Lotilaner ophthalmic solution 0.25% (Xdemvy) was approved by the FDA in July, making it the first and only approved treatment for Demodex blepharitis.
Tarsus Pharmaceuticals announced that lotilaner ophthalmic solution (Xdemvy) 0.25% is now ready for prescription as it is available at pharmacies nationwide. The eye drop Xdemvy received FDA approval on July 24, 2023, making it the first and only approved treatment for Demodex blepharitis.
“We are delighted that within weeks of FDA approval, XDEMVY is now available to millions of patients with Demodex blepharitis,” Bobak Azamian, MD, PhD, Chief Executive Officer and Chairman of Tarsus, said in a press release. “The efforts of our team have created incredible interest in XDEMVY, the first and only approved solution for this highly prevalent disease. I’m so appreciative of our team and our partners who’ve worked diligently to bring this product to eye care providers and patients quickly and seamlessly following regulatory approval. We are proud to introduce XDEMVY to the eye care community and look forward to its potential to significantly change the way this disease is treated.”
Xdemvy is an eye drop indicated to target Demodex mites, which cause Demodex blepharitis. When prescribed, patients will administer one drop per eye, twice a day (approximately 12 hours apart), for 6 weeks to address redness, inflammation, missing or misdirected eyelashes, itching along the eyelid base, and the presence of collarettes that characterize Demodex blepharitis. Xdemvy contains potassium sorbate, so patients should remove soft contact lenses prior to application to avoid discoloring the lenses. Lenses can be reinserted 15 minutes after the drops are administered.
Demodex blepharitis is prevalent in eye care clinics across the country, with approximately 25 million eye care patients in the US afflicted every year. The lid margin disease is caused by an infestation of Demodex mites, and Xdemvy is the first and only drop on the market to target the mites directly to reduce collarettes and mitigate symptoms. The active ingredient, lotilaner, eradicates mites by selectively inhibiting GABA-Cl channels. Tarsus made use of the highly lipophilic molecule, which promotes updake in the oily sebum of the eyelash follicles where the mites are found.
Xdemvy was investigated in 2 pivotal clinical trials, Saturn-1 and Saturn-2. Both trials evaluated lotilaner ophthalmic solution in over 800 participants, and each trial met both primary and secondary endpoints with no serious adverse events reported. Most commonly, participants reported stinging and burning, which occurred in about 10% of the sampled population. Other ocular adverse events included chalazion/hordeolum (stye) and punctate keratitis—each were reported by less than 2% of patients.
For more information on Xdemvy and Tarsus, please visit the website.