Dry eye therapeutic and diagnostic devices are improving treatment
The dry eye market has a proliferation of diagnostic and therapeutic devices that are enabling ophthalmologists to diagnose dry eye disease earlier and provide more therapeutic options.
The prevalence of dry eye disease and meibomian gland atrophy is appearing more frequently in a younger population, according to OSN Cornea/External Disease Board Member Preeya K. Gupta, MD. Gupta and colleagues published a study in Cornea reporting that 42% of pediatric patients between the ages of 4 and 17 years exhibited evidence of meibomian gland atrophy.
“This process is starting earlier, and whether it’s lifestyle, diet or who knows what, even our rising generation is experiencing this. It’s going to be ever prevalent. Every clinician out there should know what’s available, and whether you personally choose to treat these patients or refer them out, you should offer your patients interventions for their disease earlier. It becomes more difficult to treat as time goes on,” Gupta said.
Meibomian gland imaging, or meibography, using either the LipiView or LipiScan systems (Johnson & Johnson Vision), is an important diagnostic point-of-care test that allows the ophthalmologist to see the anatomical structures of the meibomian gland. The imaging shows what is happening at the level of the anatomy of the gland and also gives the user a sense of function and structure, Gupta said.
Even the best clinicians have a hard time identifying meibomian gland atrophy, so procuring high-quality images of the gland can be valuable, according to Gupta.
“Clinically, it’s critical to know how much atrophy is present because it gives you a good sense of the severity of their disease. Somebody with very little atrophy, they’re going to be ‘easier’ to treat or be more successful with treatment. Someone with severe atrophy, it can be a bigger challenge. They’re a challenge to treat, but it helps me to align the patient’s expectations,” she said.
The accurate diagnosis of dry eye disease is essential. Whether a practice focuses on a subspecialty such as retina or glaucoma, or whether it is a primary anterior segment practice, signs and symptoms of dry eye disease are prevalent in today’s lifestyle, OSN Cornea/External Disease Board Member Marjan Farid, MD, said.
Every practice should be equipped to make a proper diagnosis of dry eye disease and be able to categorize the underlying pathology and severity of the condition, she said.
“Although a complete, comprehensive dry eye questionnaire and ophthalmic exam are the foundation for identifying dry eye disease, there are several advances in technology that help add objective evidence to the diagnostic workup,” she said.
Both the LipiView and LipiScan systems give ophthalmologists the ability to make a proper dry eye diagnosis. These systems measure the lipid level in a patient’s tear film and provide a meaningful, real-world point of reference for patients to understand how severe their meibomian gland atrophy may be, OSN Cornea/External Disease Board Member Darrell E. White, MD, said.
A patient viewing a picture of their atrophied meibomian gland and comparing it with a healthy gland can drive home the point that therapy is needed, he said.
“It’s really impactful when a patient looks at a picture of his or her glands and they’re obviously diseased. The takeaway from that is, ‘Holy smoke, I need to do something about this.’ Sometimes the takeaway is no more exciting than using re-esterified fish oil, but it’s incredible how difficult it is to get people to do something when it’s not incredibly extraordinary. Just showing them a picture of their very diseased and damaged meibomian glands is very impactful,” he said.
Both the LipiView and LipiScan systems provide high-quality meibography, but they can be costly to purchase and have a significant footprint. Having a low-profile, in-lane meibography system to capture meibomian gland dysfunction in real exam time can be useful for any practice, Laura M. Periman, MD, said.
The Meibox (Box Medical Solutions) provides an ophthalmologist with a method to capture high-resolution images of the meibomian glands in real time. The Meibox is mounted on a slit lamp and easily integrated into an examination, Periman said.
“Having a variety of options for capturing images is helpful. I love the images from LipiView; however, it is a more technician-dependent procedure that is typically delegated. For a doctor trying to quickly capture something in real time, I think the Meibox is great. I’m impressed with the quality of the meibography images that colleagues post in our dry eye discussion group. Capturing the degree of MGD in real time in the exam lane helps with patient education, understanding and acceptance of the treatment plans that you thoughtfully design. A picture is worth a thousand words,” she said.
