Tarsus Pharma on track for NDA filing for eye treatment

 

• Tarsus Pharmaceuticals (NASDAQ:TARS) announces that it has received the written minutes of the (Type C) meeting held on December 8 with the FDA on specific NDA submission requirements for TP-03.
• NDA relates to TP-03 as a treatment for Demodex blepharitis, a common ocular condition with 45% or 9M cases in the US caused by Demodex mites. Currently, it has no FDA-approved treatments.
• TP-03, an ophthalmic solution, has completed four Phase 2 clinical trials in Demodex blepharitis, with all meeting their respective endpoints. The company has started enrolling patients in Saturn-1, a Phase 2b/3 pivotal trial, with plans to initiate the second pivotal registration trial, Saturn-2, in 2021. 
• Confirming that the feedback received on the data requirements for an NDA filing was consistent with its existing plans for clinical development for TP-03, Sesha Neervannan, COO of Tarsus, said: “We are pleased to continue advancing TP-03 through its pivotal trials and towards a potential NDA filing.”
• Tarsus Pharma made its market debut in October, raising $91.7M as net proceeds.
• https://seekingalpha.com/news/3646932-tarsus-pharma-is-on-track-for-nda-filing-for-eye-treatment