Reporting from the 2021 AAO Annual Meeting
November 12–15, 2021 • New Orleans, Louisiana
- Eyecelerator@AAO kicks off
- Digital health in ophthalmology
- Cornea spotlight
- Reimbursement
- Focused session on myopia
- Eyecelerator closes with awards and ‘eyes on the future’
Eyecelerator@AAO kicks off
The second Eyecelerator@AAO meeting took place Thursday in New Orleans, Louisiana, ahead of the American Academy of Ophthalmology (AAO) Annual Meeting. David Parke II, MD, AAO CEO, Steve Speares, ASCRS executive director, and Gil Kliman, MD, managing partner at InterWest Partners, explained the value of Eyecelerator, which was established in November 2019 as a partnership between ASCRS and AAO to bring the ophthalmic community, as Dr. Parke put it, a meeting that supports innovation and all who are part of the process, including scientists, business leaders, investors, regulators, and ophthalmologists.
Mr. Speares said getting together for the second in-person Eyecelerator meeting (the first of which took place at the 2021 ASCRS Annual Meeting in Las Vegas, Nevada) is exciting but also bittersweet. This was the last meeting with Dr. Parke at the helm of AAO before he retires. Mr. Speares expressed his “deep appreciation” to Dr. Parke for what he has done for AAO and for him personally. Stephen McLeod, MD, will become the new CEO of AAO.
Dr. Kliman provided some background on Eyecelerator, describing the partnership between AAO and ASCRS to create the organization as the first of its kind. Eyecelerator is mission driven with its main focus being to “get innovations to patients faster for better care,” Dr. Kliman said, adding that the organization plans to cultivate a vibrant and diverse innovation community through large-scale business meetings.
Eyecelerator is interested in “high-value innovation,” Dr. Kliman said, explaining that this is innovation with big public health benefits that are disruptive and would dramatically change and raise the standard of care for patients.
He also described the Eyecelerator Hierarchy of Innovation, which is a pyramid that begins with the intention/license as its base, topped by preclinical data, clinical trials, FDA approval and launch, and finally global success.
Digital health in ophthalmology
Ranya Habash, MD, and Dr. Kliman led a conversation about the state and future of digital health in ophthalmology with panelists Hylton Kalvaria, chief business officer at Verana Health, Pam Nesbitt, global healthcare lead at Microsoft, and Euan Thomson, PhD, president of ophthalmic devices and head of the digital business unit at Zeiss Medical Technology. Dr. Kliman said areas of interest gaining steam in digital health include remote diagnostics, remote patient care, and disease management.
“What does this all mean for ophthalmology? We have companies from outside ophthalmology that are doing incredibly well,” Dr. Kliman said.
Dr. Thomson discussed AliveCor as an example of a technology that expanded its approach to become a valuable digital health tool. It began as a medical-grade EKG that works on a mobile device. Dr. Thomson said when he worked for AliveCor, he spent time surveying the cardiologists and patients who bought the system to figure out what they found useful. Physicians, he said, didn’t like it because patients were emailing them “endless EKGs” that the physician then felt responsible to review and interpret. Patients, however, loved it, especially those with arrythmias.
Dr. Thomson said they needed to find a way to continue serving the patients without disrupting medical care from the cardiologists’ perspective. The company developed a model where the patient could buy the EKG interpretation for $1.50 each without involving the physician. From there, the company began to amass data that it used to build an AI algorithm that is now cleared by the FDA and has automated the EKG interpretation.
Ms. Nesbitt said it’s important to think about how you’ll be using the data and who will be using it before you even start bringing the data in. That helps determine the data model. Ms. Nesbitt then highlighted opportunities for health data: 1) It can be used for clinical decision support at the point of care and could provide insights. 2) It can aid in clinical trial matching; about 10% of clinical trials don’t make it to the end due to failure to ID the patient populace needed for the clinical trial. 3) It can play a role in population health where you can look at changes in health over time in certain demographics, allowing for the potential to identify populations at risk for a health issue earlier.
Mr. Kalvaria said one of the goals of Verana Health, which is the AAO’s IRIS Registry partner, is to digitize the protocols for as many trials as possible to produce a highly curated set of data to be used by the investigator to match patients to a trial.
Dr. Habash then asked the panel their opinions on the consumer healthcare model. Dr. Thomson said empowerment of patients and providing patient-centric services at the point of care is the direction things are going. He said patients should own their own data and have access to that data, which they would have to approve others having access to. He said this is a new environment and thinks this concept of the patient as a consumer of healthcare overlaps with the digital health world.