In addition to the imaging tools available, point-of-care testing for tear osmolarity and the inflammatory marker MMP-9 plays a significant role in the diagnosis of dry eye disease, OSN Cornea/External Disease Board Member Eric D. Donnenfeld, MD, said.
Currently, InflammaDry (Quidel) is the only in-office test that detects elevated levels of MMP-9, an inflammatory marker that is typically elevated in patients with dry eye disease. The TearLab osmolarity system (TearLab) measures tear film osmolarity, an important factor in patients who may have dry eye disease.
“I think the key to managing dry eye is diagnosing correctly, and for that reason I believe point-of-service testing, such as MMP-9 and osmolarity testing, plays a very significant role,” Donnenfeld said.
Tear osmolarity testing is one of the most important point-of-care tests. The TearLab test provides fast, repeatable, actionable results, White said.
In addition to its current tear osmolarity testing, TearLab submitted a 510(k) application to the FDA in January for the potential clearance of its Discovery platform. The proposed platform will be able to measure the inflammatory MMP-9 biomarker, as well as perform TearLab’s current FDA-approved tear osmolarity test.
“I’m very excited about quantitative MMP-9 testing coming from TearLab in the very near future as well,” Donnenfeld said.
The I-Pen osmolarity system (I-Med Pharma) is a tear osmolarity device currently available in Canada. While not approved in the United States, the FDA issued an acceptance review notification for the system in December 2017.
The hand-held device measures the osmolarity of human tears in normal and dry eye disease patients. The system uses single-use sensors to measure the electrical impedance in the tear-soaked tissues 192 times in less than 5 seconds and calculates tear film osmolarity, according to a company press release.
“The I-Pen is another way to look at or get osmolarity data. It’s available in Canada, and there is a rumor that it’s going to be available in the States. It’s talked about more in the optometric community than it is in the ophthalmic community. It’s always better to have more options. I have no experience with it, but some of my optometric colleagues who I bump into on the speaking circuit have used it and are excited about it,” White said.
With InflammaDry, a tear sample is collected from the patient, and the apparatus conducts a qualitative test of the tear. The test gives a positive or a negative result that indicates if inflammation is present, Gupta said.
“If someone comes in and has a positive MMP-9, I’m more likely to put them on a topical inflammation agent. In the short term, it might be a topical steroid; in the long term, we’re doing more of a medication like Restasis (cyclosporine ophthalmic emulsion 0.05%, Allergan) or Xiidra (lifitegrast ophthalmic solution 5%, Shire). Those, to me, if you see it, you feel obligated to treat it. Clinically, what we see as inflammation might be redness, corneal staining or a breakdown of the ocular surface, but not all patients exhibit those clinical signs, so it’s nice to have a point-of-care test that helps you identify when inflammation is occurring so you can identify it before you have damage to the ocular surface,” Gupta said.
Robust device market
The therapeutic dry eye device market is robust with options for ophthalmologists to select for their armamentarium. Useful items can be as simple as warm compresses for patients to put on their eyes or humidifiers for their work spaces, Periman said.
“I prescribe heated eye masks, and I also prescribe desktop humidifiers to help humidify their immediate environment and slow down the evaporative load of my dry eye patients at work. They both are effective,” she said.
With a confirmed diagnosis of dry eye disease or meibomian gland dysfunction, Farid said the LipiFlow thermal pulsation system (Johnson & Johnson Vision) is a “significantly effective treatment.”
The system uses vectored thermal pulse technology to deliver heat and peristaltic motion to a patient’s eyelid to help remove gland obstruction and stagnant gland content, according to the company website.
“I tell patients to think of the ‘deep cleaning’ of the meibomian glands like they do with their teeth and going to the dentist once a year. It’s very effective,” Farid said.
The LipiFlow treatment heats the gland from the inside, a much more effective treatment than heating the glands from the outside, White noted.
“Then, if you express that melted meibomian gland secretion, you can reboot the meibomian gland function. Just literally getting the gland to open is a big deal. There’s something about the health of the gland — once you do that, the secretions are just of a healthier variety. It doesn’t last if you don’t do the other stuff you’re supposed to do, but it certainly is effective,” White said.
In Clinical Ophthalmology, Kerry Hagen, MD, and colleagues published a study that showed a single 12-minute vectored thermal pulsation procedure with the LipiFlow system resulted in a clinically significant improvement in gland function and reduced dry eye symptoms compared with 3-month use of oral doxycycline.
