Tarsus Presents Saturn-2 Pivotal Phase 3 Trial Data and Saturn-1 Extension Study Long-Term Safety Data

Tarsus Pharmaceuticals announced that the results from the Saturn-2 pivotal phase 3 trial of TP-03 (lotilaner ophthalmic solution, 0.25%) in Demodex blepharitis patients will be presented at the upcoming World Cornea Congress (WCC) VIII and the American Academy of Ophthalmology (AAO) 2022 annual meetings in Chicago. At WCC, Tarsus will also present new long-term safety data from the extension study for the Saturn-1 pivotal phase 2b/3 trial evaluating TP-03 for the treatment of Demodex blepharitis.

“We are delighted to present positive data from the Saturn-2 phase 3 trial to our ophthalmology colleagues, partners, and other industry leaders at these two important scientific forums,” Elizabeth Yeu, MD, Director and Chief Medical Advisor for Tarsus, said in a company news release. “Demodex blepharitis impacts more than 25 million eye care patients in the United States and has a significant impact on patients, yet it remains underdiagnosed. These meaningful results, as well as the long-term safety data from the Saturn-1 extension study, highlight TP-03 as a potential option to help patients overcome this burdensome disease.”

Tarsus recently submitted a new drug application (NDA) to the FDA for TP-03 including the Saturn-1 and Saturn-2 pivotal trial results, both of which met the primary endpoint and all secondary endpoints. There are currently no FDA-approved treatments for Demodex blepharitis.

The posters being shared at both conferences are listed below:

WCC VIII:

• Extended Observational Safety Trial to Evaluate the Long-Term Safety of Lotilaner Ophthalmic Solution, 0.25% for the Treatment of Demodex Blepharitis: Saturn-1 Extension Study; Lisa Nijm, M.D., J.D., et al.
   
• Safety & Efficacy of Lotilaner Ophthalmic Solution, 0.25% in Treating Demodex Blepharitis: Results of the Saturn-2, Pivotal, Phase 3 Trial; Elizabeth Yeu, M.D., et al.

AAO

• Safety and Efficacy of Lotilaner Ophthalmic Solution, 0.25%, in Treating Demodex Blepharitis: Results of the Saturn-2 Trial (Session ID PO058); Elizabeth Yeu, M.D., et al.

About TP-03

TP-03 (lotilaner ophthalmic solution, 0.25%) is a novel, investigational therapeutic designed to resolve the signs of Demodex blepharitis by targeting and eradicating the root cause of the disease – Demodex mite infestation. Lotilaner is a well-characterized agent that eradicates Demodex mites by selectively inhibiting the GABA-Cl channels. It is a highly lipophilic molecule, which may promote its uptake in the oily sebum of the eye lash follicles where the mites reside. TP-03 was evaluated in two pivotal trials collectively involving more than 800 patients. Both trials met the primary endpoint and all secondary endpoints, with statistical significance and no serious treatment-related adverse events. Most patients found TP-03 to be neutral to very comfortable. The most common treatment-related ocular adverse event occurring at a frequency of >2% in TP-03 treated patients was instillation site pain/burning/stinging; most adverse events were mild with few moderate in severity. If approved, TP-03 may offer treatment for millions of patients with Demodex blepharitis. TP-03 is now also being studied for the treatment of Meibomian Gland Disease in patients with Demodex mites.