By Patrick Symmonds and Jeni Takasumi of Health Advances
The annual Ophthalmology Technology Summit (OTS) hosted by OCTANe brings together business executives, investors, clinical key opinion leaders, and startups in the ophthalmology hub of Orange County, California. The day-long conference included multiple panels and company pitches to discuss ways of tackling some of the toughest challenges in ophthalmology today.
The conference highlighted a number of trends in ophthalmic care that are becoming increasingly important in practice management and patient care:
- Drug approvals with novel mechanisms: agents in dry eye (Xiidra) and glaucoma (Rhopressa and Vyzulta) with the first new mechanisms in ~20 years, and the first gene therapy approval for RPE65-associated blindness (Luxturna)
- Significant advances in surgical solutions, including corneal inlays, adjustable intraocular lenses (IOLs), and minimally invasive glaucoma surgery (MIGS)
- Technological advancements in big data and advanced analytics, enabling automated diabetic retinopathy diagnosis including an FDA-approved diagnostic that does not require clinician interpretation
- Practice consolidation and a shortage of ophthalmologists to serve the aging population
- “Millennialization” – converting patients into “customers” and shifting care delivery to mobile devices
Innovators, investors, and practitioners are all optimistic about the future of ophthalmic medicine. Based on the conference presentations and various discussions that Health Advances conducted during the conference, we wanted to highlight four important themes likely to impact the ophthalmology landscape moving forward:
 Opportunities for precision medicine in ophthalmology with a broad set of drug and device-based treatment options available
 Large opportunity for novel products to treat presbyopia
 Need for simple, clear, and actionable insights to drive adoption of complex data aggregation and advanced analytics capabilities
 Reimbursement and business model challenges of promising remote diagnostic and monitoring applications
Precision Medicine in Ophthalmology
Although oncology is the leading therapeutic area for precision medicine advancements, the increasing number of novel ophthalmic treatments, better insights into patient segmentation, and enhanced disease monitoring capabilities, are encouraging development of precision medicine approaches within ophthalmology. Glaucoma, dry eye disease, and anti-VEGF-treated retinal conditions have already emerged as promising candidates for precision medicine.
Glaucoma management is ripe for precision medicine to aid clinical decisions between topical drops and miniature drug-delivery devices injected into the eyes. The rise of MIGS devices, as well as new mechanisms for topicals over the past few years, have given ophthalmologists a number of new options by which to manage glaucoma. OTS panelists agreed that, with the growing number of treatment options, it is increasingly difficult to make sound treatment decisions. More research is needed, but there is an opportunity to identify and use both biologic and digital biomarkers to better characterize patients and help direct physicians to specific topical drop mechanisms or MIGS devices that are more likely to yield the best outcomes for an individual patient.
Dry eye disease is another indication that would benefit from personalization. This multi-factorial disease has several subtypes that respond differently to various pharmacological and device-based therapeutic approaches. Again, we have seen a wave of recent innovation bringing new devices and therapeutics that are often effective in specific patient subtypes, however, biomarker testing may or may not be conducted on all patients. A Meibomian gland dysfunction patient is more likely to respond to treatment with LipiFlow, intense pulsed light (IPL), or the newly-launched iLux device that was on display at the conference. For eye drops such as Restasis or Xiidra, which target eye inflammation, there is a need for better understanding of the correlation of treatment responses relative to inflammatory biomarkers, which could be used to direct physicians to specific therapies.
Finally, wet age-related macular degeneration (Wet AMD) and diabetic macular edema (DME) are promising areas for more customized dosing regimens. Dosing with anti-VEGF drugs today is based on a combination of FDA recommended 1-2 month dosing regimens and physician experience. However, one panelist wondered if it would be possible to use remotely-monitored biomarkers to predict when an individual patient needs their next injection, thereby reducing the healthcare burden of these expensive drugs.
Progress in the Management of Presbyopia
Long known as the Holy Grail in ophthalmology, a safe and effective treatment for presbyopia that is an alternative to wearing glasses has long evaded innovators. However, some recent advances are renewing excitement that high-quality treatments may soon become readily available. KOLs discussed the benefits and advantages of the latest generations of lenses and strategies to inform patients about how this latest generation of treatments differs from those used in the past.
Blake Williamson of the Williamson Eye Center highlighted three of many advances in surgical presbyopia care: two solutions for cataract surgery patients and one for mild presbyopes. RxSight’s FDA-approved light adjustable lens now allows IOL optimization after cataract surgery. Perfect Lens’ developmental refractive index shaping technology may go a step further by enabling surgeons to change IOL power post-implantation with potential to add or remove multifocality. Finally, Allotex’s clinical trial-ready allogeneic corneal inlays may be the first non-synthetic option in the market, offering improved biocompatibility.
