The problem that we're addressing is specifically glaucoma. But in a more general sense, it's the issue of bioavailability of eye drops. So any medication that's administered as an eye drop is subject to all of the biological processes that cause your eye to remain safe on any given day, and exposed to any number of external conditions. But that also cause eye drops to be horribly inefficient, and so this happens with pretty much any eye drop. But in glaucoma, it's of particular concern. Because those eye drops, the drug needs to be given in order for the disease to be controlled. If it's not, it's progressive and chronic, you'll continue to get worse, and you can lose vision. It's irreversible, so you never get that vision back. With glaucoma, there's other issues. It's painless, so people don't have a constant reminder to take their drops. So you have all of these things working against patients to administer the right amount of drug, and your eye is designed to really not allow things to reside on the ocular surface for that long. So you're just not getting the right penetration of drug, and this is a well-established and understood need in ophthalmology, and it occurs for lots of other conditions as well. The use of anti-inflammatory drugs, anti-infectives, and so there's lots of opportunity here. But glaucoma is also a huge market. So it is the second leading cause of blindness worldwide. The incidence of glaucoma is expected to increase significantly with the aging population, the baby boomer generation that's aging into those peak years for glaucoma diagnoses. So that's why this is not only a very serious clinical concern, but there's also lots of people, and lots of money in the treatment of glaucoma. It largely came about the evolution of how I became familiar with glaucoma and ocular drug delivery. I would really credit that to Jo Schuman who was our clinical collaborator. It seems so common place now to say you need an engineer and a clinician, everybody has this dream team. But I think that people see it as just like a formality that, "Okay. I need someone to be on here." But to really utilize and tap into that expertise is very powerful because a practicing clinician has an understanding of the day-to-day inner workings of a clinic, or what goes on with a patient, or a disease that we just couldn't possibly understand. So to sit down and not just say what's the problem as you would see it in like the introductory slides of a talk, but to say how does this affect your patients in their daily lives? How does this actually manifest in your clinic? That was where I really began to understand what makes this a bigger problem. From there, things like the biology and the different transport processes that are happening, that stuff comes easy to an engineer. But understanding the clinical manifestation of this was something that without a really involved clinical collaborator, I never would have gotten that. We wanted to increase the residence time of the drug at the surface of the eye, in or near the eye, anywhere there about. We have lots of different ways of doing that, we can prolong the release of drug. So we started doing it the same way that we would do with any other disease, and then it was only over time that we began to realize that not only is it a delivery issue. So the amount and the timing of drug release. It also has to do with, will a patient ever actually be willing to use this? For instance, we had started looking at a contact lens that was loaded with drug, and it seemed to make a lot of sense because you wear a contact lens, it's right up against your eye. Surely, you're going to get enough drug going in there, but then we thought about it and we're like, "Well, who else is very in adherent to their prescribed regimen contact lens wear?" I wear contact lenses and I can't even be bothered to wear them for the right amount of time before changing them. So we were worried that we were going to take one problem and replace it with another problem. So we started to think more about end-use, and what a patient would be willing to accept, what a clinician would be willing to prescribe? So that changed our understanding of the problem dramatically, and we actually scrapped the entire contact lens idea, and started over with a different formulation.
