Tarsus Pharmaceuticals, Inc., whose mission is to focus on unmet needs and apply proven science and new technology to revolutionize treatment for patients, has recently 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 < 0.001). The improvement in the mean number of meibomian glands secreting clear liquid from baseline was also statistically significant and clinically meaningful, with an increase of 4.8 (±0.8 SE) and 5.3 (±1.1 SE) glands for the BID and TID arms, respectively, at Day 85 (p < 0.001). Collarette cure and lid margin erythema cure results were also statistically significant and consistent with the results of previous TP-03 studies. No statistically significant differences were observed between the BID and TID treatment arms and TP-03 was well tolerated.
“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.”
Read the full press release from Tarsus.
Source: Tarsus Pharmaceuticals