Demodex blepharitis, caused by infestation of Demodex mites, is characterized by collarettes, leading to eyelid itching/burning, blurred vision and negative impact on daily life. There are currently no FDA-approved therapies for Demodex blepharitis. Every year, about 2.1 million cases of blepharitis are reported in the U.S.
If all goes well, Tarsus Pharmaceuticals Inc. (TARS) could potentially be the first company to secure FDA nod for its Demodex blepharitis therapy. The product candidate in focus is TP-03, a topical formulation of active ingredient Lotilaner, currently under a phase III trial.
The phase III trial, dubbed Saturn-2, was initiated last May, and it completed enrollment with 408 patients in February of this year.
The primary endpoint is the proportion of patients achieving complete *collarette cure, defined as 0 to 2 collarettes per lid and secondary endpoints are mite eradication, lid margin erythema (redness) cure and a composite of collarette and erythema cures.
*Collarettes, or cylindrical dandruff, are an accumulation of mite waste product and eggs that form at the base of the eyelashes.
The company expects to report pivotal topline data from the Saturn-2 trial this month, which if positive could lead to a New Drug Application submission later this year.
TP-03 is also being explored for the treatment of meibomian gland dysfunction, a disorder in which the glands either do not secrete enough oil or secrete oil of low quality.
The company expects to initiate a phase IIa trial of TP-03 in meibomian gland dysfunction, dubbed Ersa, in the second half of this year.
Tarsus Pharma has two more investigational products in the pipeline, namely TP-04 for the treatment of Rosacea, and TP-05 for the treatment of Lyme disease and malaria.
— A phase IIa trial of TP-04 in rosacea, dubbed Galatea, is expected to be initiated in the second half of this year.
— A phase I trial of TP-05 for the prevention of Lyme disease, dubbed Callisto, initiated last June, is underway. Data from this trial is anticipated in the second half of this year.
Tarsus Pharma ended the year 2021 with cash, cash equivalents and marketable securities of $171.8 million.
Tarsus’ common stock began trading on the Nasdaq Global Select Market on October 16, 2020, priced at $16 per share.
TARS has traded in a range of $14.41 to $39.08 in the last 1 year. The stock closed Friday’s trading at $18.06, down 1.20%.
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