Tarsus Pharmaceuticals, Inc. announced that XDEMVY (lotilaner ophthalmic solution) 0.25%, indicated for the treatment of Demodex blepharitis, is now commercially available in the United States.
Give me a little recap on this drug.
Developed under the name TP-03, XDEMVY (pronounced X-DEM-VEE) is a topical ophthalmic formulation of lotilaner 0.25% that targets and removes Demodex mite infestation—the root cause of Demodex blepharitis.
As the solution’s active ingredient, lotilaner works as an antiparasitic agent to target parasite-specific GABA-CI channels (located within the nervous system channels) to eliminate Demodex mites.
When was it approved?
A month ago, on July 25, 2023.
Click here to watch Tarsus CEO Bobby Azamian discuss the approval with Glance President Jaclyn Garlich, OD, FAAO.
And the recommended dosage?
Per its prescribing information, it is recommended to instill one drop of XDEMVY 0.25% (2.5 mg/mL) in each eye twice daily (approximately 12 hours apart) for 6 weeks.
See here for the full details.
What’s the clinical data on it?
Data from the SATURN-1 and SATURN-2 clinical trials reported XDEMVY to have a favorable safety profile and was well-tolerated.
Further, 50% of patients exhibited a reduction of collarettes and 60% of patients exhibited no Demodex mites following treatment.
See here for the rundown on the SATURN-1 and SATURN-2 clinical trial data.
So where can I find it?
According to Tarsus, four pharmacies across the country have been activated to work with eye care practitioners’ (ECPs’) offices:
- AllianceRx Walgreens
- BlinkRx
- Carepoint
- CVS Specialty
Click here for details on potential prescription savings.
Significance?
XDEMVY is currently the first and only FDA-approved treatment for targeting and potentially eliminating Demodex mites in managing patients with Demodex blepharitis.