Tarsus just announced the approval of the first topical therapeutic to treat Demodex blepharitis, called Xdemvy. Photo: Tarsus. Click image to enlarge.

Despite being one of the more common ocular conditions seen by eyecare professionals, Demodex blepharitis has for decades lacked interventions beyond encouraging better lid hygiene to reduce bacterial overgrowth and recommending eyelid cleansers with tea tree oil to help eradicate mites. Now, after much anticipation, the first targeted therapeutic for Demodex blepharitis has finally received FDA approval. Called Xdemvy (lotilaner ophthalmic solution 0.25%, Tarsus), the drug is to be used twice daily for six weeks and demonstrates an ability to reduce collarettes in as few as 15 days, the company reports.

The safety and efficacy of the new drug were evaluated through two Phase III trials (Saturn-1 and Saturn-2) in which 833 patients received either Xdemvy or vehicle. Patients on Xdemvy achieved significant improvement in eyelids by day 43, marked by a reduction of collarettes to no more than two per upper lid. The endpoints of mite eradication (zero per lash) and erythema cure (grade zero) also showed significant improvement at day 43 in both trials:

• In Saturn-1, 81% of subjects receiving treatment had a collarette grade of zero or one on day 43 vs. 23% for placebo. In Saturn-2, these percentages were 89% vs. 33%, respectively.
• By day 15, 68% of patients in Saturn-1 achieved complete mite eradication vs. 18% of those on placebo.

The company reports that instillation site stinging and burning was the most common adverse reaction, affecting 10% of patients who received Xdemvy. Less than 2% experienced more severe adverse reactions, which included chalazion/hordeolum and punctate keratitis.

Xdemvy is expected to be available by the end of next month, Tarsus says.

For more information, go to www.xdemvy.com.