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Substantial changes likely in eye banking, corneal transplantation community
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The Eye Bank Association of America was founded in 1961. It remains the major organization representing eye banking in the world. There is also an International Federation of Eye Banks. The EBAA mission includes eye bank and technician certification, education, support of research and development, and advocacy with federal and state government regulatory agencies.
I have been involved with the Minnesota Lions Eye Bank (MLEB) since 1972 when I was a medical student doing research on corneal preservation with the now deceased Donald J. Doughman, MD. I continue to serve the MLEB today as an associate medical director. I have served two terms on the EBAA board of directors. I have received the R. Townley Paton Award and the National Ambassadors for Corneal Transplant Award and given the Castroviejo Lecture. I remain an active corneal surgeon and serve on the board of directors of SightLife Surgical, a new for-profit company dedicated to supporting innovation in the cornea field in partnership with SightLife and other not-for-profit eye banks committed to the mission of eradicating treatable corneal blindness worldwide by 2040. Optisol GS, which remains the most popular corneal preservation media in the world, was developed in my laboratory, and I hold patents on its formulations and the methods for its use, which have been licensed to Bausch + Lomb. Bottom line, I am quite immersed in eye banking, keratoplasty and promoting innovation in the cornea field.
In the following paragraphs I would like to share a few thoughts on the future of eye banking and keratoplasty. Several of my thoughts will be somewhat controversial, but my mind is one that is always looking to the future.
Corneal preservation, eye banking and keratoplasty have been a part of my life for 45 years. As a resident in ophthalmology at the University of Minnesota, I harvested eyes in the morgue, and the corneal preservation method was to place a couple of Neosporin drops on the whole globe, place it in a small jar with a moist piece of gauze at the bottom and put the jar in a refrigerator, in many cases — to the dismay of my wife and children — often initially at my home. With this so-called “moist chamber” method of corneal preservation, a transplant needed to be performed in 24 to 48 hours at the longest, so most were done as emergencies in the middle of the night.
In the late 1970s, Bernie McCarey, PhD, and Herb Kaufman, MD, developed MK corneal preservation media using TC 199 tissue culture media with the addition of 5% dextran for preserving a resected donor scleral rim. This gave the surgeon 72 to 96 hours to connect the donor to a patient, but keratoplasty was still an emergency and there was an inadequate supply of donors to meet the demand. Every corneal transplant surgeon had a list of Americans needing a transplant, usually a penetrating keratoplasty. In Minnesota, a rural state, many patients came from hundreds of miles away in the dead of night with a Minnesota State Highway Patrol escort for their corneal transplant. Their corneal transplant was performed at the University of Minnesota Hospital, and they were admitted to that hospital for 10 days.
Research and development, some of it in my laboratory at the University of Minnesota working with my cell biologist partner Debra Skelnik, revealed that adding 2.5% chondroitin sulfate to the more complete minimum essential tissue culture medium along with select antioxidants and 5% dextran could extend corneal preservation up to 14 days at 4°C. Today, the resultant Optisol GS, sold by Bausch + Lomb, and Life 4°C, sold by Numedis, dominate corneal preservation in the U.S. In other countries, 34°C organ culture storage also remains popular, supporting 28 to 35 days or preservation time allowing HLA and blood type matching, which have proven useful in the more genetically homogenous European patient. Both have extended corneal preservation times such that keratoplasty can now be an elective procedure scheduled like any other eye surgery, and the extended preservation time also allows the global sharing of donor corneas, which can be shipped by air anywhere in the world in 24 hours.
At the same time corneal preservation was becoming more sophisticated, donor awareness and registration programs in the U.S. and a few other advanced countries were significantly expanding the number of corneas harvested each year by eye banks and procurement agencies. Corneas harvested in the U.S. in 2017 will approach 140,000, with at least 85,000 being of adequate quality to be used for a human transplant. This is wonderful, but only about 50,000 keratoplasty procedures will be needed in the U.S. this year. In 2017 in the U.S., about 18,000 will be used by about 1,200 corneal surgeons for penetrating keratoplasty, 24,000 for Descemet’s stripping endothelial keratoplasty or pre-Descemet’s endothelial keratoplasty, 6,000 for Descemet’s membrane endothelial keratoplasty, and 2,000 for deep anterior lamellar keratoplasty and other lamellar keratoplasty.
