
Editor’s Note: On Aug. 3, we corrected the lede of this article to clarify that the trial was a single-arm, open-label trial and data regarding the cylindrical dandruff grade improvement.
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Gonzalez-Salinas R, et al. Pilot study to evaluate the safety and efficacy of TP-03 for the treatment of blepharitis due to Demodex infestation (Mars study). Presented at: Association for Research in Vision and Ophthalmology meeting; May 6, 2020 (virtual meeting).
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