FDA Approves Novel Demodex Blepharitis Treatment

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Tarsus Pharmaceuticals’ Xdemvy (lotilaner ophthalmic solutions) is designed to treat Demodex blepharitis by directly targeting Demodex mites.

Tarsus Pharmaceuticals, a biopharmaceutical company developing treatments in the fields of eye care, dermatology, and infectious disease prevention, announced FDA approval of Xdemvy (lotilaner ophthalmic solutions) 0.25% for the treatment of Demodex blepharitis on July 25, 2023. According to a company press release, Tarsus’ lotilaner ophthalmic solution is the first and only FDA approved treatment that directly targets Demodex mites, the root cause of Demodex blepharitis.

According to the release, Demodex blepharitis is a common lid margin disease that is characterized by eyelid margin inflammation, redness, and ocular irritation. The disease impacts approximately 25 million adults in the United States. Lotilaner ophthalmic solution treats the condition by selectively inhibiting the Demodex mites’ gamma-aminobutyric acid-gated chlorine (GABA-Cl) channels. Lotilaner ophthalmic solution was evaluated in two pivotal trials of more than 800 patients that the met primary endpoint and all secondary endpoints, with statistical significance and no serious treatment-related adverse events.

“We are thrilled to announce the FDA approval of Xdemvy [lotilaner ophthalmic solution] for the treatment of Demodex blepharitis and look forward to making this product broadly available to the millions of patients who have not had any FDA approved therapeutics for this disease,” said Bobak Azamian, CEO and chairman, Tarsus, in the release. “This tremendous milestone was achieved through a successful collaboration of our talented Tarsus team, countless eye care providers, and the hundreds of patients who participated in our trials. We are grateful and honored for the opportunity to introduce the first and only approved therapeutic for this disease to the eye care community.”


“After years of seeing Demodex blepharitis in my practice without an effective way to target the root cause of the disease, I’m so pleased to have a new treatment to offer my patients,” said Christopher Starr, associate professor of Ophthalmology, director of Refractive Surgery, Ophthalmic Education and the Cornea Fellowship Program, Weill Cornell Medicine, New York Presbyterian Hospital, in the release. “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. This new medicine is a positive step forward for the treatment of this disease in many patients who have been struggling for years.”

Source: Tarsus Pharmaceuticals