By Mark L. Dlugoss
Senior Contributing Editor
While medicine has recorded a history of remarkable accomplishments over the last 75 years, ophthalmology—along with cardiology and orthopedics—has documented a continuous flow of innovation. It appears to never end—and quite frankly, it shouldn’t!
In ophthalmology, technology is always changing. The ophthalmic field seems to be always looking for that “next big thing.” Whether it’s refractive lasers, phacoemulsification machines, approaches in glaucoma, or ophthalmic pharmacology, ophthalmologists always want to jump at the opportunity for the “next big thing.”
It is kind of funny. Once the FDA approves a new device or drug, it appears that ophthalmologists are quick to think, “Great, what else do you have? What’s next?” To be honest, that is a great attitude in medicine, and what makes it even greater is that the ophthalmic industry is quick to answer that call for the “next big thing.”
The amazing point about that kind of thinking is that along the way there is a lot of mishaps, setbacks, and even all-out failures. You could say that innovation has a price. However, what should be noted about failures/setbacks in ophthalmology is that there really isn’t any.
What I have observed over the years is that when innovation fails—or doesn’t achieve the clinical results physicians and industry expect—the actual concept is never abandoned. It’s basically “put on a shelf” for another time or it quickly learns from the past.
Down the line—maybe months, maybe years—other researchers come across the “failed” concept, look at it, re-evaluate it, and decide: “Let’s tweak it, and see if we can make this work.”
Low and behold, a new, improved version of the failed concept resurfaces. Sometimes the new version of the technology is a success, and sometimes, it is just another step in the evolution of innovation.
An example of this innovation process is the intraocular lens (IOL) market.
We all know the story behind Sir Harold Ridley and the first acrylic IOL. As an English ophthalmologist serving in the Royal Air Force during World War II, Ridley noticed an odd phenomenon while treating pilots with eye injuries.
When aircraft were hit by enemy fire, shattering the cockpit canopies, Ridley observed that the pieces of acrylic plastic found in the pilots’ eyes did not cause an inflammatory rejection in the eye.
After the war, Ridley pursued this observation and created the first acrylic IOL. However, after the first implantations in the United Kingdom and the United States in the early 1950s, the new IOLs were not well received. In fact, Ridley got a lot of pushback from the ophthalmic community and the medical community.
It wasn’t until the 1970s that acrylic IOLs began receiving acceptability among ophthalmic surgeons. During those first 20 years, Ridley basically tinkered and continued to improve his IOL concept.
However, in the late 1980s, IOL technology started to emerge with the development of multifocal IOLs. These new IOLs utilized the optical principles of diffraction and refraction.
The early refractive designs, made of polymethyl methacrylate (PMMA), presented a two-zone refractive multifocal IOL—with a 2-mm central, 4-diopter addition zone, surrounded by a large distance zone. These IOLs offered good results, but their success depended on proper centration of the lens and the right pupil diameter.
Soon, other refractive models began to emerge. The newer concepts started with a three-zone design—two distance zones and a near zone. Other ophthalmic companies started to develop refractive IOLs offering various near and distance zones.
At one point, there were multifocal IOL designs that featured up to seven zones. Unfortunately, the majority of these designs were not successful.
In the early 1990s, there was one shining moment in IOL innovation. Allergan Surgical (now J&J Vision) introduced the ARRAY lens, a PMMA model that featured aspheric and spherical optical surfaces. The lens had improved image quality because of its progressive transition between its five zones.
The ARRAY lens started out well, but eventually, it too was unsuccessful. Yet, a lot was learned from the ARRAY—not only in lens design but ophthalmic surgeons learned that proper patient management and the need for better pre-operative testing were required for better outcomes. All of these added elements helped the refractive models evolve to the IOLs we have today.
On the diffractive side of this IOL evolution, there was the 3M Co. Known for fostering a culture of investment in research and development that spurred innovation, 3M was always creating market-changing products. In the late 1980s, the company introduced its diffractive multifocal IOL that changed the ophthalmic market.
The 3M technology was a three-piece diffractive multifocal IOL that featured about 30 concentric rings on the poster surface of the lens. Each ring had a 2-µm height difference. The lens design was developed around the principles of diffraction outlined by an English physicist in the 19th Century named Thomas Young. (Here is a concept that sat on the “shelf” of innovation for 150 years.)
The 3M diffractive technology has evolved over the last 30 years into the central diffractive zone that combines both the refractive and diffractive principles into one lens.
As a result, innovation of these early IOL designs has lead to the creation of various lenses that are on the market today and in clinical development, including the newer multifocal lenses, phakic IOLs, toric IOLs, accommodating lenses, trifocal lenses, presbyopia-correcting IOLs, the extended-depth-of-focus IOLs, and other IOLs.
Successful innovation in the other segments of ophthalmology was also achieved on past failures and setbacks. Let’s look at the retina subspecialty.
Photodynamic therapy (PDT) with verteporfin (Visudyne, Novartis) surfaced in the early 2000s as the first major treatment for choroidal neovascularization in age-related macular degeneration (AMD). While the treatment worked with many patients, it was not the end-all cure for AMD.
Pegaptanib sodium injection (Macugen, EyeTech/Pfizer) followed. Many in the retina community had high expectations for this new treatment. It was probably the first anti-angiogenic medicine to address AMD, but again, it did not deliver on those expectations.
Researchers continued to analyze and develop other compounds in the anti-angiogenic arena. Their work lead them to anti-vascular endothelial growth factor (anti-VEGF) drugs.
The first anti-VEGF drug was ranibizumab (Lucentis, Genetech). This was followed by bevacizumab (Avastin, Genetech), a cancer drug that many ophthalmologists use off-label. Of course, all of this innovation led to aflibercept (Eylea, Regeneron).
Today, many of these same drugs—and others in the retina pipeline—are being evaluated and researched for other retina diseases as well, particularly macular edema and diabetic retinopathy. Meanwhile, many drugs in development are experiencing the innovative growth found in previous attempts to find a cure for retinal diseases.
If one reviews the innovation in all ophthalmic subspecialties, you will see similar sequences of failures, setbacks, and successes that have occurred in the IOL and retina markets. However, the lessons learned from the history of all of the ophthalmic innovation are that there are no “total” failures.
Ophthalmic technology is never abandoned or considered a complete failure. It simply evolves!
The Ophthalmic Project is a series of blogs and podcasts written and produced by Mark L. Dlugoss, senior contributing editor. The Ophthalmic Project will address trends, events, and observations in the world of ophthalmology. Dlugoss has nearly 25 years of experience covering the ophthalmic market.