Tarsus to Present Additional Saturn-2 Pivotal Phase 3 Trial Data at the American Academy of Optometry 2022 Annual Meeting

Tarsus Pharmaceuticals announced that additional efficacy 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 American Academy of Optometry 2022 Annual Meeting in San Diego, California.

Additionally, data from an investigator-initiated study evaluating a potential correlation between meibomian gland atrophy and collarettes, the pathognomonic sign of Demodex blepharitis, will be presented.

“We are encouraged by the strong and consistent data from our Saturn-2 pivotal phase 3 trial, which further demonstrates the potential of TP-03, if approved, in treating Demodex blepharitis,” said José Trevejo, MD, PhD, Chief Medical Officer of Tarsus. “Additionally, new research studying a potential correlation between Demodex blepharitis and meibomian gland atrophy underscores the importance of Demodex as a contributing factor to meibomian gland disease.”

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

The posters being presented at the meeting are listed below:

• Safety & Efficacy of Lotilaner Ophthalmic Solution, 0.25% in Treating Demodex Blepharitis Results of the Phase III Saturn-2 Trial; Paul Karpecki, O.D., et al. 
  • Date: Thursday, October 27, 2022, 4:30-6:30 p.m. PT
  • Location: Poster Board #35
• Meibomian Gland Atrophy in Patients with Demodex Blepharitis; Cecelia Koetting, O.D., Elizabeth Yeu, M.D. 
  • Date: Friday, October 28, 2022, 1:00-3:00 p.m. PT
  • Location: Poster Board #124

Tarsus’ Chief Commercial Officer, Aziz Mottiwala, will also participate in the American Academy of Optometry’s 2022 virtual press conference to discuss the TP-03 pivotal trial results and the company’s Demodex blepharitis educational campaign. The virtual press conference will be on Tuesday, October 25, 5:00-7:00 p.m. PT and is accessible via the following link:
https://vimeo.com/optometry/2022aaopressconference