Tarsus completes enrollment in phase 3 Demodex trial, secures $175 million financing
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Tarsus Pharmaceuticals has completed enrollment in the second pivotal phase 3 trial investigating TP-03 for the treatment of Demodex blepharitis and secured a $175 million credit facility, according to a press release.
The randomized, controlled, double-masked Saturn-2 trial is evaluating the efficacy and safety of TP-03 (lotilaner ophthalmic solution 0.25%) in 408 participants with Demodex blepharitis. The primary endpoint is the proportion of patients to experience complete collarette cure, which is being defined as zero to two collarettes per lid.
“We are committed to developing a solution for this disease as rapidly as possible and expect to share topline results from Saturn-2 in April, which, if positive, will be followed by a new drug application for TP-03 planned this year,” Bobak Azamian, MD, PhD, president and CEO of Tarsus, said in the release.
In addition to enrolling Saturn-2, Tarsus has secured a $175 million credit facility.
“We are also grateful to secure this non-dilutive $175 million credit facility, providing Tarsus with significant financial flexibility to drive our business growth as we continue to pioneer the treatment landscape for patients with Demodex blepharitis and other important diseases,” Azamian said in the release.
Perspective
Back to TopDemodex blepharitis is a chronic condition commonly associated with dry eye symptoms. Unfortunately, we do not have FDA-approved therapies specifically indicated for this condition, and many of the available off-label options are irritating and do not ensure the full elimination of Demodex mite populations on human skin. It is wonderful news that soon we may have a new, better option for patients with Demodex blepharitis.
According to recently published studies, treatment with lotilaner ophthalmic solution 0.25% (Tarsus Pharmaceuticals) for 4 to 6 weeks appears to be safe and effective in eliminating the most common objective signs of Demodex blepharitis. Moreover, it is promising that improvement in collarette grade and mite density persisted for at least 2 months following treatment cessation. Demodex blepharitis is a common condition, and I anticipate that having an approved treatment will make an important difference for many of our patients with dry eye. I hope that this treatment will be affordable and easily accessible to those who need it.
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