Tarsus Pharmaceuticals, Inc. 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, MD, PhD, CEO 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 TP-03
TP-03 (lotilaner ophthalmic solution, 0.25%) is a novel therapeutic designed to treat Demodex blepharitis by targeting and eradicating the root cause of disease – Demodex mite infestation. It 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. Lotilaner is a well-characterized anti-parasitic agent that paralyzes and eradicates Demodex mites by selectively inhibiting parasite-specific gamma-aminobutyric acid-gated chloride (GABA-Cl) channels. It is a highly lipophilic molecule, which may promote its uptake in the oily sebum of the eye lash follicles where the mites reside.