Tarsus Pharmaceuticals Presents Data from Two Studies on the Prevalence and Impact of Demodex Blepharitis

Tarsus Pharmaceuticals presented data today from two pioneering studies on the prevalence and impact of Demodex blepharitis at the American Academy of Optometry (AAOpt) 2021 Annual Meeting in Boston. The Titan real-world prevalence study data revealed that Demodex blepharitis accounts for over two-thirds (69%) of all blepharitis cases and is present in many commonly seen patient groups. Additionally, new data revealed a high prevalence of collarettes in patient populations using TTO (75%) and lid wipes (57%), indicating that current management tools for this disease are largely ineffective.

There are currently no FDA approved therapeutics for Demodex blepharitis. Tarsus’ lead investigational candidate, TP-03 (lotilaner ophthalmic solution, 0.25%), is currently being evaluated in the Saturn-2, Phase 3, pivotal trial for the treatment of Demodex blepharitis. TP-03 was previously evaluated in the Saturn-1, phase 2b/3, pivotal trial involving 421 patients. Saturn-1 showed that TP-03 cleared the signs of Demodex blepharitis, met all primary and secondary endpoints with no serious treatment-related adverse events and was well-tolerated. Results from the Saturn-2, phase 3, pivotal trial are anticipated in Q1 of 2022.

“Data from the Titan and Atlas studies provide optometrists with important insights into the prevalence and negative impact Demodex blepharitis can have on patients, as well as the limitations of current management tools,” Bobak Azamian, MD, PhD, President and Chief Executive Officer of Tarsus, said in a company news release. “We know that optometrists are often on the frontlines of diagnosing this disease, as they are the first point of contact for many patients undergoing eye exams. We hope that sharing these findings will encourage them to continue to proactively identify the disease before it can have long-term negative impacts. These data also underscore the critical need for an effective solution for the treatment of this disease and we look forward to progressing the development of our of lead investigational candidate, TP-03, which – if FDA-approved – could become the standard of care for patients with Demodex blepharitis.”

New Titan Study Data 

The Titan study was an IRB-approved, retrospective chart review of 1,032 patients across six U.S.-based ophthalmology and optometry practices conducted by seven investigators. The study was designed to better understand the prevalence of Demodex blepharitis via collarettes in U.S. eye care clinics. Collarettes are a pathognomonic sign of Demodex blepharitis and are an accumulation of epithelial cells, keratin, mite waste product and eggs that form at the base of the eyelashes. The Titan study revealed that 58% of patients visiting eye care clinics for any reason had Demodex blepharitis, as evidenced by the presence of collarettes.

The new Titan data analysis demonstrates that Demodex blepharitis accounts for over two-thirds (69%) of all blepharitis cases and is present in many commonly seen patient populations. The new analysis showed a high collarette prevalence among eye care patients with glaucoma (65%), those taking a dry eye prescription treatment (60%), those with cataracts (56%) and among contact lens users (51%). The data also showed a high prevalence of collarettes among patients using TTO (75%) and lid wipes (57%) to manage their disease. These new data demonstrate that commonly used eye care treatments, even those used to manage blepharitis, are not effective at treating Demodex blepharitis.

“The Titan study demonstrates that Demodex blepharitis accounts for the majority of clinical blepharitis cases,” said Paul Karpecki OD, FAAO, Director of Cornea Services at Kentucky Eye Institute in Lexington, KY and Associate Professor at the Kentucky College of Optometry in Pikeville, KY, and Titan study presenter. “Given the high collarette prevalence in many patient groups, it is important that all optometrists have patients look down during a standard slit lamp exam to check for the presence of collarettes on the eyelashes during each routine patient visit. I look forward to having a potential treatment option that can effectively provide relief for so many of my patients.”

Atlas Study Data 

The Atlas study was the first multicenter observational study to evaluate the impact of Demodex blepharitis. The study surveyed 311 patients who were pre-screened at eight sites participating in the pivotal phase 2b/3 Saturn-1 trial evaluating the safety and efficacy of TP-03 in adults with Demodex blepharitis. Patients who had three objective signs of Demodex blepharitis, including the presence of Demodex mites, collarettes and lid margin redness, were asked questions about their ocular symptoms, diagnoses, and history, and their questionnaire responses were analyzed. The Atlas study showed that Demodex blepharitis is associated with a significant symptomatic and psychosocial burden, negatively affecting daily life in 80% of patients with the disease.

The study found that the considerable burdens of Demodex blepharitis led patients to seek treatment and medical care, mostly unsuccessfully:

• More than half of patients (51%) reported suffering from signs and symptoms of this disease for more than four years, having been to their eye doctor several times with no resolution, but most patients (58%) reported they had never been diagnosed with blepharitis.
• The most common symptoms reported were itchy eyes (55%) and dry eyes (46%).
• Many patients said they were emotionally affected – almost half (47%) reported being conscious of their eyes all day, nearly a quarter (23%) were constantly worried about their eyes and 23% said it gave their eyes or eyelids a negative appearance to others.
• The study also showed that the disease affected daily activities – almost half (47%) reported difficulty driving at night, nearly a third (30%) said it added time to their daily hygiene routine, and 34% of women reported difficulty wearing makeup.