Xdemvy FDA Approval History
Last updated by Judith Stewart, BPharm on July 25, 2023.
FDA Approved: Yes (First approved July 25, 2023)
Brand name: Xdemvy
Generic name: lotilaner
Dosage form: Ophthalmic Solution
Previous Name: TP-03
Company: Tarsus Pharmaceuticals, Inc.
Treatment for: Demodex Blepharitis
Xdemvy (lotilaner ophthalmic solution) is an isoxazoline ectoparasiticide indicated for the treatment of Demodex blepharitis.
- Demodex blepharitis is a disease caused by overpopulation of Demodex mites in the eyelash follicles. It is characterized by eyelid margin inflammation, redness and ocular irritation.
- Xdemvy is an ectoparasiticide (anti-parasitic) that works by inhibiting the gamma-aminobutyric acid (GABA)-gated chloride channels in the Demodex mites to cause paralysis and death.
- FDA approval was based on the results from two vehicle-controlled studies (Saturn-1 and Saturn-2) that demonstrated statistically significant improvement in patients using Xdemvy at Day 43 compared to those using the vehicle.
- Xdemvy is administered by instilling one drop in each eye twice daily (approximately 12 hours apart) for 6 weeks.
- Common adverse reactions include instillation site stinging and burning.
Development timeline for Xdemvy
Further information
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