TP-03 for Demodex blepharitis meets endpoints in pivotal trial
TP-03 met all primary and secondary endpoints in a phase 2b/3 trial and had no serious treatment-related adverse events or discontinuations in the treatment of Demodex blepharitis, according to a press release from Tarsus Pharmaceuticals.
The randomized, controlled, multicenter, double-masked pivotal Saturn-1 trial investigated the safety and efficacy of TP-03 (lotilaner ophthalmic solution 0.25%) in 421 patients aged 18 years or older with Demodex blepharitis. Patients had more than 10 collarettes on the upper eyelid, at least mild erythema of the upper eyelid margin, and at least 1.5 mites per lash on the upper and lower eyelids combined.
Eighty-one percent of patients achieved a “significant, clinically meaningful collarette cure,” consisting of a collarette grade of zero or one at day 43, compared with 23% of patients on vehicle (P < .0001). Twenty-three percent of patients had clinically significant collarette cure by day 8 compared with 11% on vehicle (P = .0003). In addition, 43% of patients achieved the primary endpoint of complete collarette cure, with a grade of zero, at day 43 compared with 7% on vehicle (P < .0001).
By day 15, the secondary endpoint of complete mite eradication was achieved, and at day 43, 68% of patients on TP-03 achieved mite eradication compared with 18% of patients on vehicle (P < .0001).
TP-03 demonstrated a similar safety profile as the vehicle group. No serious treatment-related adverse events or treatment-related adverse events leading to therapy discontinuation occurred. The most common adverse events were pain, burning or stinging at the site of instillation, which occurred in 11.8% of patients.
Tarsus anticipates topline results for Saturn-2 in the first quarter of 2022, the release said. If the second pivotal trial, which is underway, yields similar results, Tarsus expects to submit a new drug application to the FDA in 2022.
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