Phase 4 study shows that switching cyclosporine formulations can improve patient outcomes
Brandon Ayers, MD, of the Wills Eye Hospital, discussed outcomes of a study presented at the American Society of Cataract and Refractive Surgery Annual Meeting that found that switching from cyclosporine 0.05% to cyclosporine 0.09% quickly improved patients’ dry eye symptoms and outcomes.
Brandon Ayres, MD:
I think that this is a really interesting study and it gives us a little bit more insight into does the formulation of a medication or of a chemical make a difference? This is a phase 4 study looking at patients with dry eye who were all treated with cyclosporine 0.05%. These are patients who were not necessarily unhappy with their treatment, but didn’t feel as if they were getting enough out of their cyclosporine 0.05%. The big idea or the general census was, well, what happens if we put them on cyclosporine 0.09% and a nano micellar solution, which is Cequa, and see if that makes a difference. Really it’s the same active ingredient, a little higher concentration in Cequa versus generic cyclosporine and Restasis, but the formulation is different.
Essentially, there were collections of dry eye patients and they had to have real dry eyes. I think SANDE scores were greater than 40 and they had to have at least a reasonable amount of corneal fluorescein staining and have been on Restasis for a significant amount of time. They weren’t 1 week failures or 2 week failures. These are patients who I believe on average were on Restasis for over 38 weeks. They really did give it a try. Then take that cohort of patients and switch them over to Cequa, which is cyclosporine 0.09% in a nanomicellar solution, and then see if they do any better. Lo and behold, they do. After just a couple of weeks of switching to Cequa, we saw a significant drop in their SANDE score. SANDE is the symptom assessment in dry eye. Then the total corneal fluorescein staining is basically looking at the number of punctate care on top of their PEE in 5 different quadrants on the cornea.
Really it only took about 4 weeks to show, within 4, certainly up to 12 but it kept improving. A change or improvement in corneal fluorescein staining and a various significant improvement in SANDE scores. Patients were not only looking better on exam, but also feeling better. I think that answers a pretty interesting question because sometimes when you’re talking to your dry eye patients and they’re saying, “Well, I’m doing okay, or I wish I was doing better.” You sort of wonder, well, if you’re already using either Restasis or generic cyclosporine, does it make sense to switch to another formulation of the same medication or should I switch to a different class? This really shows that staying even within that same class of anti-inflammatory, but using a more effective carrier can completely change how that medication works and can take a patient who’s not been real happy and make them happy again. Take a patient who may not have seen significant improvement on their clinical signs and symptoms and turn that around.
I think that’s an important question to answer because it really is the carrier that makes the difference. You can have a great medication, but if it’s not getting to the target tissues, if it’s not doing a good job, it’s not doing its best for that patient. Changing to a more effective application of that same medication can do better. It is okay and probably preferable to take a patient who’s not doing well or is doing ho-hum on Restasis and switch them over to Cequa and you’ll likely see improvements in signs and symptoms. Almost 69% of the patients preferred Cequa over their Restasis. Not only did they feel better, not only did they look better, but they had themselves a preference to use Cequa. Cequa is not the same as your generic cyclosporine or Restasis. It seems to work better and more effectively.
Something that’s important I didn’t highlight too much, this was a 12-week study, but the idea that cyclosporine takes 2 and 3 months to work is out there. That is true, the anti-inflammatories as a class do take a little while to really kick in. But you can start to see effect, well, in this study as early as four weeks. You don’t have to wait 2 or 3 months to see effect in your patients. They will start looking and feeling better really pretty quickly, in this study within four weeks after changing the medication. It doesn’t necessarily follow that stereotype that it’s going to take two months before you see any effect at all.
