First Treatment for Demodex Blepharitis Wins FDA Approval

The FDA approved lotilaner ophthalmic solution 0.25% (Xdemvy) as the first specific treatment for Demodex blepharitis.

Lotilaner (formerly TP-03) is an ectoparasiticide that targets Demodex mites, which invade and reside in hair follicles of the eyelashes and subsequently cause eyelid inflammation.

Demodex blepharitis affects an estimated 25 million people in the U.S. Often misdiagnosed or underdiagnosed, the condition produces symptoms that include redness, inflammation, missing or misdirected eyelashes, horizontal itching along the eyelid base, and the presence of collarettes — a cylindrical waxy debris of mite waste and eggs — found at the base of eyelashes.

“Demodex blepharitis, easily diagnosed by the presence of eyelash collarettes, can result in ocular damage in multiple ways, including irritation, eyelash distention or loss, and inflammation, which can be uncomfortable for patients,” said Christopher Starr, MD, of Weill Cornell Medicine and NewYork-Presbyterian Hospital in New York City, in a statement from developer Tarsus Pharmaceuticals. “This new medicine is a positive step forward for the treatment of this disease in many patients who have been struggling for years.”

Support for the approval came from two randomized, vehicle-controlled studies (Saturn-01 and Saturn-02) involving a total of 833 patients. Both trials met the primary endpoint of reducing collarettes to no more than two per upper eyelid by day 43. Both trials also met the additional endpoints of mite eradication and erythema cure, as lotilaner achieved statistically higher rates versus vehicle by day 43.

In the pivotal Saturn-02 trial, for example, 56% of patients randomized to lotilaner achieved collarette cure at this time point versus 13% of patients in the vehicle group (P<0.0001). Mite eradication rates were 52% versus 15%, respectively, while erythema cure rates reached 31% with the active agent as compared to 9% with vehicle. The phase III trial enrolled over 400 patients across 21 U.S. sites.

Treatment with lotilaner involves one drop of the solution in each eye, given twice daily (roughly 12 hours apart) over a 6-week course.

According to the prescribing information, the most common adverse events associated with lotilaner were stinging and burning at the instillation site, occurring in 10% of patients. Other ocular adverse events included chalazion/hordeolum (sty) and punctate keratitis, affecting fewer than 2% of patients.

Tarsus said the drug would be available for prescribing by the end of August.

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