Dr. Habash brought up the topic of interoperability, asking “Why isn’t interoperability actually interoperable?” One reason, Ms. Nesbitt said, is due to proprietary data formats that are not easy to integrate. To get data out of a legacy EHR, for example, and into something else then into another EHR takes many steps, she said, adding that how users input data into EHRs isn’t consistent either.
Dr. Thomson said this is at the heart of Zeiss’ digital strategy as it strives to create a fully integrated and connected environment of its technologies with software applications that streamline the care delivery model. He said this integration is the future of healthcare and will help allow for new forms of analytics. There are also new data opportunities with wearables, data collected from phones, etc.
“There are many forms of data out there that are relevant to healthcare management that we don’t even think of as related to healthcare today,” he said adding, “We’re defining a new environment where all data systems should connect with other health systems.”
Cornea spotlight
A cornea spotlight at the Eyecelerator meeting delved into the topic of whether cornea transplantation will become obsolete. The discussion first focused on keratoconus before shifting to options in development to replace endothelial keratoplasty.
Moderators of the session were Zaina Al-Mohtaseb, MD, and Deepinder Dhaliwal, MD.
Panelists included Bala Ambati, MD, co-founder and president of iVeena, Nazneen Aziz, PhD, chief scientific officer of Avellino Labs, Chuck Hess, vice president and general manager of U.S. surgical of Bausch + Lomb, and Elizabeth Yeu, MD, medical director of Virginia Eye Consultants/Virginia Surgery Center.
Dr. Al-Mohtaseb started the discussion on the topic of keratoconus. The key is that the economic burden is significant, she said, and there is a public health concern due to the rise in lifetime cost of affected patients. Therefore, early diagnosis and treatment is key.
You want to catch keratoconus as early as possible, Dr. Al-Mohtaseb said, particularly before steepening occurs. Treatments include glasses, contact lenses, and intrastromal cornea rings. But nothing was stopping the progression until crosslinking became an option, she said, and corneal transplantation still has a role at this point. Crosslinking was the first treatment that was able to halt progression and help delay corneal transplantation. Corneal transplantation is still very much in the picture, Dr. Al-Mohtaseb said, because we’re still catching some patients later. In addition, 53% of the world population has no access to corneal transplantation. Access generally isn’t a problem in the U.S.
Dr. Aziz discussed AvaGen, the Avellino product, and how genetics are coming into play in keratoconus. You can tell if a patient has a predisposition to the disease before you see any imaging, she said. Currently, AvaGen looks at 75 genes, with 17 of these for corneal dystrophy. Next year, a new AvaGen test will launch that will look at 135 genes.
Dr. Yeu called it a “sigh of relief” to be able to understand the importance of genetic testing with AvaGen. This is another important piece of data in the diagnostic process because it helps physicians know if they need to be treating early or just monitoring patients closely, she said, adding that this can be invaluable for the adolescent children of adults with keratoconus. Currently, the payment burden falls on the patient, but Dr. Yeu finds it “well worth it because it provides this invaluable peace of mind.”
Dr. Ambati’s company, iVeena, is currently developing an eye drop that will deliver copper to the cornea. This would induce pharmacologic crosslinking, he said, and would be the first pharmacologic therapy for keratoconus.
Mr. Hess discussed Bausch + Lomb’s involvement with the cornea as well as the progression of treatments. He noted that penetrating keratoplasty was the standard of care for years. “We’ve seen this progression of technology through the years,” he said, mentioning DALK, DSAEK, DMEK, and now cell therapy. He said his company is starting to think about what technologies to bring in for a disruptive change in the way patients are treated. This means thinking about treatments that can be used in both developed and developing markets, he added.
Later in the session, Brian Levy, OD, CMO of EyeYon Medical, and Greg Kunst, chief executive officer of Aurion Biotech, discussed what will replace endothelial keratoplasty.
Dr. Dhaliwal highlighted the state of the art of endothelial dysfunction. She mentioned DSAEK and DMEK, as well as the newer option of DSO. DSO, she said, allows the surgeon to strip just the central, diseased zone, but one current issue is that the recovery time is longer. However, she thinks DSO will have a place in the future because of its efficacy, patient acceptance, and safety.
Mr. Kunst spoke about Aurion Biotech’s injectable endothelial cells. The corneal endothelial cells are manufactured in vitro, and cells from one donor can produce 100+ cell therapy treatments, he said. Cells can be injected into a blind patient’s eye and within days, the patient’s vision is restored, he added. This is minimally invasive, proven to work, uses natural human endothelial cells, and the inability to get tissue in parts of the world makes it valuable, he said. This cell therapy is a simple injection, Mr. Kunst said, so we think we can treat the full spectrum of patients. The “genius,” he added, was the ability to replicate cells in the lab that don’t naturally replicate themselves, and Aurion is doing this on a large scale.
