Demodex blepharitis is a common ocular condition that may affect up to 25 million Americans
Atlas study shows that Demodex blepharitis negatively impacts daily life for 80 percent of patients
Tarsus also presents complete efficacy and safety data from Phase 2b Europa trial, positive trial results used as the basis for the Saturn-1 & 2 pivotal trials
IRVINE, Calif., May 03, 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 data from its Demodex blepharitis clinical program presented at the virtual Association for Research in Vision and Ophthalmology (ARVO) 2021 Annual Meeting. Demodex blepharitis is a common ocular disease that may affect as many as 25 million Americans and has both clinical and psychosocial impacts. Characterized by inflammation of the eyelid margin, redness and ocular irritation, Demodex blepharitis is caused by an infestation of Demodex mites. Currently, there is no FDA-approved therapy for the disease. Tarsus’ lead product candidate, TP-03, is a topical ophthalmic formulation of lotilaner, a well-characterized anti-parasitic agent, designed to target and eradicate Demodex mites, and is currently being evaluated in the pivotal Phase 2b/3 Saturn-1 trial.
Although highly prevalent, Demodex blepharitis is often overlooked or misdiagnosed and – as a result – patients may struggle with the condition for years. Until now, the psychosocial effects of Demodex blepharitis have been poorly characterized. The Atlas study is the first multi-center observational study to evaluate the functional and psychosocial impact of the disease, along with clinical manifestations, in adult patients. Overall, the study showed that Demodex blepharitis is associated with a significant symptomatic and psychosocial burden, negatively affecting daily life in the majority (80%) of patients with the disease.
“The results from the Atlas study are significant because they demonstrate that there are severe functional and psychosocial impacts related to Demodex blepharitis with regard to routine, everyday activities and overall quality of life,” said Elizabeth Yeu, M.D., Chief Medical Advisor for Tarsus. “The study underscores the importance of identifying the disease sooner, as well as the need for a safe, effective therapy that may provide substantial relief to this patient population. Tarsus is committed to progressing their clinical program in this area to develop a therapy that may address the underlying cause of Demodex blepharitis.”
The Atlas study surveyed 311 patients who were pre-screened at 8 sites participating in Tarsus’ pivotal Phase 2b/3 Saturn-1 trial. Patients had three objective signs of Demodex blepharitis, including the presence of Demodex mites; presence of collarettes on the lashes, also known as cylindrical dandruff, which are a pathognomonic sign of Demodex blepharitis; and lid margin erythema. Patients were asked questions about ocular symptoms, diagnoses, and history and their questionnaire responses were analyzed. The study found that the functional and psychosocial burdens of Demodex blepharitis are considerable, leading patients to seek treatment and medical care, mostly unsuccessfully:
- More than half of patients (51%) said they had signs and symptoms of blepharitis for at least four years, but most (58%) reported they had never been diagnosed, even though a third had made at least two and sometimes more than six visits to a doctor seeking relief.
- Patients reported their most bothersome symptoms were itchy eyes and dry eyes, with the majority (52%) experiencing these symptoms frequently or all the time in the past month.
- Many patients said they were emotionally affected, with almost half (47%) conscious of their eyes all day, nearly a quarter (23%) constantly worrying about their eyes and 23% saying it gave their eyes or eyelids a negative appearance to others.
- The disease also affected their daily activities, with almost half (47%) reporting difficulty driving at night and nearly a third (30%) saying it added time to their daily hygiene routine.
- Most patients (81%) had sought treatment, but many of these patients discontinue treatment, citing ineffectiveness, tolerability, or other reasons.
“The Atlas study reveals the need for a proven treatment for Demodex blepharitis to treat patients’ disease and end the daily toll it takes on their ocular health and quality of life,” said Bobak Azamian, M.D., Ph.D., President and Chief Executive Officer of Tarsus. “Our goal is to offer patients and eye care professionals the first drug treatment that targets the underlying cause of disease, and may positively impact the significant disease burden. We remain focused on advancing our pivotal TP-03 clinical program and we look forward to initiating Saturn-2 this quarter and announcing the results of Saturn-1 this summer.”
Tarsus also presented the complete findings of the Europa study, a prospective, randomized, vehicle-controlled Phase 2b trial that evaluated the safety and efficacy of twice-daily TP-03, topical lotilaner ophthalmic solution 0.25%, in adult patients with Demodex blepharitis. Enrolled participants received no treatment for blepharitis symptoms (i.e., lid hygiene) during the study, as well as at least 14 days prior.
- In the trial, TP-03 demonstrated statistically significant results for the primary endpoint, collarette cure over vehicle, which was achieved in 80% of patients versus 16%, respectively, at 42 days (p