224 0 Kommentare Tarsus Pharmaceuticals, Inc. Presents New Saturn-1 Pivotal Trial Data and Titan Real-World Prevalence Study Results at ASCRS 2021 - Seite 3

Tarsus is currently proceeding with the second pivotal trial, the Saturn-2 (Phase 3) trial, which has the same primary and secondary endpoints as Saturn-1 and is expected to report topline data results in Q1 2022.

Titan Study Results

The Titan study is an IRB-approved, retrospective chart review of 1,032 patients across six U.S.-based ophthalmology and optometry practices by seven investigators, designed to better understand the prevalence of collarettes in U.S. eye care clinics. Collarettes, or cylindrical dandruff, are a pathognomonic sign of Demodex blepharitis and are an accumulation of mite waste product and eggs that form at the base of the eyelashes. In data presented at ASCRS, the Titan study revealed the presence of collarettes in 58% (n=595) of patients. These results indicate a high prevalence of Demodex blepharitis across diverse patient populations and geographies. The study also revealed that the prevalence of Demodex blepharitis is similar to that of dry eye (58%, n=593).

“The Titan findings are significant and help to quantify how prevalent Demodex blepharitis is in real-life clinical practice, with more than half of observed patients presenting with collarettes,” said Ehsan Sadri, M.D., FACS, CEO and Founder of Visionary Eye Institute, Newport Beach and Titan study presenter at ASCRS. “The study also showed that collarettes are easy to identify through a close evaluation of the upper eyelid when patients are looking down during an eye exam. I look forward to the potential of a new, effective treatment option that can provide relief for this disease which impacts so many of my patients.”

The Titan study also found that most blepharitis patients (69%) had collarettes, underscoring the role that Demodex mites play in blepharitis cases. Additionally, 60% (n=135) of patients who were on a dry eye prescription also had collarettes. Analysis of these data suggest that these patients may have concomitant disease or that Demodex blepharitis may be the root cause or an exacerbating factor of their dry eye disease.

The Titan study findings are further supported by a prospective independent study presented at ARVO 2021 (Teo et al), which found that demodicosis was newly diagnosed in 55.3% of patients, with 61.8% and 68.3% noted to have blepharitis and dry eye, respectively.

Archived videos of the ASCRS presentations can be accessed via the following links: