Takeaway: there doesn't seem to be a specific dry eye phenotype that does better or worse.
This is a sub-analysis of a larger trial looking at a compound called OC-01 (varenicline solution) as a treatment for symptoms and signs of dry eye.
This larger study involved hundreds of patients that had different symptoms and signs compromising the dry eye umbrella. And the question we wanted to ask, because there are so many different phenotypes within dry eye, is: How would this compound do in patients with autoimmune-associated dry eye?
And we defined autoimmune pretty broadly: anyone who had an associated comorbid autoimmune disease. And the rationale for this is because the hypothesis may be these patients have a more severe dry phenotype and would be less likely to respond to treatment. And so that is the question that we aimed
We identified 31 people out of the larger trials who had a comorbid autoimmune disease, and we look to see how they did. This was a placebo-controlled study, so, how the cases who were treated compared to placebo, and how overall they compare to the larger study findings.
The punch line is that they did just as well as patients without autoimmune-associated dry eye. Which is great; it means that we're still trying to understand how OC-01 will be used in the general dry eye population, but it doesn't seem that patients with autoimmune disease do any worse than patients without autoimmune disease. And so that is the main takeaway, and a really important one for clinicians.
When you're looking at the data, the biggest wow effect was in terms of dry eye signs. A majority of individuals that were treated with OC-01 had a greater than 10-millimetre improvement in Schirmer at four weeks compared to controls. Symptoms, as is the case in most dry studies, were more variable. But either way, there was an improvement in both signs and symptoms. The side effects, most common was a sneeze, and most common were reported as mild, and that's in the whole population.
The takeaway of this study is that there doesn't seem to be a specific dry eye phenotype that does better or worse. And so we'll still have to look and see how this does in the global landscape of dry eye, but patients with autoimmune-associated dry eye did just as well as patients without autoimmune dry eye in responding to this compound.