Enrollment begins in phase 2a trial of TP-03 for meibomian gland dysfunction
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The first participant has been enrolled in a phase 2a clinical trial investigating TP-03 as a treatment for meibomian gland dysfunction in those with Demodex mites, according to a press release from Tarsus Pharmaceuticals.
TP-03 (lotilaner ophthalmic solution 0.25%) is designed to paralyze and eradicate Demodex mites that live in the meibomian glands by selectively inhibiting the GABA-Cl channels.
There are no FDA-approved pharmacologic treatments for meibomian gland dysfunction. In two pivotal trials of more than 800 subjects with Demodex blepharitis, TP-03 has been well tolerated and met all endpoints.
“We’re enthusiastic about expanding our therapeutic footprint in eye care as we evaluate TP-03 in another highly prevalent eyelid margin disease that has no FDA-approved pharmacologic therapies,” José Trevejo, MD, PhD, chief medical officer of Tarsus, said in the release. “We look forward to leveraging key learnings from our Saturn-1 and 2 trials where TP-03 demonstrated statistically significant efficacy in treating Demodex blepharitis with a favorable safety profile. We are eager to explore its potential to treat another important eye disease associated with the presence of Demodex mites.”
Tarsus expects to submit a new drug application for TP-03 to the FDA for the treatment of Demodex blepharitis later this year.
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