Xdemvy™ Eye Drop (lotilaner 0.25% ophthalmic solution) approved by FDA July 25, 2023 – Xdemvy™, an anti-parasitic eye drop solution that may be used to treat Demodex blepharitis in adults 18 years of age and older, has been approved by the FDA. Xdemvy is the first and only approved therapeutic for Demodex blepharitis, a highly prevalent eyelid disease that impacts approximately 25 million eye care patients in the U.S.
Demodex blepharitis is a disease caused by an infestation of the eyelashes and eyelash follicles by Demodex mites, the most common ectoparasite found in humans. It is reasonably common, accounting for 45% of blepharitis cases overall, and 84% in people aged 60 and older. Symptoms of Demodex blepharitis include eyelid margin inflammation, redness, and ocular irritation, and it commonly occurs
with rosacea or conditions such as diabetes.
Xdemvy works by inhibiting the gamma-aminobutyric acid (GABA)-gated chloride channels in the Demodex mites to cause paralysis in the mite and its death, and relief of eyelid redness and crusting. Lotilaner does not inhibit GABA-mediated chloride channels in humans at 1100 times the recommended human dose.
The most common side effects of Xdemvy in clinical trials were stinging and burning in 10% of patients. Other side effects in less than 2% of patients were chalazion/hordeolum and punctate keratitis. Xdemvy is expected to be available by prescription by the end of August 2023.
