How for-profit entities are changing the game in eye banking
In the previous issue of CAKE Magazine, we discussed the not-for-profit model of eye banking and corneal donation. In this issue—to provide a balanced perspective, we will explore the other side of the coin: The for-profit model and its mission, including its history, while also dispelling a few myths along the way!
Dr. Samera Ahmad, a fellow in corneal and external diseases at the Bascom Palmer Eye Institute in Miami, Florida, holds a Master’s in Bioethics with a focus on eye banking—making her an expert on this topic and its ethical implications.
“Eye banking has changed significantly in the last several decades, and for-profit eye banking raises many challenging ethical questions. After all, any for-profit endeavor in a donation-based space is bound to provoke scrutiny,” noted Dr. Ahmad.
To gain a better understanding of some of the questions and concerns raised by corneal surgeons and eye bank leadership, Dr. Ahmad and colleagues from Emory University conducted an interview study involving 50 US-based corneal surgeons and 25 eye bank leaders. The findings were published in the journal Cornea in 2020.*
“We found that the majority of corneal surgeons interviewed held some ethical concerns with the emergence of for-profit eye banking,” Dr. Ahmad shared some of the study results. “One major concern was that people fear that could dissuade future donors if they were to hear about it, and I think that is a valid concern.”
Interestingly, many participants also recognized the potential benefits of the for-profit model. “On the other hand, many feel that the research and development initiatives spurred by for-profit entities could justify their approach,” she noted.
The role of investment in eye banking
To learn more about the for-profit model, we spoke with Mr. Bernie Iliakis, who has been involved in eye banking since 1995 and currently serves as the president and CEO of CorneaGen, a Seattle-based forprofit ocular tissue processor and distributor.
Mr. Iliakis discussed the role and impact of CorneaGen, providing some historical context about the for-profit model and its implications for surgeons, patients, donors and researchers.
“CorneaGen was established in 2016, bringing in more than $160 million in investor dollars to the cornea space—resources that would not have existed otherwise—all to fulfill the vision of transforming the lives of everyone impacted by corneal disease. Fundraising through a non- profit would not have come close to reaching this level of investment,” he explained.
As those of us in the research space know too well, funding is important to help translate benchside innovations into clinical advancements and bedside applications.
CorneaGen and Mr. Iliakis also recognize the benefits and advantages of funded innovation. “We knew external capital investment would be critical to make innovation possible. Our primary investment has been Aurion Biotech, which is bringing endothelial cell therapy to market in Japan and is currently undergoing FDA clinical trials in the US. A for-profit can push new technologies forward, benefitting the entire industry,” continued Mr. Iliakis.
Mr. Iliakis highlighted some of the innovations that have come to fruition from investments in the for-profit eye banking model. “Our efforts have achieved incremental advances in corneal processing and tissue delivery, as well as significant, new FDA-approved devices like the EndoSerter®-PL, a preloaded graft insertion device for corneal transplant,” he said.
“Additionally, CorneaGen has announced the commercial availability of Corneal Tissue Addition for Keratoplasty (CTAK) in 2024—a solution for keratoconic eyes, maximizing the use of each corneal donation. Innovations like these not only optimize valuable time in the OR but also improve patient outcomes and expand the addressable market for corneal tissue,” Mr. Iliakis explained.
Meanwhile, Dr. Ahmad also recognizes the benefit of well-funded research but believes that non-profits could play a similar role—though the path may be more challenging.
“Realistically, I think that non-profits could likely achieve a similar research mission, but it would require a strong ethos of collaboration among many eye banks to get there,” she noted.
Demystifying for-profit eye banking
For those of us who view for-profit tissue donation as a relatively new entity, Mr. Iliakis clarified that this is not the case.
“For-profits in tissue banking— including skin, bone, heart valve, ligament and more—have been in existence for 25 years. According to the American Association of Tissue Banks (AATB), 50% of tissue banks in the United States are for-profit and have directly contributed to advances in musculoskeletal surgery and tissue products. Therefore, this is not a new concept in organ and tissue donation,” he explained.
