Tarsus Pharmaceuticals Inc’s (NASDAQ: TARS) treatment, TP-03, has met primary and secondary endpoints in the company’s Phase III study. The company also found that the drug was safe. These results would enable Tarsus to treat Demodex blepharitis. This disease affects the eyelid.
Since it has gotten positive results from the trial, Tarsus intends to seek New Drug Application approval from the FDA.
The study built on data from Saturn-1
According to Tarsus’ CEO and President, Dr Bobak Azamian, the company embarked on the Saturn-2 study after receiving positive results from the Saturn-1 study. The second study added to the first study. Through it, the company has confirmed the drug’s safety and efficacy in patients with the disease.
Dr Azamian adds that the company’s findings are a milestone. They could help the company treat people with Demodex blepharitis globally. The company is now focused on getting an NDA for TP-03. This move would allow Tarsus to serve patients and eye specialists and eventually resolve the disease.
Dr Bobak expresses his gratefulness to the researchers and patients in the study who stayed focused despite the challenges that COVID-19 brought. Their sacrifice would enable the company to move forward ins seeking regulatory approval and treating 25 million Americans in the U.S alone with the disease.
Tarsus’ CMO and Director, Dr Elizabeth Yeu, states that the Saturn 2 and 1 trials proved that TP-03 could safely and perfectly treat Demodex blepharitis. Patients with this disease often suffer from no relief as there is no safe and effective treatment. Fortunately, this new therapy could change that. Patients with this disease also struggle with their eyesight.
How the company conducted the study
Saturn-2 was a double-masked, controlled, randomised trial. The researchers gathered 412 adult patients with the disease. Each volunteer had over ten collarettes on each lid. They also had mild redness on their lids.
The team required the patients to use a drop of the drug twice daily. This study took six weeks. Furthermore, the patients didn’t get other treatments for the disease such as eyelid hygiene during the study or two weeks before it began. The team found the drug to be effective and safe in treating these patients.