FDA approves Xdemvy for Demodex blepharitis treatment
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Key takeaways:
- The FDA approved Xdemvy to treat Demodex blepharitis.
- The lotilaner ophthalmic solution is expected to be available by the end of August.
The FDA approved Xdemvy, a 0.25% lotilaner ophthalmic solution, for the treatment of Demodex blepharitis, according to a press release from Tarsus Pharmaceuticals.
“The approval of Xdemvy represents a new solution that eye care providers will have in their toolbox to manage patients with Demodex blepharitis,” Aziz Mottiwala, chief commercial officer at Tarsus, told Healio. “Xdemvy significantly improves eyelids in terms of collarette reduction, cures erythema and eradicates mites — the primary cause of the disease.”
Xdemvy, formerly known as TP-03, is the first FDA-approved treatment targeting Demodex mites.
The approval is based on the Saturn-1 and Saturn-2 studies; 833 patients were included in the studies, with 415 receiving Xdemvy. By day 43 in each study, patients experienced a significant improvement in the eyelids, with a reduction to no more than two collarettes per upper lid. Additional significant improvements were observed in mite eradication and erythema cure endpoints at day 43.
The treatment was safe and well tolerated. The most common ocular adverse reactions were instillation site stinging and burning, reported in 10% of patients.
Tarsus expects Xdemvy to be available by prescription by the end of August.
“This approval provides an opportunity to treat the already diagnosed 1.5 million Demodex blepharitis patients who are actively seeking treatment, as well as millions of other cataract patients, those with contact lens intolerance or those suffering with dry eye disease (all who also present with Demodex),” Mottiwala told Healio. “With this approval, we are building a new category in eyelid health — this represents a significant step forward in eye care.”
Editor’s note: This article was updated on July 25, 2023, to include comments from Aziz Mottiwala, and on July 26, 2023, to include a perspective from Selina R. McGee, OD, FAAO."
Perspective
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More than half of my patients have clinically meaningful Demodex blepharitis, and the consequences of this disease are significant — patients struggle with wearing contact lenses comfortably and they have chronic itchy, red eyes and recurrent issues with hordeola and chalazia. For some of my patients preparing for cataract surgery that require optimized ocular health for better outcomes, management and treatment of this disease have been limited. Despite the large number of patients with Demodex in my practice, I’ve struggled with offering solutions that work — namely because we’ve not had anything that actually treats the root cause of the disease.
This approval is important because it presents a new, effective solution to a large unmet market need, and I’m thrilled that my patients will finally have an easy twice-daily drop for 6 weeks that results in improvements in lids (reduction in collarettes), eradication of mites and erythema cure. I already have a list of patients who have been awaiting for this therapeutic, and they will be thrilled to know that it is now available.
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