BLOG: TP-03 is now Xdemvy — Tarsus medication gets FDA approval
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Key takeaways:
- The FDA approved Xdemvy to treat Demodex blepharitis.
- Tarsus has prepared for the approval of Xdemvy with a disease state awareness campaign.
Two down, one to go.
I’ve been telling you that there were three potentially transformative dry eye disease (DED) medications in the FDA queue waiting for approval. In May, Bausch + Lomb got an early gift with a thumbs-up for Miebo, the first approved treatment for DED associated with meibomian gland dysfunction (MGD). At the end of July, Tarsus gave us No. 2 on the hit parade with the approval of Xdemvy to treat Demodex blepharitis. Which leaves only Aldeyra waiting on the sideline with a November PDUFA date for reproxalap (and consigning us all to another September anti-inflammatory column talking primarily about steroids, cyclosporine and lifitegrast).
First, let me congratulate Tarsus for getting such a fortuitous name for its medication and thank everyone involved for choosing one that’s easy to pronounce. Ex-DEM-vee. Easy-peasy. No Brett Favre-ver-rer-style jokes for this little gem. It’s pretty catchy, don’t you think? Makes sense, too. It has DEM in there, just enough of Demodex to let you know what the point is. And speaking of the point, how about that little “ex” up front. Right? This stuff creates lots and lots of former mites. Nailed it, just like Miebo.
No pressure up there in Massachusetts when y’all are up to bat choosing a name for reproxalap.
I’ve noted previously that the folks at Tarsus have done a great job at setting the table for Xdemvy with perhaps the best preapproval disease state awareness campaign in our space. Nobody except Hank Perry plucks out eyelashes and looks for Demodex goobers under a microscope, but thanks to Arthur Chan and his experts on wiggly things, we now know that cylindrical dandruff on eyelashes, collarettes, are pathognomonic for Demodex. Look down! A quick glance at the lid margin after instructing your patient to look down makes the diagnosis. Sixty-nine percent of blepharitis cases are at least in part due to Demodex infestation.
Xdemvy is neurotoxic to the Demodex mite. Two pivotal FDA trials were performed in which a total of 833 subjects were treated with Xdemvy twice daily for 6 weeks. Mite eradication and reduced lid erythema were seen as early as 14 days in. The effect was long-lasting; more than 60% of those treated maintained a clinically meaningful reduction of collarettes from grade 3 (more than two-thirds lid involvement) to grade 1 (fewer than 10 total collarettes) without additional maintenance therapy. The drug is well tolerated, with around 90% of those treated describing it as neutral or comfortable without blurring vision.
For more than a year, we have been actively and aggressively looking for evidence of Demodex infestation in our blepharitis/MGD patients, racking up literally hundreds of folks who will benefit from Xdemvy. As I write this, I have no idea what Tarsus’ plans are regarding sampling (gotta do it!), pricing (meh, nobody pays list price) and true cost/access for patients (everybody is watching). There’s a big opportunity here. Thankfully, there are a bunch of really savvy execs manning the helm of the S.S. Tarsus; there’s a fighting chance we’ll be able to get this stuff to our patients.
Think about it for a moment. MGD/blepharitis-associated evaporative DED care is about to undergo a sea change. Diagnose symptomatic evaporative DED, with or without other necessary (read: inflammation-reducing) meds? Miebo for the symptoms, and either Xdemvy if you see collarettes or AzaSite (azithromycin ophthalmic solution, Théa) if you don’t, with thermal/evacuation and light-based treatments like intense pulsed light to turbocharge the improvement.
Can’t wait!
References:
- Gao YY, et al. Invest Ophthalmol Vis Sci. 2005;doi:10.1167/iovs.05-0275.
- Trattler W, et al. Clin Ophthalmol. 2022;doi:10.2147/OPTH.S354692.
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