Case study in disruptive innovation: Restasis and the treatment of dry eye

OSN takes a look at how the introduction of Restasis and the start of dry eye centers disrupted ophthalmic practice.

Issue: April 25, 2016

At OSN New York 2015, Ocular Surgery News held a symposium on disruptive innovations in ophthalmology, discussing new diagnostics, devices and therapeutic treatments that could be considered disruptive. This series will take a look back at disruptive innovations in ophthalmology that took place to examine how and why they were able to change ophthalmic practice.

In this installment, OSN spoke with David LeCause, vice president of U.S. eye care sales and marketing at Allergan, about the introduction of Restasis (cyclosporine ophthalmic emulsion 0.05%) as a treatment for dry eye and how that introduction helped drive new innovations in the dry eye market as well as the dry eye center.

Ocular Surgery News: How did Restasis disrupt ophthalmology and specifically how dry eye was treated in the eye care practice?

David LeCause: I think of disruptive innovation as being any kind of breakthrough that taps into unfulfilled needs within an existing market and truly alters traditional thinking. In many cases that results in the creation of an entirely new or different market category, and I think the introduction of Restasis is a classic example of that.

If you think back on where the dry eye market was before the Restasis launch in 2003, dry eye disease was poorly understood. It was widely viewed as a relatively low priority and, in a lot of cases, a nuisance by many clinicians. Treatment at the time was entirely focused on palliative care through a variety of over-the-counter artificial tear offerings. As a result, you had millions of patients who were undiagnosed or frustrated with available therapy and a lot of clinicians who were not paying much attention to the disease itself. I think Restasis changed all of that.

On our end, the breakthrough occurred because Allergan scientists understood that inflammation was a core contributor to the underlying disease, and they were able to develop a prescription dry eye product that, for the first time, addressed the true issue. Just as important, they were able to recognize the value of using a complex emulsion to deliver that drug effectively to the desired site. When the product got approved in the U.S. and was launched in 2003, it created a huge shift in how dry eye was viewed in this country. Awareness and understanding of dry eye as a significant and progressive disease have improved dramatically over the past 10 or 12 years. Eye care professionals, technicians and even patients have a deeper understanding of the etiology of the disease itself, its progressive nature and all the appropriate treatment options that are available.

OSN: The OSN Disruptive Innovations symposium dealt with many new dry eye products that have recently come to market or are on their way. What role did Restasis play in creating the environment for these drugs and devices?

LeCause: As awareness has increased and as the market has grown for dry eye in the U.S., we have seen exponential growth in the available technology to screen for the disease and to diagnose and manage patients, and we have point-of-care diagnostics. None of those existed 10 or 12 years ago, before Restasis was launched into the market.

I think as the market has grown it has been more attractive commercially, and so you get a much heavier investment in patient and provider education. You get a lot more spending on research, which has never been higher in this area, and that is great news for clinicians and patients. I think of this as a classic example of disruptive innovation stemming from the introduction of Restasis on the U.S. market.

OSN: Another way Restasis has been disruptive is the change in the approach to treating dry eye over time by clinicians. When Restasis first entered the market, many surgeons seemed to be dismissive of spending time treating dry eye vs. the multitude of dry eye centers opening today. Would you say that is an accurate assessment?

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LeCause: I think a lot of what has driven that has been better understanding of the disease by clinicians and a much better informed consumer base because they have access to a lot of information that is specific to dry eye. You have this increase in understanding on the clinical side, this groundswell of interest and education on the consumer side, and I think the demand is really what drove that. The third piece of that is we have an option now, an actual therapeutic option, that truly treats the disease as opposed to just covering symptoms or providing palliative care. And so, I think those three things together are what really caused this whole area to explode.

OSN: How did the specific market research come about?

LeCause: I have been in eye care for more than two decades. This category, I think, was the first category in which there was a lot of effort put into understanding the consumer. Over the years you have seen Allergan probably lead the charge in conducting a lot of significant and well-crafted consumer research, which helped us understand who these patients were, what their needs were and what their motivation was to seek care. We used a lot of what we learned to inform very significant direct-to-consumer advertising campaigns and education for patients, but I think we also shared a lot of information with clinicians so that they could better identify these patients when they presented within their practices.

OSN: Do you see industry being more collaborative in researching dry eye and sharing and trying to lift all boats within these dry eye centers?

LeCause: I think you will continue to see that. There are still an awful lot of undiagnosed dry eye patients in the U.S. Our latest figures show it is somewhere between 28 million and 30 million dry eye sufferers in the U.S., and there is a very small percentage of those who are under the care of an eye doctor or are being actively treated. There is still a huge need to increase awareness, to increase screening and to offer these patients alternatives that exist today that they may not even be aware of.

OSN: Taking a look down the road 5 to 10 years, where do you see the dry eye space?

LeCause: Dry eye disease is only going to get more attention and get bigger because of the demographics I just described. Because there are a lot of undiagnosed patients and because there is an explosion of new technology in this area, I think it will continue to get an awful lot of attention going forward.

Our approach at Allergan in terms of how we want to address dry eye is focused on building out what we are calling a “supermarket” of treatment options. We have existing products, and we have had a leadership position in this category for a long time with artificial tear lines under the brand name of Refresh, and the hallmark product in this category is Restasis, but we have the potential of launching at least five new products into dry eye probably over the next 5 to 7 years. I think you will see us try to build out a whole array of options for clinicians.

In the near term, we are actively pursuing approval of a multi-dose preservative-free bottle for Restasis, so that would be a first-of-its-kind container with a patented unidirectional valve. That would allow a preservative-free prescription product to be delivered in a bottle for the first time here in the U.S., and it should greatly improve patient compliance.

We have also gone out and acquired some new technology. We acquired a company by the name of Oculeve that has a product that will be the first neurostimulation device in the ophthalmic space, which we expect to launch sometime in the next year. We also have a number of other new therapeutic molecules that are in our laboratories or that we have licensed. We are looking to build out a whole array of options to capitalize on and fuel the growth of this category.

For more information:
David LeCause can be reached at Allergan’s U.S. administrative headquarters located at Morris Corporate Center III, 2525 Dupont, Irvine, CA 92612.

Disclosure: LeCause reports he is vice president of U.S. eye care sales and marketing at Allergan.