Tarsus Pharmaceuticals, Inc. (NASDAQ: TARS), whose mission is to focus on unmet needs and apply proven science and new technology to revolutionize treatment for patients, starting with eye care, announced that it has enrolled the first patient in a Phase 2a clinical trial studying TP-03 (lotilaner ophthalmic solution, 0.25%) for the treatment of Meibomian Gland Disease (MGD) in patients with Demodex mites. Demodex mites live in the meibomian glands and have been associated with microstructural glandular changes that can result in inflammation. Currently, there are no U.S. Food and Drug Administration (FDA) approved pharmacologic treatments for MGD. TP-03 has been evaluated in two pivotal trials collectively involving more than 800 patients with Demodex blepharitis where it met the primary endpoint and all secondary endpoints and was well-tolerated. Tarsus plans to submit a New Drug Application (NDA) to the FDA for TP-03 for the treatment of Demodex blepharitis in the second half of 2022.
The meibomian glands line the eyelid margin and are responsible for secreting lipids that make up the superficial lipid layer of the tear film and prevent tears from evaporating. MGD occurs when the glands are not producing enough lipids, or the lipids they secrete are of poor quality. MGD is highly prevalent and thought to be the leading cause of Dry Eye Disease, impacting approximately 2/3 of the 34 million patients with Dry Eye Disease in the U.S. Patients with MGD experience symptoms of eye irritation and inflammation and when left untreated, may experience permanent changes to the tear film and progressive gland loss.
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