In addition to devices, at least three promising topicals with differing mechanisms are moving through the pipeline. All three drops aim to offer temporary relief of presbyopia and may soon provide alternatives to reading glasses or lenses. Novartis’ acquisition of Encore provided it with the rights to EV06, which has completed Phase II and is expected to move to Phase III. Presbyopia Therapies’ PRX100 combines aceclidine and tropicamide and demonstrated near vision improvement of 3-7 lines for up to 5 hours without compromising distance vision. Finally, Orasis Pharmaceuticals (a presenter at the conference) recently closed a $13 million Series B financing with the intent to move a combination of pilocarpine and an NSAID forward to a Phase III clinical trial. Advances in the management of presbyopia are exciting and may provide additional revenue to ophthalmology practices in an era of declining reimbursement.
The Need for Clear Insights from Complex Data
At the conference, we were reminded of how eye care has been leading in data collection and advanced analytics, such as machine learning for retinal disease screening. The rise in the availability of data has the potential to dramatically improve patient care, but busy clinicians do not have time to devote to sifting through piles of data trying to figure out how to best manage a patient. A critical concept for those looking to develop new diagnostics or treatment recommendation algorithms is actionability. A concept that resonated with clinicians in one panel was a ‘stop light’ system of red-yellow-green designations to assist with patient triage. Data analytics software and service developers should aim to draw clear and validated insights that can designate patients into either:
Green – No concerning signs or symptoms; clinician can expect a quick check-up
Yellow – One or two concerning data points; clinician will need to conduct a thorough work-up
Red – Significant concerning data points; clinician should refer patient for more advanced care
Providing clinicians with a preliminary triage rating prior to appointments can help establish expectations and increase efficiency.
What’s Holding Back Remote Patient Monitoring?
Industry experts from Zeiss, Alcon, Allergan, Aerie Pharmaceuticals, and JNJ Vision agreed that technology is ready for applications like remote patient monitoring, so why have we not seen broad implementation?
Digitized diagnostics and monitoring tools are established or in-development for a majority of the most prevalent eye diseases. App-based visual acuity tests are the easiest to implement and are potentially valuable to many indications (e.g., Novartis’ FocalView app for clinical trials). Smart phone-based fundus photography tools have also been developed for remote diagnosis of retinal diseases. Similar advances have been made in remote intraocular pressure (IOP) monitoring via handheld devices or implantables.
With an insufficient number of US ophthalmologists available to treat and monitor the growing number of eye care patients, remote monitoring is an attractive way to shift less complex visits away from the office. Aerie Pharmaceutical’s President Tom Mitro suggested such disease monitoring solutions would be particularly attractive for asymptomatic diseases like glaucoma where payers could benefit from fewer IOP monitoring visits. Furthermore, with millennials driving the trend toward convenience and user experience centered around the smartphone, remote monitoring seems like an obvious solution to improve convenience and provide real-time insights to self-manage between visits. Remote diagnostics and monitoring are seen more as a way to triage patients better before arriving at the physician office than as a threat to eye care professionals, and technology is not seen as a barrier to use by the older population (>60 yrs. old) who are most at risk of developing eye diseases.
If physicians and patients are both on-board, payers remain the last major stakeholder to convince. Unfortunately, attractive reimbursement and profitable business models are a common challenge for companies offering digital health solutions. Despite strong interest, remote monitoring companies will have to demonstrate improvements in cost and/or clinical outcomes before payers will be willing to reimburse the technology and/or interpretation of such data.
It was refreshing to see the passion that industry leaders, innovators, and clinicians had for solving some of the most challenging problems in ophthalmology today. Health Advances left the conference armed with the latest thinking and insights in this exciting therapeutic area, and we look forward to sharing these with our clients.
About The Authors
Patrick Symmonds is a Consultant at Health Advances and a member of the firm’s Ophthalmology Practice. He regularly researches the glaucoma and ophthalmology rare disease markets.
Jeni Takasumi is a Consultant at Health Advances and a member of the firm’s Ophthalmology Practice. She regularly researches the market for various retinal diseases.
Health Advances provides growth strategy consulting services to all types of organizations working across a broad range of clinical areas, including organizations participating in the eye care ecospace, and investors in those companies. Our Eye Care Specialty Practice members stay abreast of the emerging data and expert perspectives on emerging technologies and the market dynamics to support developing the most forward-looking insights and implications for our clients.