Tarsus Pharmaceuticals announces topline results from Ersa Phase 2a trial evaluating lotilaner ophthalmic solution, 0.25%.

(Image Credit: AdobeStock/ดวงหทัย พิทักษ์เจริญ)

Tarsus Pharmaceuticals announced topline results from the Ersa Phase 2a clinical trial evaluating lotilaner ophthalmic solution, 0.25% (TP-03) 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 a press release from Tarsus, the company stated “TP-03 demonstrated statistically significant and clinically meaningful improvements compared to baseline in 2 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 eyelid.”¹

Furthermore, the company stated, “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).”¹

The mean number of meibomian glands secreting clear liquid from baseline was also statistically significant according to the release. Of which, there was 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).¹

Collarette cure and lid margin erythema cure results were consistent with previous TP-03 studies, while no statistically significant differences were observed between the BID and TID treatment arms.

“We are encouraged by these early results, which underscore the potential of TP-03 to address the underlying cause of disease,” said Bobak Azamian, MD, PhD., Chief Executive Officer and Chairman of Tarsus. “We look forward to further analyzing the data from this trial and continued discussions with the US Food and Drug Administration about the best path forward for TP-03 in MGD.”¹

TP-03 (lotilaner ophthalmic solution, 0.25%) was approved by the FDA in 2023 under the brand name Xdemvy for the treatment of Demodex blepharitis and is being evaluated as an investigational therapy for the treatment of Meibomian Gland Disease (MGD) in patients with Demodex mites.

References:

1. 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. Press release. Released December 11, 2023. Accessed December 11, 2023. https://www.globenewswire.com/news-release/2023/12/11/2793790/0/en/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.html