Tarsus Announces Positive Topline Data from Saturn-2 Phase 3 Trial of TP-03 for the Treatment of Demodex Blepharitis
Tarsus Pharmaceuticals announced that TP-03 (lotilaner ophthalmic solution, 0.25%) met the primary endpoint and all secondary endpoints in the Saturn-2 pivotal phase 3 trial with a favorable safety profile, reinforcing its ability to resolve Demodex blepharitis. With these positive results, Tarsus plans to submit a new drug application (NDA) to the FDA in the second half of 2022.
“The positive Saturn-2 data builds on the compelling results we observed in Saturn-1, demonstrating clear consistency in the safety, efficacy and strong clinical value proposition of TP-03. This milestone enables a first potential treatment for Demodex blepharitis and most importantly, provides hope to the millions of patients suffering from this disease,” Bobak Azamian, MD, PhD, President and Chief Executive Officer of Tarsus, said in a company news release. “As we direct our focus toward NDA filing and commercialization, we are one step closer to providing a solution to eye care professionals and patients that can resolve this disease. We are truly grateful to the many patients who participated in the trial and appreciate their time and commitment despite the challenges presented by the ongoing COVID-19 pandemic. We are also sincerely thankful for the investigators and our clinical team who skillfully drove the execution of this successful trial. We’re thrilled to move the regulatory path forward for TP-03, which—if approved by the FDA—will potentially establish a definitive standard of care for Demodex blepharitis and benefit as many as 25 million U.S. patients in need.”
“The high statistical significance and clinically meaningful outcomes in Saturn-2 and Saturn-1 demonstrate the impressive ability of TP-03 to resolve Demodex blepharitis, a disease that has long been without an effective, safe treatment option,” Elizabeth Yeu, MD, Director and Chief Medical Advisor for Tarsus, said in the news release. “We know that this disease has a significant impact on patients’ vision and their daily life, and that they often struggle for years without relief. I am thrilled at the prospect of having TP-03 potentially available in the near future.”
Saturn-2 Topline Results
Saturn-2 is a phase 3 randomized, controlled, double-masked trial evaluating the efficacy and safety of TP-03 in patients with Demodex blepharitis. The trial enrolled 412 adults having more than 10 collarettes per lid and at least mild lid erythema (redness). Each patient also had at least 1.5 mites per lash. One drop of TP-03 was self-administered twice per day in each eye for six weeks. Enrolled patients received no treatment for blepharitis (e.g., lid hygiene) during the trial or 14 days prior to enrollment. Key topline results:
- Primary endpoint: Complete collarette cure, defined as 0 to 2 collarettes per lid at day 43, was achieved by 56% of patients on TP-03, compared to 13% on vehicle (p<0.0001).
- Additionally, 89% of patients achieved a significant, clinically meaningful collarette cure defined by a collarette grade of zero (0) or one (1) at day 43 compared to 33% of those on vehicle (p<0.0001).
- Secondary endpoints:
- Mite eradication: Defined as a mite density of zero (0) mites per lash, was achieved by 52% of patients on TP-03 compared to 14% on vehicle (p<0.0001) at day 43.
- Complete lid erythema (redness) cure: 31.1% of patients on TP-03 compared to 9.0% of patients on vehicle (p<0.0001) achieved a complete lid erythema cure at day 43.
- Complete composite cure: 19.2% of patients on TP-03 achieved a complete composite cure, based on achieving both collarette cure and erythema cure, compared to 4.0% on vehicle (p<0.0001) at day 43.
- Safety Profile: Consistent with Saturn-1, Saturn-2 trial results demonstrated that TP-03 was well-tolerated with a safety profile similar to the vehicle group.
- 91% of patients reported that the drop comfort was neutral to very comfortable.
- There were no serious treatment-related adverse events. The only adverse events occurring at a rate of ≥1% in the TP-03 group were instillation site pain/burning/stinging (7.9%, n=16) and dry eye (1.5%, n=3).