Enrollment begins in phase 2a trial of TP-03 for meibomian gland dysfunction

The first participant has been enrolled in a phase 2a clinical trial investigating TP-03 as a treatment for meibomian gland dysfunction in those withDemodexmites, according to a press release from Tarsus Pharmaceuticals.

TP-03 (lotilaner ophthalmic solution 0.25%) is designed to paralyze and eradicateDemodexmites that live in the meibomian glands by selectively inhibiting the GABA-Cl channels.

There are no FDA-approved pharmacologic treatments for meibomian gland dysfunction. Intwo pivotal trialsof more than 800 subjects withDemodexblepharitis, 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 treatingDemodexblepharitis with a favorable safety profile. We are eager to explore its potential to treat another important eye disease associated with the presence ofDemodexmites.”

Tarsus expects to submit a new drug application for TP-03 to the FDA for the treatment ofDemodexblepharitis later this year.