TrueTear (Allergan), an intranasal tear neurostimulation device, is an exciting tool that “uniquely addresses the neurosensory component” of dry eye disease, Periman said.
The FDA-approved device stimulates a nerve in the nasal cavity and triggers the nasolacrimal reflex pathway, which temporarily increases tear production.
“Patients will notice an improvement in the redness of their eyes, and allergy patients report improvements in their nasal congestion,” Periman said.
It is a “fascinating” device for the dry eye treatment armamentarium. It has a disproportionally large effect on the discomfort that comes with dry eye in comparison with more traditional dry eye treatment, White said.
The device stimulates the production of a completely natural tear, he said.
“But it also seems to relieve more discomfort than you would expect just from the amount of tear production that you get. I think that’s interesting. Because of that, I think TrueTear is probably being underutilized, even by high-volume dry eye clinics like ours,” he said.
At the 2017 American Academy of Ophthalmology annual meeting, Edward J. Holland, MD, reported the results of a prospective, single-arm, open-label study of 97 subjects who used the TrueTear device a minimum of twice a day and up to 10 times per day for up to 180 days. Acute tear production was significantly greater during intranasal stimulation in the True-Tear eye compared with an unstimulated fellow eye at 180 days.
Intense pulsed light (IPL) therapy coupled with meibomian gland expression is also a broad mechanism of action approach for patients with dry eye disease and meibomian gland dysfunction, Periman noted.
“Intense pulsed light is a class II broad-spectrum light device that has an abundance of peer-reviewed literature supporting its use for meibomian gland dysfunction. In my clinic, anytime I see evidence of ocular or facial rosacea related to MGD, I’m offering that therapy. We’ve tracked our patient data and we’ve seen a highly statistically significant improvement in MMP-9 levels. Additionally, a significant number of patients will return to physiologic osmolarity. Our data on osmolarity improvements mirror the findings of Dr. Dell’s paper published in 2017. Patients love the drug-free, drop-free therapy. IPL is my clinical workhorse,” she said.
In a prospective evaluation published in Clinical Ophthalmology, Steven J. Dell, MD, and colleagues evaluated IPL therapy and meibomian gland expression for the treatment of dry eye disease due to meibomian gland dysfunction.
In patients with moderate to severe meibomian gland dysfunction, IPL combined with meibomian gland expression reduced the number and severity of symptoms of dry eye disease. From baseline to final follow-up at 15 weeks, the signs compatible with dry eye disease decreased from 3.3 ± 0.1 to 1.4 ± 0.1, and tear breakup time improved by 93%, Dell reported in the study.
“Treatments like LipiFlow and intense pulsed light therapy have really changed how we address meibomian gland dysfunction. These treatments have a high rate of success. I like to first use meibography to determine how successful a patient might be with respect to these treatments. Someone with a lot of atrophy might not have as much benefit as someone with no atrophy, but I think they really are a game changer in terms of managing these patients,” Gupta said.
BlephEx (BlephEx LLC) for blepharitis is an in-office procedure that eliminates scurf and bacterial debris from a patient’s eyelids. It is a helpful device and technique that “removes biofilm from the lid margin” to alleviate dry eye disease symptoms, Donnenfeld said.
White agreed and said the technique works well, but BlephEx can be challenging because it is “very technique dependent.”
“If you just do it and don’t do it properly, it doesn’t work. If you do it and do it properly, it is an effective adjuvant treatment. It can extend the life of the treatment or the effect of both IPL and LipiFlow. We don’t do it in part because we haven’t really felt adequately trained. That’s partly on us because we as a group, SkyVision, have not been aggressive enough in reaching out to the folks who make BlephEx to be retrained,” White said.
Another interesting option is the iLux device (Tear Film Innovations), which received 510(k) FDA clearance in December 2017. The hand-held device allows ophthalmologists to look at specific sections of the meibomian gland with a magnifier and evaluate their expressibility. The device allows an ophthalmologist to “apply on-the-spot heat and express the gland all in the same go,” Gupta said.
