The New Therapeutic Option Targets Root Cause of the Condition
Xdemvy™, a lotilaner ophthalmic solution, has received FDA approval for treating Demodex blepharitis. The approval is backed by robust clinical data, offering a new avenue for clinicians to manage this condition effectively.
- Xdemvy contains lotilaner, a GABA-gated chloride channel inhibitor selective for mites.
- Approval based on two 6-week randomized studies (Saturn-1 and Saturn-2) involving 833 patients.
- In Saturn-1, 44% of Xdemvy-treated patients achieved the primary endpoint of cure based on collarette score, compared to 7% in the control group (P <.01).
- In Saturn-2, 55% of Xdemvy-treated patients achieved the primary endpoint, compared to 12% in the control group (P <.01).
- Secondary endpoints included mite eradication and erythema cure, with significant improvements noted in the Xdemvy group.
- Most common adverse reaction was instillation site stinging and burning; less than 2% reported chalazion/hordeolum and punctate keratitis.
- Xdemvy offers a targeted and effective treatment for Demodex blepharitis, with strong clinical data supporting its efficacy and safety profile.
“We are thrilled to announce the FDA approval of Xdemvy 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.”
– Bobak Azamian, MD, PhD, Chief Executive Officer and Chairman of Tarsus