SECO 2025: analysis of cyclosporine ophthalmic solution 0.09% for dry eye disease in patients with or without meibomian gland dysfunction
Joshua Johnston, OD, of Georgia Eye Partners, discussed a study he presented at SECO 2025, titled “Efficacy of cyclosporine ophthalmic solution 0.09% in patients with uncontrolled dry eye disease: a subgroup analysis in patients with or without meibomian gland dysfunction.” He spoke with Optometry 360 about the study’s findings.
Joshua Johnston, OD:
This most recent subgroup was presented at SECO here in Atlanta, Georgia. We initially presented this data at the Academy of Optometry in New Orleans 2 years ago, and that had some different outcomes that we were looking at. The big backstory on this was basically patients that presented on current therapy of cyclosporine 0.05%, and they were deemed to be not being well controlled, and that was either by 2 measures.
One, subjective complaints based on the patients reporting that they were symptomatic and didn’t feel like they were well enough covered. Or based on corneal staining from the inclusion criteria that was determined by the doctors in this phase 4 study. Some background notes that are important. We found that the patients had to be on Restasis for more than 3 months, cyclosporine 0.05% for more than 3 months of treatment. It wasn’t like they had used this for 2 weeks or 6 weeks and deemed a failure. They had been on it and it was working, but working not well enough for them based on symptoms or conjunctival staining based on the clinician’s determination data there. What was an interesting point as well, we found that the average mean had been on treatment for 38 months there. We know historically the longer we use this medication, the better things look and feel. The average mean was 38 months.
The data that was presented at SECO was an extension, a different subgroup of this different cut of the data that looked at 2 different things. Ultimately, what it looked at is patients with and without meibomian gland dysfunction based on the same thing. Were they having improvements in change from baseline of total corneal fluorescein staining if they had meibomian gland dysfunction or they didn’t? Also we also looked at lissamine green scores on the conjunctival tissue. Was there a change of baseline that was significant with those patients that had meibomian gland dysfunction, either with or without that?
Meibomian gland dysfunction in this case, it may have been self-reported by the patients or it was deemed to have been found in the previous medical records from these patients there. The endpoint, the primary endpoint was done at 12 weeks, but the baseline measurement was done and then measurements were done at 4 weeks, 8 weeks, and 12 weeks. Ultimately, the first thing we looked at again was can we decrease from baseline a statistically significant improvement in the total corneal fluorescein staining with those patients? It was found to be significant with and without meibomian gland dysfunction. The thought there is if you increase natural tear production with this higher version of 0.09%, ultimately we found statistical significance improving baseline staining changes in corneal fluorescein staining.
Again, if they were determined not to be effective based on signs and symptoms, they were then switched over, switched studies essentially going from 0.05% cyclosporine the next day given 0.09% cyclosporine there, which we know is a little higher concentration, but also has a unique nanomycelior technology. Ultimately we think delivering a little bit more bioavailability to these patients there.
Another sub-cat of this group, the subgroup was to look at again, the change in lissamine green staining scores on the conjunctival tissue with those without and with meibomian gland dysfunction. There was a primary endpoint again at 12 weeks. Fortunately, there was also a statistically significant improvement in decrease of those lissamine green staining on the conjunctival tissue in both subgroups, those with meibomian gland dysfunction as well as without meibomian gland dysfunction.
Again, I think the key points here takeaway, it was a fun paper to present at SECO this year. The surprising backstory on this study was that patients had been on therapy for a median average of 38 months there. It wasn’t like, again, they had tried this for a few weeks or a few months and failed it. They actually did respond, but they didn’t respond well enough based on staining and symptomatic improvement. This subgroup, again, looked at those with and without meibomian gland dysfunction. Can we decrease the amount of corneal staining as well as decrease the amount of conjunctival staining? It was statistically significant in both groups by week 12 there.
Another interesting point was that this primary endpoint was at 12 weeks on all these different subgroups that we looked at. But essentially almost every single one hit statistical significance at 4 weeks, 8 weeks, and of course at 12 weeks there. There were two groups in one set of the measures that did not. But basically majority of these patients did hit statistical significance in as fast as 4 weeks looking at this. It points to how well this 0.09% formulation works. The primary endpoint was at 12 weeks. But we did see it significant in a lot of these different groups by a week forward there, which was impressive as well. Looking at the speed of onset.
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