There will therefore be approximately 35,000 transplantable U.S. corneas that are not needed by an American patient. However, the global need for a transplantable donor cornea is enormous. Some estimate that there are as many as 10 million corneal blind in the world that could be helped with a keratoplasty. Thus, excess tissue is easily exported. Unfortunately, the economics of exporting a transplantable cornea from the U.S. to a distant country creates a significant financial burden for a U.S. eye bank. Depending on the scale and efficiency of an individual U.S. eye bank, it costs $1,500 to $2,500 to procure, process and distribute a donor cornea. Advanced preparation techniques such as the cutting of a DSEK or DMEK graft increase the cost significantly. Donor corneas can be placed in the U.S. at $3,500 to $5,000, so harvesting, processing and distributing a donor cornea from a U.S. eye bank to a U.S. surgeon for use on a U.S. patient is economically viable. Unfortunately, many emerging countries can only afford to pay $50 to $200 for a donor cornea. Thus, most corneas exported abroad are done so at a significant loss to the U.S. eye bank. A simple economic analysis will immediately reveal that every eye bank would like to place as many donor corneas as possible in the U.S. or send them to those few countries that can pay U.S. prices.
Because most eye banks are processing and harvesting more corneas than they can place in their own communities, there is now a new and growing competition among eye banks for corneal surgeon customers. The decision-maker on corneal tissue access for a transplant today is the corneal surgeon, and we corneal surgeons are now being aggressively wooed by multiple eye banks to utilize their tissue. This competition among eye banks for the corneal surgeon customer is new and for many traditional eye banks uncomfortable. Eye banks that provide Ritz-Carlton service and differentiated corneal tissue offerings, such as DMEK precut, stained with trypan blue and loaded into an injector or ultrathin DSEK or PDEK with or in an injector, are seeing their tissue placements grow at the expense of some less well-funded and innovative eye banks. Some eye banks are starting to fail as their costs increase and their placements decrease. Other eye banks are merging with or being acquired by larger eye banks or joining regional networks, which I predict will eventually become global in nature.
I believe eye banks will soon resemble on a smaller scale the major strategic corporations that provide us with our pharmaceuticals and devices in fields such as cataract surgery, glaucoma and pharmaceuticals. Consolidation, which allows economies of scale and adequate resources to innovate, is a fact of life in medicine worldwide, and eye banking and corneal surgery will in my opinion be no exception to the wave of consolidation being experienced in fields of medicine in the U.S. In addition, while the U.S. supply of transplantable donor corneas is increasing every year, the U.S. and advanced country demand is likely to decline. Corneal collagen cross-linking is reducing the number of transplants required for keratoconus. DALK and the various forms of endothelial keratoplasty are driving down the number of PK procedures.
The next innovations will include simple descemetorhexis with Rho-kinase inhibitor pharmacotherapy or an endothelial cell transplant with or without Rho-kinase inhibitor rather than a DSEK, PDEK or DMEK for Fuchs’ dystrophy and pseudophakic bullous keratopathy. A single young donor cornea might provide enough endothelial cells for hundreds of endothelial transplants. In addition, synthetic silicone endothelial membrane transplantation is showing promise for treating corneal edema patients with the promise to eliminate the need for human donor tissue or cells at all. Work continues on a synthetic artificial cornea for PK, which would be wonderful for the 10 million global cornea blind, many of whom have vascularized corneas from trachoma and other infectious disease with a high rejection rate using live tissue. If successful, transition to synthetic corneas will be financially devastating to the eye bank that is sustained by procuring, processing and distributing human corneal donor tissue.
The megatrend I see in the U.S. is more and more transplantable donor corneas being harvested each year in the face of ever declining U.S. demand. This will put enormous financial pressure on all but the best-managed eye banks. Every innovation I see coming in keratoplasty is likely to reduce the number of donor corneas required and increase the cost and sophistication needed by an eye bank to meet the demands of an ever more demanding corneal surgeon and regulatory environment. When I started in eye banking, there were nearly 100 eye banks in the U.S. In 2016, only 62 eye banks reported their statistics to the EBAA. My expectation for 10 to 20 years from now is that as few as 10 large consolidated eye banks in the U.S. will remain economically viable. Even more controversial, one or more of them will be owned by a publicly traded for-profit company or perhaps even a major global strategic. In addition, these large eye banks will be competing with one another for every individual corneal surgeon’s business, much like Alcon, J&J Vision and Bausch + Lomb compete for the cataract surgeon’s IOL business today. That will be a big change for the smaller single-city or state-focused eye bank of today that provides donor tissue primarily to local surgeons.
The only constant in life is change, and in the next decade, I see significant change coming to corneal transplantation and the eye banking community.
Disclosure: Lindstrom reports he receives royalty from, is a consultant for and has ownership interest with Bausch + Lomb, and is on the SightLife Surgical board of directors.