Mitchell Shultz, MD, of Shultz Chang Vision, spoke with Ophthalmology 360 at the American Society of Cataract and Refractive Surgery Annual Meeting
Mitchell Shultz, MD:
I’m happy to be speaking to you here from ASCRS 2025 in Los Angeles. Just as a formality, I am a consultant for Tarsus as well as one of the investigators on their clinical trials.
Today, I’m going to talk to you just briefly a little bit about the ERSA and the RHEA studies, which we did. We were a pilot study, that was looking at the effects of lotilaner 0.25% solution in the treatment not just of Demodex blepharitis, but the effects on the meibomian gland function of our patients who have concurrent Demodex blepharitis.
When we look at the study, the patients had to have several criteria to be included in the study. Number 1, they had to have some meibomian gland dysfunction with a functional score of 12 to 15 glands that were functioning. They had to have at least 33% of their glands functioning during the study, as well as having Demodex blepharitis with collarette scoring of at least 10 collarettes on one eyelid to be included in the study. They had to have some form of complaint on the vision assessment scale, demonstrating the fact that they were subjectively affected by their quality of vision, which we believe was associated with their blepharitis associated with Demodex and meibomian gland dysfunction.
When we look at the data, this was a little bit different than what you may be accustomed to with the Saturn-1 and -2 studies. In Saturn-1 and -2 studies, we only treated patients for 43 days and patients were only BID dosed. One study, the ERSA study, where we actually just looked at the lotilaner solution effectiveness at BID versus TID dosing, but rather than 43 days, we actually treated patients for 85 days. In the RHEA study, we actually just looked at the vehicle control. None of the patients in the RHEA study actually got active medication treatment. They were just looked at BID versus TID dosing of the vehicle.
What was interesting in the study was to see what the function was on meibomian glands. Clearly, we saw a separation between the vehicle and the active medication. What was interesting, whereas in the Saturn studies where we only looked at 43 days, by treating for 85 days, we actually did see a continuous benefit for the treatment of Demodex blepharitis as well as improvement in meibomian and gland function. At the end of the 85 days, when we looked at patients, 43 days, about 45% of patients got to what we would call clinical resolution or less than two collarettes present on the eyelids. In these studies, we actually saw about 66% of patients achieving a zero to 2 collarette score at 85 days. When we look at clinical success, meaning patients that have less than 10 collarettes, we actually saw 100% of the patients get to this level of treatment with both the BID or the TID dosing.
Interestingly enough, we didn’t really see a difference between BID or TID dosing, so I think for our patients, it’s safe to say that just stick with the BID dosing for XDEMVY or lotilaner. In addition, we looked at the patient’s quality of vision, their functional meibomian gland effects, and, again, we saw a significant improvement in meibomian gland function. Whereas in the study nobody had clear gland secretions at the beginning of the study, at the end of the study, we actually did see in the treated patients, the active treated patients, that they started to have a clearing of their meibomian glands. On average, in looking at 15 glands, about 5 glands or a third of the glands actually had clear secretions. That definitely translates into quality of vision and improvements for our patients.
At the beginning of the study, in both the vehicle as well as the active arm of the study, about 55% of patients had visual fluctuation at the beginning of the study. When we look at the patients out at 85 days, that was significantly reduced to about 13% in the active group, whereas the vehicle group really didn’t have a significant change in their visual fluctuation. The same thing holds true for ocular itching as well as redness. Patients had significantly less redness; as well as ocular itching was reduced greatly in the study as well. In summary, we have looked at the ability to treat patients a little bit longer than our traditional treatment of 43 days. We can actually see a significant benefit in meibomian gland function, which translates into improvement of quality of vision for our patients. Thank you very much.
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