“In fact, the first for-profit eye bank was the first to precut tissue for Descemet stripping automated endothelial keratoplasty (DSAEK) in 2004,” shared Mr. Iliakis. “With improved tissue quality and reduced waste, non-profits soon followed— making this for-profit innovation the standard of care for endothelial keratoplasty today.”
He further noted that the for-profit corneal tissue banking model isn’t some kind of underground secret society. “For-profits exist throughout the cornea donation and transplant environment, including surgery centers, hospitals, funeral homes, transport agencies and more.”
Ethics versus financial dynamics
As for Dr. Ahmad, she believes that the for-profit model is likely here to stay, but emphasized the importance of keeping ethical implications at the forefront.
“I don’t think for-profit eye banking is going anywhere,” she said. “But it is important to ask salient ethical questions as we move forward. The for-profit business model itself doesn’t carry any ethical weight, but the conduct of an eye bank does.”
Ethics is central in the discussions surrounding for-profit entities, and Mr. Iliakis provided valuable insights into the ethics and financial dynamics of both non-profits and for-profits.
“Some may argue that it is unethical ‘to profit off the donation of tissue,’ claiming that this ‘commoditizes’ the donated gift. However, if you look at the public Schedule 990 of any non-profit eye bank, you’ll see profit margins in the 5% to 20% range. Some non-profits are sitting on reserves of $10 million to $100 million instead of using those funds to support innovation,” he explained.
The differences between the two models may not be as clear-cut as we originally thought. “These nonprofit organization reserves were built through ‘processing fees’ collected over years from ‘donated tissue.’ Essentially, the business model of the non-profit and for-profit eye bank is identical,” Mr. Iliakis continued.
“The processing fees allowed for the tissue are the same. The key difference is that for-profits pay taxes on any year-end profits, whereas nonprofits do not. Moreover, many nonprofit eye banks and associations are now directly investing in and taking ownership of for-profit ventures. The lines between these two models have blurred and contradictions abound,” he said.
Hypocrisy or competition?
Mr. Iliakis recalled that not long ago, a bill had quietly passed in the State of Kentucky that limited a surgeon’s ability to choose their provider of corneal tissue to non-profit eye banks only—thus, making it illegal for for-profit entities to participate in eye banking.
“This was a clear restriction on surgeons’ access to perform these life-changing corneal surgeries. Fortunately, this bill was ruled unconstitutional by the Circuit Court and upheld unanimously by the Kentucky Court of Appeals,” he shared.
Despite the ruling, the lines between non-profit and for-profit remain drawn. “For-profit eye banks are not permitted to be members of the Eye Bank Association of America (EBAA). However, the EBAA has recently allowed for-profit companies to be members, so long as they do not perform eye banking functions. This situation raises questions of hypocrisy and appears to be influenced by competitive concerns,” noted Mr. Iliakis.
In Dr. Ahmad’s study, one concern identified was that a for-profit model could hypothetically lead to a loss of donor trust and the potential exploitation of donor generosity.*
These are similar sentiments that CorneaGen has heard before, but Mr. Iliakis said this is not the case.
“An argument has been made that for-profits deter donations, but this simply isn’t true,” he argued. “If you look at the musculoskeletal donation model over the past 25 years, there has been no shortage of tissue for transplant in the US. Also, there hasn’t been a waiting list for corneal transplants in the past two decades.”
“A for-profit model highly honors and respects the gift of donation, often with as much or greater investment and awareness in organ, tissue, or eye donation. In fact, donor registry rates and general eye donation continue to increase year after year, regardless of the presence of forprofit entities in the space.”
Transforming cornea care
Despite the concerns and myths surrounding for-profit eye banking models, the benefits cannot be ignored.
“We [at CorneaGen] are proud of the work that we and other for-profit organizations have done to advance cornea care,” Mr. Iliakis enthused. “Our significant innovations, such as cell therapy, are made possible only through a for-profit model, investor capital and industry partnerships that are bringing new solutions to life.”
References
- *Ahmad S, Vong G, Pentz RD, Dixon M, Davis KW, Khalifa YM. Ethics in Eye Banking: Understanding Professional Attitudes Toward Industry Changes. Cornea. 2020;39(10):12071214.
Editor’s Note: To read the full non-profit take on eye banking in Part 1 of this article series, see page 16 of the previous CAKE Magazine Issue 23.
