‘Clinically significant’ collarette resolution, Demodex mite eradication with lotilaner
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SAN DIEGO — Nearly 90% of patients with Demodex blepharitis experienced clinically meaningful cure rates of their collarettes after using lotilaner ophthalmic solution 0.25% twice daily for 43 days, according to a poster presented at Academy 2022.
In addition, mites were eradicated in 52% of study patients’ eyes.
“Demodex blepharitis [DB] is one of the most common conditions we see clinically,” study author Paul M. Karpecki, OD, FAAO, director of cornea and external disease at Kentucky Eye Institute and associate professor at Kentucky College of Optometry at the University of Pikeville, told Healio. “Previous studies such as the Titan study [Trattler et al.] have shown that collarettes, the pathognomonic sign of DB, are present in 58% of all patients seen in an OD or MD practice, including patients wearing contact lenses, with dry eye, glaucoma and cataract evaluations. All of those were represented in the study.”
The researchers conducted the randomized, controlled, double-masked Saturn-2 study, which “was actually the phase 3 pivotal or confirmation study for potential FDA approval, so it’s a significant study,” Karpecki said.
The 412 participants were evaluated at 21 U.S. sites, according to the study. Each participant had more than 10 upper lashes with collarettes, mild or worse lid margin erythema and at least 1.5 mites per lash. They used lotilaner (Tarsus Pharmaceuticals) drops twice daily in each eye for 43 days.
Ninety-six percent of patients experienced at least one grade of improvement in collarettes, and 87% had no more than 0.5 mites per lash by the end of the study. Thirty-one percent experienced complete cure of erythema, according to the study.
“Clinically meaningful cure rates (10 or fewer collarettes per eye) were observed in almost 90% of patients on therapy as opposed to 33% in the placebo group,” Karpecki said. “The drop even had a statistically significant effect on lid erythema compared to placebo, and we see patients with red lid margins from DB quite often and have few options to address it.”
Researchers reported no serious treatment-related adverse events, and 91% of patients rated comfort with lotilaner from neutral to very comfortable.
“At this point there are few effective treatments for DB,” Karpecki said. “So to have a therapeutic agent that can show this level of collarette resolution and mite eradication is significant.”
He said future studies could determine whether eradicating the mite would allow meibum to return to normal, and the relationship between Demodex blepharitis and contact lens intolerance could also be evaluated.
Editor's note: This article was updated Feb. 27, 2023, to clarify a few study details.
Reference:
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Karpecki P, et al. Safety and efficacy of lotilaner ophthalmic solution 0.25% in treating Demodex blepharitis: Results of the phase 3 SATURN -2 trial. Presented at: Academy; Oct. 26-29, 2022; San Diego.
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