Daniel White and I had worked together on multiple projects and at different companies. Thus, I was excited when Dan called me and asked to meet at the American Academy of Ophthalmology meeting in 2010. I met with him in a small hallway off the convention center floor along with some members of a research team from Georgia Tech. They showed me a hollow, micron-scale needle that they had developed to inject drugs into the suprachoroidal space (SCS), explaining that this was going to replace intravitreal injections.
I was intrigued but skeptical. I was sure this would be one of the most painful things we could do to a patient. After all, a suprachoroidal hemorrhage is one of our most feared complications during surgery, and injecting with this needle would surely cause many. Moreover, how could you monetize a needle? This was like being FedEx: you can deliver stuff, but the stuff in the box was where the money was.
Dan was not deterred and soon founded Clearside Biomedical with $4 million in Series A capital around this innovative delivery device. In a brilliant move, the device was paired with triamcinolone, a low solubility steroid, that could be delivered through the needle into the SCS. We tested the needle in animal eyes and then human donor eyes. The procedure seemed very straightforward, but would it work? We designed the first human studies, and I asked to see videos — with sound — of the first treatments. I was curious if my misgivings would be true. Would the patients scream in pain? Would there be an immediate suprachoroidal hemorrhage?
It turned out that all my worries were for naught. The patients tolerated the procedure well and, more importantly, steroids in the SCS worked: Xipere is now FDA approved.
It is hard to believe that this entire issue is based on that little needle I saw in a conference center back hallway. Therapies that were not even dreamed of at that meeting are now being delivered through the needle, including gene therapy and tyrosine kinase inhibitors. I asked a leading retina expert in SCS technology to be the guest editor for this issue. Dr. Mark Barakat has extensive experience with the device in clinical trials, and he has developed a great issue. We hope you enjoy it. RP