Several companies are also developing and testing new devices for both the diagnostic and therapeutic fields. Sight Sciences, a growth-stage medical device company, is currently evaluating its TearCare system, an in-office therapeutic eyelid technology that delivers a sufficient level of energy to liquefy meibum coupled with gland expression to improve oil flow from the glands. The company initiated the OLYMPIA trial in April to evaluate the safety and efficacy of the system, according to a company press release.
The in-office treatment for meibomian gland dysfunction involves application of external strips to the eye that heat the eyelid. Paired with manual gland expression, it could prove to be an effective treatment, Gupta said.
An optometric device could have an impact on dry eye disease treatment, as a specialized lens could help lessen the symptoms associated with the overuse of digital devices and the “multi-screen lifestyle” patients experience, White said.
Neurolens glasses (eyeBrain Medical) contain specialized lenses to correct the overcompensation of eyes during digital device use, according to a company press release.
“EyeBrain Medical makes a spectacle lens called Neurolens. It is a lens designed to reduce eye movement misalignments, which are felt to be a cause of ocular and head pain syndromes that are associated with eye pain, and specifically associated with the digital vision syndrome or multi-screen lifestyle that I’ve spoken about in the past. The science is new, the device is new, and the lens that it makes is new. In short, there are two holy grails in optical manufacturing: a clear polarized lens, which has not been cracked. There is also a progressive prism where there is more prism in the bottom of the lens than there is at the top of the lens. They have cracked that one, and that’s why it works,” White said.
The device is currently on the market but is more popular in the optometric community, White said. It could, however, be an interesting tool for ophthalmologists to explore for patients who have residual dry eye pain from using a computer or digital device.
“I can’t imagine it won’t bleed over into the ophthalmic community, especially in those practices that have a large dry eye practice,” he said.
With so many dry eye devices already on the market and in production, it may be daunting for ophthalmologists to incorporate new technology into their practice. However, if a practice is already set up to identify patients with dry eye disease, the incorporation of these newer devices should not be difficult, Farid said.
In practices that are still establishing a workflow for dry eye patients, the most important strategy for integration of new technology is to make sure the office staff is involved and educated about the diagnostics and importance of each device, she said.
“The staff can really be invaluable in making sure that the diagnostic workup runs smoothly and all results are ready for the physician when they walk into the room,” she said.
Ophthalmologists should not become overwhelmed with the choices and technology for treating and diagnosing dry eye disease. The future looks bright for streamlining of the technology, but ophthalmologists should not wait to invest in the field, Periman said.
Physicians should pick and choose devices that are right from them and “what is best for your practice,” she said.
“Go from there. Add on from there. There are great professional and clinical satisfaction rewards in having broader diagnostic capabilities and broader therapeutic capacities. Be forward thinking. We’re going to have continuing innovation, but don’t hold off on buying devices now. It’s a great time to get into the technical higher-order care of dry eye disease because as new devices become available new approaches will make more clinical sense and you’ll be able to easily incorporate new technologies into your existing diagnostic and therapeutic framework. Get started, and dovetail in new therapeutics and diagnostics as they become available,” Periman said. – by Robert Linnehan
- Allergan granted marketing authorization by the FDA for TrueTear, the first intranasal neurostimulating device proven to temporarily increase tear production. www.allergan.com/news/news/thomson-reuters/allergan-granted-marketing-authorization-by-the-fd.aspx. Published April 25, 2017. Accessed June 11, 2018.
- Blackie CA, et al. Clin Ophthalmol. 2018;doi:10.2147/OPTH.S153297.
- BlephEx. www.rysurg.com. Accessed July 9, 2018.
- Box Medical Solutions: High resolution meibography imaging. www.boxmedicalsolutions.com/meibox-imaging-solutions.html. Accessed June 11, 2018.
- Dell SJ, et al. Clin Ophthalmol. 2017;doi:10.2147/OPTH.S130706.
- Gupta PK, et al. Cornea. 2018;doi:10.1097/ICO.0000000000001476.
- Hagen KB. Clin Ophthalmol. 2018;doi:10.2147/OPTH.S150433.
- Holland EJ. Intranasal tear neurostimulation for subjects with dry eye disease: Results from 2 pivotal clinical trials. Presented at American Academy of Ophthalmology annual meeting; Nov. 11-14, 2017; New Orleans.
