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Tarsus Announces Positive Topline Results from the Ersa Phase 2a Clinical Trial Evaluating TP-03 for the Treatment of Meibomian Gland Disease in Patients with Demodex Mites
TP-03 demonstrated statistically significant and clinically meaningful improvements across two objective measures of MGD, regardless of BID or TID dosing, and
About this update from Tarsus Pharmaceuticals, Inc.
[{"type":"text","content":"TP-03 demonstrated statistically significant and clinically meaningful improvements across two objective measures of MGD, regardless of BID or TID dosing, and was well tolerated\nIRVINE, Calif., Dec. 11, 2023 (GLOBE NEWSWIRE) -- 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, today announced topline results from the Ersa Phase 2a clinical trial evaluating TP-03 (lotilaner ophthalmic solution, 0.25%) administered twice daily (BID) or three times a day (TID) for 12 weeks for the treatment of Meibomian Gland Disease (MGD) in patients with Demodex mites. In this study, TP-03 demonstrated statistically significant and clinically meaningful improvements compared to baseline in two objective measures of the disease – the presence and quality of liquid secretion as measured by the Meibomian Gland Secretion Score (MGSS, scoring range of 0-45), and the number of glands secreting normal (clear) liquid as measured in the central 15 glands of the lower eyelid1-4. Specifically, a significant and clinically meaningful increase from baseline was observed in the mean MGSS of 10.5 (±1.6 standard error, SE) and 11.7 (±1.9 SE) for the BID and TID arms, respectively, at Day 85 (p “We are encouraged by these early results, which underscore the potential of TP-03 to address the underlying cause of disease,” said Bobak Azamian, M.D., Ph.D., Chief Executive Officer and Chairman of Tarsus. “We look forward to further analyzing the data from this trial and continued discussions with the U.S. Food and Drug Administration about the best path forward for TP-03 in MGD.” About Meibomian Gland DiseaseMeibomian Gland Disease (MGD) patients with Demodex mites often present with inflammation of the eyelid margin and blurred vision, which occurs when the meibomian glands are damaged and can result in blockage and/or decreased production of meibum liquid. If left untreated, MGD can lead to permanent changes to the tear film and progressive gland loss. Approximately 30-40 million Americans5,6 have been diagnosed with MGD. Currently, there are no pharmacologic U.S. Food and Drug Administration (FDA) approved therapies for MGD. About TP-03 TP-03 (lotilaner ophthalmic solution, 0.25%) is a novel therapeutic designed to treat Demodex blepharitis by t...