As part of its third quarter earnings report, Tarsus Pharmaceuticals announced that the FDA has accepted the company's new drug application (NDA) for TP-03 for the treatment of Demodex blepharitis. The Prescription Drug User Fee Act (PDUFA) target action date 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.”