Dr. Levy shared EyeYon’s approach to treat corneal edema with an artificial endothelial layer, the EndoArt. This is a prosthetic implant that provides a physical barrier to excess fluid ingressing the stroma, reducing corneal edema, and restoring transparency. It’s dome shaped to match the posterior surface and is 6.5 mm in diameter, he said, and is inserted into the anterior chamber through a small incision and unfolded and placed on the posterior corneal surface. Currently, the EndoArt is CE approved and in clinical study with the FDA.
Reimbursement
Leon Herndon, MD, and Thomas Samuelson, MD, moderated a session focusing on reimbursement, specifically related to MIGS, with panelists Jeannette Bankes, president and GM of surgical of Alcon, Frank Burns, MD, a member of the ASCRS Government Relations Committee; Erin Powers, MBA, vice president of global marketing and product strategy of BVI Medical; Nathan Radcliffe, MD, associate clinical professor of ophthalmology at Mount Sinai School of Medicine; and George Williams, MD, senior secretary for advocacy of AAO.
Dr. Herndon spoke about the 2022 CPT codes for the new combination codes for cataract and MIGS, mentioning the RUC process and proposed reimbursement for 66989 (MIGS/complex cataract) and 66991 (MIGS/cataract). In the CY 2022 Medicare Physician Fee Schedule (MPFS) proposed rule released in July 2021, CMS modified the RUC recommendation and put into place its own work RVU values, resulting in a significant reduction in the current reimbursement for the new combination MIGS/cataract procedures. Dr. Herndon said that 66989 would have only been $3 more than the current complex cataract surgery reimbursement rate and the payment for 66991 would have been $34 more than uncomplicated cataract surgery alone.
However, following advocacy and grassroots actions from ophthalmic societies, industry, and physicians, CMS increased its proposed reimbursement values in the CY 2022 MPFS final rule, with the 66989 final reimbursement at $831.55 (up from the initially proposed $729.46) and the 66991 final reimbursement at $663.56 (up from the initially proposed $565.23).
Dr. Burns thinks that one concern is even with this increased valuation of the MIGS procedure, there may be some patients who are more complex that some surgeons will choose not to do a procedure on because of the reimbursement cut. There is a concern that there may be a switch to goniotomy because reimbursement is higher.
Dr. Williams stressed that in terms of reimbursement and valuing the codes, “we’re dealing with a process put in place in 1992.” The concept of the resource-based relative value scale was that historically, the RUC considered time and intensity, with the rationale that intensity should be rewarded. However, he noted that in the last 5–7 years, there has been a shift to be more time-focused. The problem is that every time we generate a new technology and come up with a new code, that has to go through the CPT process and is brought to the RUC, and if it falls in a specific family of codes, that whole family has to be revalued, Dr. Williams said.
Is this an ideal process? Dr. Williams said it clearly is not, but the alternative is to disband the RUC and have no physician input.
From the industry standpoint, Ms. Bankes mentioned the importance of collectively working together. “It took the effort of industry, societies, and physicians to say that wasn’t acceptable,” she said, referencing the community efforts to speak out on these CPT code values.
“Anytime money leaves ophthalmology, it’s a bad thing,” Ms. Powers, adding that the more options available to patients, the better.
Dr. Williams stressed that there has been an effort to reallocate physician funds to primary care. But the problem, he said, is that there is a “fixed pie,” so if they increase payment for one service, that decreases payment for everyone else.
Despite issues with this process, Dr. Burns noted that the RUC process is “what we have to live with.” He stressed that without this, ophthalmologists won’t have a say. “There are other ways, but without physicians at the table, it would be a disaster,” he said.
With this focus on time to complete a procedure, Dr. Radcliffe noted how important it is to accurately note how long it takes for a MIGS procedure. “We sometimes downplay complications,” he said, adding that when trying to draw other surgeons into MIGS, those surgeons performing the procedures perhaps make MIGS sound simple. “Glaucoma is a serious, blinding disease, and MIGS are the safest and best procedures,” he said. “They can be efficient, but we’re still dealing with glaucoma, and complications are inherent to the disease process.” Surgeons can get slowed down with complications, or there may be added time in the clinic, he said. Surgeons may feel guilty talking about how long it takes to do a procedure, but Dr. Radcliffe noted that this is important.
In sharing concluding remarks on whether they thought reimbursement would limit innovation, the panelists had various thoughts.
