Benzinga | Dec 23, 2020 07:06AM EST

Tarsus Pharma Reports Type C Meeting With FDA Related To New Drug Application Submission Requirements For TP-03

Tarsus Pharmaceuticals, Inc. (NASDAQ:TARS), a late clinical-stage biopharmaceutical company whose mission is to discover and deliver breakthrough treatments to transform the lives of patients with common and poorly treated diseases, starting with the eye, today announced that it received written minutes from the (Type C) meeting held on December 8 with the United States Food and Drug Administration (FDA). The meeting was held to align on specific NDA submission requirements for TP-03, a novel therapeutic in development for the treatment of Demodex blepharitis, and the Company believes it received collaborative and productive guidance.

"Recently, we held a productive Type C meeting with the FDA. At this meeting, we obtained valuable feedback on the data requirements for an NDA filing consistent with our existing plans: specifically, regarding the non-clinical toxicology, clinical and CMC components," said Sesha Neervannan, COO of Tarsus. "We are pleased to continue advancing TP-03 through its pivotal trials and towards a potential NDA filing in order to provide the more than 9 million people in the United States that suffer from Demodex blepharitis a potential therapeutic treatment option."

Recently, Tarsus completed its Io and Europa Phase 2 clinical trials, and began enrolling patients in Saturn-1, its Phase 2b/3 pivotal trial. The company plans to initiate its second pivotal registration trial, Saturn-2, in 2021, and expects for the data to support the potential submission of an NDA for TP-03 to treat Demodex blepharitis. TP-03 has the potential to be the first FDA-approved therapeutic and standard of care for the treatment of Demodex blepharitis.