BLOG: Xdemvy and meibomian gland disease: We might have a winner
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Key takeaways:
- Tarsus presented data showing Xdemvy improved gland function and symptom scores.
- Xdemvy may be used as a single agent in the setting of evaporative dry eye with poor gland function and Demodex infestation.
It seems as if eye doctors who treat the ocular surface and eyelids have been looking for a safe and effective treatment for the signs and symptoms of meibomian gland disease forever.
Has there ever been a treatment that successfully passed muster with the FDA and became approved to treat meibomian gland disease (MGD) on label? Only TobraDex (tobramycin/dexamethasone ophthalmic suspension, Harrow) and later iterations come to mind, and honestly, I can’t remember if Alcon was able to pull that off. My beloved AzaSite (azithromycin ophthalmic solution 1%, Thea) was never even given a chance. If memory serves, my visit to Inspire headquarters pre-2010 sparked interest, but Inspire didn’t survive long enough to take a chance on a study.
So, you can imagine how exciting it is to have seen the data that Tarsus presented at the American Academy of Optometry meeting this fall in Indy. The Ersa study evaluated the safety and efficacy of Xdemvy (lotilaner ophthalmic solution 0.25%) in the treatment of MGD, with RHEA for the vehicle, in patients who are diagnosed with both MGD and grade 2 or higher Demodex. Fifteen central glands were assessed in each patient at baseline and days 43 and 85. Glands were evaluated for overall score, number of glands excreting oil and percent of glands improved to clear oil. Patient symptoms were evaluated using visual analog scale (VAS) scoring. Both Xdemvy and its vehicle were very well tolerated with only two adverse events in the Xdemvy cohort, both of which were mild. No subjects discontinued the trial due to medication-related reasons.
The results are stunning!
Statistically significant positive changes were seen in the Xdemvy trial in all areas tested. Glands were scored as 0: no excretion; 1: thick, opaque; 2: cloudy; or 3: clear (higher score equals better function). Scores improved from 21.9 at baseline to 27.8 at day 43 and 33.2 at day 85, all statistically significant. Glands yielding oil went from 7.1 to 10.7 at day 43 and 12.7 out of 15 at day 85. Subjects with more than three glands improving to “clear” were 44.7% at day 43 and 78.9% at day 85. Xdemvy improved objective measurements of meibomian gland function across the board.
How about symptoms? Patients care about how they feel and how they look. Pretty much the same story across the board. VAS scores symptoms from 0 (none) to 100 (it’s all you can think about) were measured at baseline, day 43 and day 85. Fluctuating vision decreased from 46.5 to 22.2 to 13.1, overall a 72% decrease. Burning went from 35.4 to 20 to 10.5, a 70% change. The same thing was seen with itching (47 to 16 to 11.4, 75%) and eyelid redness (43.6 to 16.6 to 12.2, 72%). Bottom line: Xdemvy appears to be a safe and effective treatment for the signs and symptoms of MGD in the presence of Demodex.
What does this mean in our dry eye disease (DED) clinics? I think this data give us a clear path to consider Xdemvy when we make a diagnosis of evaporative DED (poor tear function) along with poor gland function and Demodex infestation. Depending on your core treatment philosophy, you could certainly use Xdemvy as a single agent in this setting. I find myself using Xdemvy to go after the underlying cause of the DED while simultaneously treating the tears themselves with a second agent. This is all super new; time will tell if one strategy is better than the other.
But after decades of trying, it sure looks like we finally have a winner to treat MGD.
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