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FDA Accepts Tarsus' NDA for TP-03 for Treatment of Demodex Blepharitis

FDA Accepts Tarsus' NDA for TP-03 for Treatment of Demodex Blepharitis

November 10, 2022

The FDA has approved Tarsus Pharmaceuticals' new drug application (NDA) for TP-03, a therapy for Demodex blepharitis, the company stated in its third quarter financial report. The target action date for the Prescription Drug User Fee Act (PDUFA) is August 25, 2023.

Tarsus also announced the launch of a disease education program, a field medical team, and payor engagement in anticipation of the TP-03 launch.

“During 2022, we moved significantly closer to delivering a new potential drug to millions of patients suffering from one of the most common eye diseases, Demodex blepharitis. The NDA acceptance for TP-03 is a critical milestone for Tarsus, patients and the eye care professionals who treat them as we move closer toward potential commercialization. In parallel, we initiated a robust disease education program and launched our field medical team to continue to drive awareness and encourage eye care professionals to diagnose this highly prevalent disease,” Bobak Azamian, MD, PhD, President and Chief Executive Officer of Tarsus, said in a company news release.

“We also advanced our pipeline with the start of an exploratory Phase 2a study in MGD and are on-track to initiate a phase 2a study in Lyme disease prevention this quarter. As we look to 2023 and beyond, we are well capitalized with the financial resources we need to continue investing in our priorities to deliver innovative drugs to patients and further drive shareholder value and growth,” Bobak Azamian added.

What is TP-03?

TP-03 is a topical ophthalmic formulation of lotilaner that, if approved, may offer treatment for millions of patients with Demodex blepharitis. It is designed to resolve the signs of Demodex blepharitis by targeting and eradicating the root cause of the disease–Demodex mite infestation. TP-03 paralyzes and eradicates Demodex mites by selectively inhibiting parasite-specific GABA-Cl channels.

Evaluated in 2 pivotal trials collectively involving 833 patients, both of which successfully met all primary and secondary end points; TP-03 had no serious treatment-related adverse events and was generally safe and well tolerated. TP-03 may potentially become the first FDA-approved therapy and definitive standard of care to treat millions of patients with Demodex blepharitis, if approved.