Ms. Bankes again stressed the importance of working together and the importance of long-term data to help realize what the reimbursement landscape should be.
Dr. Burns mentioned the importance of getting involved in the legislative process by talking about these issues with your legislator.
Dr. Radcliffe mentioned the 5-year data of the Hydrus (Ivantis), which showed that the procedure can prevent trabeculectomy. This shows the big benefits of MIGS, he said. “We can’t allow a system to exist that disincentivizes surgeons from providing treatments that really benefit patients.”
Dr. Williams concluded by saying that “we need to transition to a value-based system.” Though he noted that he’s not sure how to get there, “we need to reward value.”
Focused session on myopia
A session on the topic of myopia gave an overview of established therapies for myopia control and delved into new technology coming into the field.
Michael Repka, MD, described the current myopia prevalence data, noting that it’s reaching 80–90% in some parts of Asia. The prevalence is lower in Europe with data suggesting 35–45%, depending on age group, and in the U.S., Dr. Repka said there is no population-based data on refractive error. Refractive error experts estimate that myopia will increase worldwide over the next 3 decades up to 5 billion people, with the amount of high myopia climbing to 1 billion people.
The goal of myopia control is to slow progression, reduce the number of patients with high myopia, and address those who are at high risk for myopia-related complications, Dr. Repka said.
There is a long history of clinical, off-label use of atropine, glasses, multifocal contact lenses, and orthokeratology (Ortho-K) to stop myopia progression, said Michael Lachman, president of EyeQ Research. Relative efficacy in reducing myopia progression of these therapeutics is varied, he continued, showing data that high-dose atropine is 75% efficacious, low-dose atropine 53%, Ortho-K 45%, soft multifocal contacts 37% (59% if including newer options), and spectacles 14% (47–67% if including newer options). Mr. Lachman detailed several products in the development pipeline or approved outside the U.S. within these categories, also touching on a few digital products, such as apps to support patients and providers with myopia control goals.
Dr. Repka asked about patient adoption, getting parents on board with these newer therapies when they become available. Sean Ianchulev, MD, founder and CEO of Eyenovia, said he’s been surprised at how many parents are already aware of some of these options. What he wants to figure out is how big off-label use of these products is currently.
“I think we need to get a measure of what people already do,” he said.
Dr. Repka said even after products become approved, there is a question of what is the future off-label. Rajesh Rajpal, MD, chief medical officer and global head of clinical and medical affairs of Johnson & Johnson Vision, said this will be a challenge because he thinks some clinicians will want to use a combination of products and some might not be approved for use together or even individually. Wiley Chambers, MD, supervisory medical officer in the FDA’s ophthalmology division, said he thinks that when the FDA finds a product safe, effective, and approves it, he expects patients will want to use that when it’s available.
Later discussion delved into how long children should be on a myopia control therapy. The answer at this point, Dr. Rajpal said, is we don’t know.
Dr. Repka asked whether optometry or ophthalmology will bring these products into practice. Dr. Ianchulev said there is a lot of awareness and activity on the optometric side with regard to myopia control, and it’s a big primary eyecare issue.
“I don’t know how much will stay in pediatric ophthalmology. I think it will stay more in the primary side of eyecare,” he said.
Eyecelerator closes with awards and ‘eyes on the future’
In its closing session, Eyecelerator awarded three companies for their presentations at the meeting, followed by a discussion about the future of ophthalmology and innovation. Aurion Biotech received the award in the category of cornea, Exhaura in the category of glaucoma, and Nanoscope Therapeutics in the category of retina.
Dr. Kliman asked the panel—Jim Mazzo, executive chair of Neurotech Pharmaceuticals, Dr. Dhaliwal, Dr. Samuelson, Allen Ho, MD, and Tom Mitro, president and COO of Aerie Pharmaceuticals—several questions, including what big things were on their mind for 2022.
Mr. Mazzo said myopia is what he would focus on because of the geographic impact it has. Dr. Dhaliwal agreed, noting the huge market and benefit of being able to halt a disease before it gets significant. She also said better options to treat high myopia such as phakic IOLs and presbyopia pharmaceuticals will be big in 2022. Dr. Samuelson agreed and said it’s a luxury in the U.S. that we can focus on presbyopia when other areas of the world have problems with preventable blindness. Within glaucoma, he said it will be interesting to see where standalone MIGS goes. Dr. Ho said he’s excited to see more durable therapies to address retinal issues. He expects there to be disruptive baby steps for AMD as well. Mr. Mitro said biosimilars and the change they could bring to the marketplace is what’s been on his mind.
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