What has happened to the Eyepass, and what did you learn from the experience?
The Eyepass was the first device to bypass the trabecular meshwork and to direct aqueous from the anterior chamber into Schlemm's canal. Although the early experience with the technology was encouraging, the results of the phase 3 study were not as good as we expected. The sponsor, GMP Companies, Inc. (Fort Lauderdale, FL), did not think that the device would achieve FDA approval and abandoned the study. In addition, the company was experiencing cash-flow problems and was reorganized. Glaukos Corp. (Laguna Hills, CA) acquired the rights to the Eyepass, and my wife and I are no longer involved in the project. Although the device is approved in Europe, I do not think that Glaukos Corp. plants to continue its development.
It would have been wonderful if the Eyepass had been successful, because it would have generated needed momentum in the development of surgical devices for glaucoma. Unfortunately, there is no culture of innovation in this arena. A small number of people are dedicated to glaucoma surgery and the development of surgical devices, but what is needed is an industry-wide approach. The fact that no major ophthalmic manufacturer has a division dedicated to glaucoma surgery illustrates the problem. Currently, companies are built around a specific device, and that technology (and thus the company) either makes it or does not. Without a substantial investment by a large, established company in the research and development of new surgical options for glaucoma, it will be very difficult to move forward. It takes so much money to get started, and FDA approval is an enormous challenge. What we need is a company that has the money to make a long-term commitment to glaucoma surgery and to look at multiple devices and surgeries.
What frustrates you the most about the subspecialty of glaucoma?
One of the problems is that we do not understand outflow. We have many assumptions based on limited data, and those assumptions may not be true. We do not know how fluid flows in the trabecular meshwork or the collector channels, and we do not have a way to follow outflow. We have no angiogram, and I think that is one of the main things we need in order to solve the problem of glaucoma surgery performed with an internal-drainage approach.
The problem affects all of the internal treatments being explored in the field of glaucoma. For example, when a canaloplasty is ineffective, no one knows why. It is not possible to look at an angiogram and say that the intervention is not working because the suture was not sufficiently tight or the collector channels were not accessed in a wide enough area. All we know is that the procedure did not achieve the target IOP. We are taking shots without knowing exactly what we are aiming at, and we are basing our assumptions on work done partly by Morton Grant, MD, decades ago. Unfortunately, it is hard to drum up industrial support for the development of a form of angiography that only studies outflow and does not treat glaucoma. There are also technical problems, because aqueous outflow is so slow that it is not amenable to the usual angiographic technologies.
For me, a major source of disappointment is that the subspecialty of glaucoma is dominated by medical therapy. At the major manufacturers, I think that the money and energy that would be put into a surgical program are viewed as coming out of the pharmaceutical division. That is a shame. Patients with red, uncomfortable eyes who are taking three or four medications and spending huge amounts of money are classified as examples of successful treatment. A disease that has such a long duration and is so difficult to treat medically, however, is in many ways much better suited to a surgical approach. Nevertheless, I do not view the pharmaceutical/surgical question as having an either/or solution. Even if we had a great operation for glaucoma, eye drops would always be important as an adjunctive therapy. The catch is that we need a glaucoma surgery that is both safe and successful, and we do not quite have that procedure yet.
How do you envision glaucoma surgery in 10 years?
There will be breakthroughs. There are so many smart, dedicated people trying to develop better technologies that something is going to happen. The market for an effective glaucoma device is potentially in the billions of dollars, and such technology is desperately needed by patients.
I am still optimistic that there will be a cataract-like operation for glaucoma that can be completed in 20 minutes or less, has a high rate of success and few complications, and requires minimal follow-up. Such a procedure would compete effectively with medical therapy, and I think it would lead to a paradigm shift in treatment. The patients who could benefit from the operation are already in our clinics; we do not have to reach them through advertisements. A breakthrough glaucoma surgery would be good for them as well as for surgeons and industry.
Can patients with glaucoma benefit from recently approved IOL technologies?
Absolutely. Historically, doctors have used new cataract technologies in patients with glaucoma last. This is partly an appropriate reservation about increased risk. These individuals, however, deserve all of the technological benefits afforded to other patients.
Just as surgeons eventually came to use phacoemulsification and IOLs in patients with glaucoma, this population will ultimately fully benefit from premium lens implants. Toric lenses work just as well in glaucomatous as in healthy eyes, and I use these IOLs a lot for patients with glaucoma. I have also found that accommodating and aspheric IOLs work well in this group. The controversy today mainly regards the use of multifocal lenses in patients with visual field loss and whether they see as well postoperatively as they would with other IOL designs.
One of the interesting things to me about the new IOL technologies is the emphasis on eliminating astigmatism. I think this focus on refractive cataract surgery is going to affect glaucoma surgery. A widely successful glaucoma procedure cannot create astigmatism. A trabeculectomy will therefore be an impossible operation for the future. Cutting out pieces of the sclera and making large incisions induce too much astigmatism. The future of glaucoma surgery has to be devices, not creating holes.
What prompted you to transition from academic to private practice 9 years ago, and is there anything you miss about the university setting?
I was not an ideal fit for an academic center. I am mainly a clinical doctor, and I like trying to develop devices for glaucoma surgery. Those two pursuits really take up all of my time, so it was hard to fit in the other demands of an academic role. I have found that it is easier to conduct research and to manage my time since I entered private practice. I also really like having my own business.
I miss having other specialists close at hand, however, and perks like having a photography department and grand rounds. I especially miss being able to discuss cases so easily with colleagues.
