The kids are alright: Miebo and Xdemvy at year 1

Man, did that year go fast!

It seems like it was only 2 months ago that Miebo (perfluorohexyloctane ophthalmic solution, Bausch + Lomb) and Xdemvy (lotilaner ophthalmic solution 0.25%, Tarsus Pharmaceuticals) were approved by the FDA and entered the market. It was the second half of 2023, of course, when they made their debut. It is truly amazing how quickly both medications have become fixtures in the daily strategies of literally thousands of eye doctors treating dry eye disease (DED). Not only that, Miebo and Xdemvy, along with Lacrifill (Nordic Pharma), have altered the basics of DED care. No longer do we live in an “either/or” world; the prevailing paradigm is now “and.”

Innovative breakthrough products will do that.

I thought it might be interesting to look at how each of these medications has fared over the course of its first 12 months or so out in the wild. Warning to those of you who never look at the disclosures: I am a consultant and a speaker for both B+L and Tarsus, and I have long been a fan of the people who work for both companies. This is going to be a happy column just dripping with niceness, without apology. After all, it is the holiday season!

From 30,000 feet, both seem to have outperformed their phase 3 registration trials, certainly in our hands. This is rather unusual in general, but it is especially striking given how impressive the study data were for both drugs. Each showed highly significant positive results, and both were well tolerated in phase 3 and long-term safety trials. I have written on this data previously. Across a wide range of DED variants and disease severity, our patients have consistently had positive results with few side effects, and only a handful of a few hundred patients have chosen to discontinue either medication due to side effects. Both Miebo and Xdemvy have recently released new data, and I will touch on that below.

Miebo has been in the works since the mid-2010s. It is designed to reduce evaporation and therefore to reduce the inflammation from desiccation stress. DED doctors have been longing for a drug that directly addresses evaporation itself. The diagnostic clue, as mentioned in my “Back to Basics” series, is a rapid tear breakup time. This drug was anticipated so strongly that, once approved by the FDA, it was up to whatever company that owned the drug not to mess up. Thankfully, in B+L, doctors and patients had a capable partner. As they say on the Marketplace Morning Report, let’s do the numbers.

Miebo was available for only a couple of months at the end of 2023. In that short period of time, sales of Miebo were around $25 million. This year, through the end of the third quarter, Miebo has sold $137.6 million, for a first full year total of $162.6 million. Conservative estimates are for more than $170 million in 2024 sales. Not too shabby! As I am writing this column, there have been 18,000 eye doctors who have prescribed Miebo; most of them have written multiple prescriptions. B+L has done a nice job getting the drug covered by insurance. Roughly 70% of commercially covered patients have coverage, and 50% of government programs (Medicare and Medicaid) do as well. The Miebo launch was named a top 8 drug launch for 2023 by Iqvia. I am betting that you have seen the new TV commercial, part of a direct-to-consumer campaign expected to reach 100 million potential patients.

Oh yeah!

In many ways, Tarsus faced a much heavier lift launching Xdemvy. Whereas B+L was launching a medication into a well-known area of unmet need and a large population anxiously awaiting its arrival, Tarsus had the added burden of raising the awareness of the disease that it was targeting, Demodex blepharitis. The science folks working for Tarsus had to go out and demonstrate that Demodex blepharitis was a significant problem, however sparsely known and poorly understood. And as if those weren’t big enough hurdles, literally nobody not named Hank Perry was doing the traditional diagnostic test to demonstrate the presence of mites, plucking eyelashes and examining them under a microscope.

I mean, yuck! Right?

Before launching Xdemvy, Tarsus ran a classic disease state awareness program that included that most elusive diagnostic test known to man, a pathognomonic sign that signaled the presence of mites with a 95% confidence level. All you do is ask your patient to look down while examining them at the slit lamp. If your patient has collarettes at the base of their eyelashes, those follicles are teeming with mites. Killing those mites reduces inflammation in the meibomian glands and makes patients look and feel better. Again, to the numbers.

In the first 12 months after approval, Tarsus has sold approximately $126 million of Xdemvy at the close of the third quarter of 2024. Approximately 13,000 eye doctors have written an Xdemvy prescription, 70% of whom have written more than one. Like at B+L, the market access folks at Tarsus have been burning the midnight oil to garner access to insurance coverage. As I am writing this, roughly 80% of Americans who have any type of health insurance have coverage for Xdemvy. This can be expensive for a pharmaceutical company because it usually takes massive discounts and rebates to achieve this kind of number. In its third quarter results, Tarsus announced that its average discount is 40%, a low number typically associated with much more established medications. This bodes well going forward for both eye doctors and their patients.

It looks like I got carried away with all the numbers. Let me share a few clinical tidbits the two companies presented at conferences this fall. You can see more details in my recent blog posts. Miebo works fast. I mean really fast. I saw a photo of a poster at the American Academy of Optometry meeting in which B+L shared data on early onset of symptom relief. Miebo brought about meaningful relief to a patient’s self-described most bothersome symptom, to their awareness of their DED and to fluctuation of vision on average in 3 days. That is not a typo. Three. Days. Even better, relief continued to improve when measured on day 7 and day 14.

Not to be outdone, Tarsus did a study looking at the effects of Xdemvy on the signs and symptoms of meibomian gland disease, reported in a poster at the Tear Film & Ocular Surface Society meeting. You know, that thing we treat in which no medicine has ever been shown in a study to make it better. At treatment days 43 and 85, Xdemvy was shown to increase the number of glands producing oil and expressing oil, showing an improvement in more than three glands doing so. Subjects were queried using the visual analog DED scale about visual fluctuation, itching, burning and redness. Once again, there was a significant improvement in all measures at days 43 and 85.

But if you are using Xdemvy and Miebo in your practice, you already know this.

Come January, we can expect it to become easier to prescribe both these medicines for our Medicare patients. Look for even more coverage in your younger patients, too. Remember, these are unique medications with specific indications. There are no equivalent drugs, no alternatives and nothing you need to “step” through before prescribing them. Stick to your guns if you get some crazy prior authorization that says otherwise. Remember, the numbers above are fun and all, but in the end, the only thing that matters is the patient sitting on the other side of your slit lamp.

A Happy Merry from all of us in the White family to you and yours.

• For more information:
• Darrell E. White, MD, of SkyVision Centers in Westlake, Ohio, can be reached at dwhite@healio.com.

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Disclosures:
White reports speaking and consulting for Allergan, Bausch + Lomb, Sun, Tarsus and Viatris, consulting for Aldeyra, Bruder, Nordic Pharma and Thea, and consulting for and being an investor in Orasis.

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