Tarsus Pharmaceuticals has announced positive results for its Phase 2a Mars Study, demonstrating tolerance and promising efficacy for ophthalmic drug TP-03 in the treatment of Demodex Blepharitis. Four weeks of treatment showed persistent effects lasting at least 90 days. Results of a Phase 2b randomized controlled study will also be released later this month.
TP-03 is a novel, topical ophthalmic drug that specifically targets the nervous system of Demodex mites, the underlying cause of Demodex Blepharitis. Mars is a single-arm, open-label study to evaluate the safety and efficacy of TP-03 in 15 participants with Demodex Blepharitis.
The prespecified efficacy endpoints were improvement in collarette score and mite density. Participants dosed one drop of TP-03 in each eye BID for 28 days. Results showed statistically significant decreases in mean collarette score and mite density beginning at day 14 and continuing throughout the study period of 90 days with no adverse events reported.
"We are excited that TP-03 has shown rapid, complete, and durable efficacy across both measures with a tolerable and safe eyedrop," said Tarsus CEO Bobak Azamian, MD, PhD. "These results are the beginning of a strong, consistent data set we are generating with TP-03 to treat the underlying cause of Demodex Blepharitis and other conditions."
Tarsus will release results of the Jupiter Study, a Phase 2b Randomized Controlled Trial to Evaluate the Safety and Efficacy of TP-03 for the Treatment of Demodex Blepharitis at the American Optometric Association's virtual meeting on June 26 at 12:30 pm EDT. The company plans to file an IND for TP-03 to treat Demodex Blepharitis and begin a Phase 3 trial later this year. Its clinical pipeline also includes studies in meibomian gland disease (MGD) and rosacea.
Full news release: https://www.tarsusrx.com/news