Benzinga | Jul 26, 2021 09:59AM EDT

Tarsus Pharma Late Saturday Highlighted Presentation Of New Saturn-1 Trial Data, Titan Real-World Prevalence Study Results At American Society of Cataract and Refractive Surgery Meeting

New Saturn-1 data demonstrated a strong patient responder rate with 95% of Demodex blepharitis patients treated with TP-03 achieving ?0.5 mites per lash and 93% improving by at least one collarette grade

Further Saturn-1 safety analysis revealed that TP-03 had a favorable safety profile with no clinically significant effect on multiple measures

Titan study reveals the high real-world prevalence of Demodex blepharitis, with collarettes present in 58% of U.S. patients visiting an eye doctor

IRVINE, Calif., July 24, 2021 (GLOBE NEWSWIRE) -- Tarsus Pharmaceuticals, Inc. (NASDAQ:TARS), a late clinical-stage biopharmaceutical company whose mission is to focus on unmet needs and apply proven science and new technology to revolutionize treatment for patients, starting with eye care, today announced new data from its Saturn-1 Phase 2b/3 pivotal trial and the Titan real-world collarette prevalence study at the American Society of Cataract and Refractive Surgery (ASCRS) 2021 Annual Meeting. The new Saturn-1 data reinforce the strong potential clinical utility of TP-03 (lotilaner ophthalmic solution, 0.25%) for the treatment of Demodex blepharitis, with a broad range of patients showing a substantial response. The Titan study revealed the high prevalence of Demodex blepharitis in all-comer eye care patients in the U.S. across diverse populations and geographies, including significant overlap with some of the most commonly seen patients, such as those taking prescription dry eye treatments.

"We are very encouraged by the additional Saturn-1 data points, demonstrating that nearly all patients experienced a substantial response, and the clinical value that TP-03 may have for both patients and eye care professionals who have long struggled to manage Demodex blepharitis -- a disease with no existing approved therapies," said Bobak Azamian, M.D., Ph.D., President and Chief Executive Officer of Tarsus. "We have received a lot of enthusiasm and positive feedback on this new data from clinicians at the ASCRS meeting. The compelling results of the Saturn-1 trial mark an important step in our clinical program for TP-03 and bring us one step closer to the development of a much-needed therapy for patients suffering from this disease. Our second pivotal trial, Saturn-2 is currently enrolling. If the topline results expected in Q1 2022 are positive, we expect to submit a New Drug Application next year for TP-03 for the treatment of Demodex blepharitis."

Additional Saturn-1 Phase 2b/3 Results & Safety Data

New Saturn-1 data presented at ASCRS today, demonstrated that, in addition to achieving all primary and secondary endpoints, the results showed a strong patient responder rate, as nearly all Demodex blepharitis patients experienced a significant response to treatment with TP-03. These findings indicate the substantial potential impact this treatment may have for both patients and eye care professionals. Results showed meaningful improvement in the number of mites per lash as well as collarette grade reduction:

* 95% of TP-03 patients showed a significant response in mite count, achieving ?0.5 mites per lash at day 43 from an average baseline of 3.2 mites per lash, compared to 36% of those on vehicle (p<0.0001), with statistically significant results seen as early as day 15.

* 93% of TP-03 patients improved by at least one collarette grade by day 43, from an average baseline of grade 2.8 or approximately 100 collarettes per lid, compared to 50% of those on vehicle (p<0.0001), with statistically significant results seen as early as day 8.

In addition to the data presented at the ASCRS meeting, Tarsus is also announcing results from additional Saturn-1 safety analysis, which revealed that TP-03 had no clinically significant effect on multiple safety measures including Corrected Distance Visual Acuity (CDVA), corneal staining, and intraocular pressure (IOP) and no significant findings from slit lamp biomicroscopy or fundus exam. In addition, no impact to endothelial cell density (ECD) was seen in a subset of 21 patients. ECD will be further evaluated as part of the Saturn-2 trial plan. Analysis from Saturn-1, along with previously announced data, reinforces that TP-03 is potentially safe to use in a broad patient population.

Saturn-1 (Phase 2b/3) was a randomized, controlled, multicenter, double-masked pivotal trial evaluating the safety and efficacy of TP-03 in adults with Demodex blepharitis. Previously announced Saturn-1 topline data showed that TP-03 met all its primary and secondary endpoints, including improvements in lid margin redness, with no serious treatment-related adverse events and no treatment-related discontinuations.

The Saturn-1 trial was the first pivotal large-scale trial to show positive, clinically meaningful and statistically significant patient improvements for a therapeutic specifically designed to treat Demodex blepharitis. TP-03 has the potential to be the first U.S. Food and Drug Administration (FDA)-approved therapeutic for Demodex blepharitis that targets the underlying cause of disease -- Demodex mite infestation.

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:

* Safety and Efficacy of Topical Lotilaner, 0.25% for the Treatment of Demodex Blepharitis: Results of the Phase 2b/3 Saturn-1 Trial

* The Prevalence of Collarettes and Demodex Blepharitis in Ophthalmology and Optometry Practices