On 25th July 2023, the biopharmaceutical company Tarsus Pharmaceuticals shared that their anti-parasitic eye drop Xdemvy (lotilaner ophthalmic 0.25%) has been approved by the US Food and Drugs Association (FDA).
Demodex blepharitis is the most common of blepharitis, which is a type of ocular inflammation that affects the eyelid margin. This type of blepharitis is caused by Demodex infestation and leads to symptoms like burning, itching, and more.
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Previously, due to no FDA-approved treatment available, this blepharitis had been termed a non-treatable and chronic inflammation and was treated with makeshift remedies. However, this changes with the FDA approval of Xdemvy which comes after the impressive results Xdemvy provided in the clinical trials. This eye-drop solution can kill and eradicate the Demodex mites from the eyelids.
With its impressive results and FDA approval, Xdemvy has become the first and only FDA-approved treatment for Demodex Blepharitis and will allow countless patients to finally be relieved.
Bobak Azamian, CEO and Chairman of Tarus shared an official statement regarding the same - “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”.
Xdemvy will now be available to the patients of Demodex blepharitis through prescription in the United States from August onwards. This eye drop can be administered in the recommended dosage of 1 drop for each eye, twice a day for six weeks.
“This new medicine is a positive step forward for the treatment of this disease in many patients who have been struggling for years.” - Christopher Starr, associate professor of Ophthalmology, director of Refractive Surgery, Ophthalmic Education and the Cornea Fellowship Program, Weill Cornell Medicine, New York Presbyterian Hospital
As the first and only FDA-approved treatment option for Demodex blepharitis, Xdemvy is guaranteed to bring relief to millions of people who suffer from this inflammation. However, it will also be interesting to see how it affects the bacterial eye therapeutics market as well.