- iLux Device. www.tearfilm.com/ilux-device. Accessed June 7, 2018.
- InflammaDry. www.quidel.com/immunoassays/inflammadry. Accessed June 7, 2018.
- McDonald MB. Meibography improves care of patients with meibomian gland dysfunction. www.healio.com/ophthalmology/cornea-external-disease/news/print/ocular-surgery-news/%7B303004af-fbfd-4a49-bd08-b01697539b0c%7D/meibography-improves-care-of-patients-with-meibomian-gland-dysfunction?page=2. Published March 10, 2018. Accessed June 5, 2018.
- Neurolens. www.neurolenses.com. Accessed June 7, 2018.
- Ocusoft partners with I-Med Pharma to bring the I-Pen osmolarity system to the U.S. www.ocusoft.com/ocusoft-partners-with-i-med-pharma-to-bring-the-i-pen-osmolarity-system-to-the-us. Published Jan. 8, 2018. Accessed June 7, 2018.
- Sight Sciences to study TearCare system for dry eye. www.healio.com/optometry/cornea-external-disease/news/online/%7Bf7e62635-d584-44d1-b6dc-f14ebb3a77f0%7D/sight-sciences-to-study-tearcare-system-for-dry-eye. Published May 11, 2018. Accessed June 6, 2018.
- Sight Sciences initiates U.S. pivotal trial of the TearCare system for the treatment of dry eye disease. https://www.prnewswire.com/news-releases/sight-sciences-initiates-us-pivotal-trial-of-the-tearcare-system-for-the-treatment-of-dry-eye-disease-300638650.html. Published April 29, 2018. Accessed June 7, 2018.
- TearCare system. sightsciences.com/us/products/tear-care. Accessed June 5, 2018.
- Tear Film completes Series B funding. www.healio.com/optometry/business-of-optometry/news/online/%7b9b4d6e51-7b2f-4b84-97d7-ad9f1f0c6d62%7d/tear-film-completes-series-b-funding. Published June 4, 2018. Accessed June 25, 2018.
- TearLab submits 510(k) for U.S. FDA clearance of TearLab Discovery platform. globenewswire.com/news-release/2018/01/04/1283233/0/en/TearLab-Submits-510-k-for-U-S-FDA-Clearance-of-TearLab-Discovery-Platform.html. Published Jan. 4, 2018. Accessed June 25, 2018.
- For more information:
- Eric D. Donnenfeld, MD, can be reached at Ophthalmic Consultants of Long Island, 711 Stewart Ave., Suite 160, Garden City, NY 11530; email: firstname.lastname@example.org.
- Marjan Farid, MD, can be reached at Gavin Herbert Eye Institute at the University of California, Irvine, 850 Health Sciences Road, Irvine, CA 92697; email: email@example.com.
- Preeya K. Gupta, MD, can be reached at Duke University, Department of Ophthalmology, Box 3802, Durham, NC 27710; email: firstname.lastname@example.org.
- Laura M. Periman, MD, can be reached at 1229 Madison, Suite 1250, Seattle, WA 98104; email: email@example.com.
- Darrell E. White, MD, can be reached at SkyVision Centers, 2237 Crocker Road, Suite 100, Westlake, OH 44145; email: firstname.lastname@example.org.
Disclosures: Donnenfeld reports he is consultant for Allergan, Alcon, Kala Pharmaceuticals, Bausch + Lomb and TearLab. Farid reports she is a consultant for Shire, Allergan, Johnson & Johnson Vision, Kala Pharmaceutics, Bio-Tissue and CorneaGen. Gupta reports she is a consultant for Johnson & Johnson, TearLab and Sight Sciences. Periman reports she is a consultant for Allergan, Eyedetec Medical Inc., ScienceBased Health, Shire, Sight Sciences, Sun Ophthalmics, TearLab, Zysant and Umay and is a speaker for Allergan, Bio-Tissue, Eyedetec Medical Inc., Lumenis and Shire. White reports he is a consultant to Allergan, Shire, Sun, Kala, Ocular Science, Rendia, TearLab, Eyevance and Omeros; is a speaker for Shire, Allergan, Omeros and Sun; and has an ownership interest in Ocular Science and Eyevance.
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