Tarsus Pharmaceuticals announced data from its Demodex blepharitis clinical program presented at the virtual Association for Research in Vision and Ophthalmology (ARVO) 2021 Annual Meeting. Tarsusâ€™ 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, according to Tarsus. The Atlas study is the first multicenter 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.
â€śThe 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,â€ť Elizabeth Yeu, MD, Chief Medical Advisor for Tarsus, said in a company news release. â€śThe 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.â€ť
The Atlas study surveyed 311 patients who were pre-screened at 8 sites participating in Tarsusâ€™ 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.Â 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 4 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.
â€śThe Atlas study reveals the need for a proven treatment for Demodex blepharitis to treat patientsâ€™ disease and end the daily toll it takes on their ocular health and quality of life,â€ť Bobak Azamian, MD, PhD, President and Chief Executive Officer of Tarsus, said in the news release. â€śOur 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.â€ť
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<0.001).
- Furthermore, TP-03 demonstrated statistically significant results for the secondary endpoints. Mites were eradicated in 73% of patients treated with TP-03 compared to 21% of the vehicle group (P=0.003) and composite collarette and erythema cure was achieved in 73% of patients treated with TP-03 compared to 11% of the vehicle group, both at 42 days (P<0.001).
- In post hoc analyses, 93% of patients treated with TP-03 had a clinically meaningful outcome of 10 or fewer lashes with collarettes by day 42.
- Additional post-hoc analyses showed that 87% of patients treated with TP-03 had mite density reduced by 50% or more by day 14.
- There were no serious adverse events and no discontinuations due to adverse events.
The positive results observed in the Europa study were used as the basis for the pivotal phase 2b/3 Saturn-1 and phase 3 Saturn-2 trials of TP-03 to treat Demodex blepharitis.