The Dry Eye

The state of dry eye care, part 1

This installment focuses on diagnostic testing for dry eye disease.

Back in the Dark Ages, you know, like 1999 or so, dry eye disease was considered the crabgrass that grows on the lawn of eye care. Ophthalmology especially.

My tiny tribe of DED pilgrims were looked upon with pity, if we were looked upon at all. Perfectly good dry eye medications were ignored and/or abandoned, even if they had an on-label indication to treat an established dry eye sign or symptom — ahem, Lotemax (loteprednol etabonate, Bausch + Lomb). The near universal opinion in the eye care community was that there was nothing you could really do to treat DED. Why bother even testing for it when the state-of-the-art diagnostic test was just a gussied-up piece of coffee filter someone named Schirmer filched from the staff kitchen?

How times have changed.

You can tell when a medical disease has hit the big time when there is competition in every part of the marketplace. An especially “hot” segment will also have at least a junior varsity controversy about the accuracy and usefulness of diagnostic tests and a vigorous debate about both the effectiveness and benefit of treatment. We have an abundance of all of that right now in DED. This month, in part 1 of a series, I cover diagnostic testing for DED. Part 2 will cover what is available for treatment.

Let us keep things simple. There are three types of tests available to evaluate DED: tear osmolarity, inflammatory activity and meibomian gland imaging. You can surely come up with other measurements, even some that have an instrument you can buy that will give you some sort of result, but I am declaring that you need only these three.

Tear osmolarity

Measuring tear osmolarity (TO) is now an established part of DED best practices. Period. It is an essential part of both the initial diagnostic process and monitoring the progress of your treatment. Essentially all of the original instruments used to test osmolarity have been relegated to the junk heap of history, and TearLab now has the space to itself. The business model is simple, and anyone who owns a cell phone or uses a traditional razor to shave understands it: The base unit is “free,” and the price of your “lab on a chip” depends on how many you use. Performing the test is simple and fast (less than 30 seconds), and how many units you put in your clinic can be titrated by your flow protocols and your volume.

Inflammatory activity

Some 5 or 6 years ago, Rob Sambursky and RPS developed a method to measure MMP-9 activity on the ocular surface. Above a threshold determined to be highly correlated with DED, a test strip will show varying degrees of pink or red if the test is positive. I am convinced that the results are actionable, as I have written before. A positive test should move you toward anti-inflammatory treatment, and a post-prescription transition from positive to negative is meaningful. The business model is straightforward. There is nothing to buy except the self-contained test strips, and your price per strip is volume dependent.

Again, the test is easy to administer, but it is slow to deliver. In our clinic it takes on average some 15 minutes to determine if we have any reaction. This opens the door to competition, and recent events in Europe show that TearLab is planning on walking through that door. TearLab Discovery recently received a CE mark for a next-generation testing unit that will simultaneously measure TO and inflammatory markers MMP-9 and IL-IR2. Results for all three will be objective, with numeric, absolute levels, and it is predicted that the multiparameter test will take less than 3 minutes to deliver.

TearLab will continue to produce TO-only chips and has plans to continue supporting the testing of TO alone. While I am writing this, TearLab has not announced its business model or pricing for the new-generation instrument or chips. Will the speed, efficiency and convenience of a single platform be the “killer app” making this highly competitive with InflammaDry? We are about to have options.

Meibomian gland imaging

The last leg of our three-legged testing stool is meibomian gland imaging (MGI). There have been, and continue to be, several MGI instruments available on the market. Let us be frank: No one was selling a lick until TearScience got in the game. Once the experienced and highly respected industry veteran Joe Boorady took the reins and reimagined the TearScience business plan, evaluating the meibomian glands took off. LipiView not only images the glands but also provides tear lipid levels and dynamic blink analysis. The smaller footprint, less expensive LipiScan unit can fit in pretty much any pre-exam testing room and provide greater access to MGI.

Competition is on the horizon, though. A small, feisty Southern California company called Meibox is beta testing a unit that can be moved from lane to lane and is less expensive than even the LipiScan. The business plan for both Meibox and TearScience is pretty standard fare for our industry: Buy a diagnostic unit and find a way to bill for using it. Who wins this one? That will depend on Meibox pricing and any other costs to use it, of course. I am going with TearScience wins either way because it has an imaging-dependent treatment to offer (see part 2 next month), and it does not matter what device you use to obtain those images.

To survive and thrive, companies that make diagnostic equipment for the DED community will need to continue to innovate for sure. Ultimately their success rests on a more prosaic and precarious perch: cost and insurance payment coverage for patients. I will finish with a gentle reminder for my friends in this industry. Although I am on record that a best practices DED clinic should include TO, inflammatory activity and MGI, it is your responsibility to make using these tests financially viable for practices and patients.

Remember, we did it without them before.

Disclosure: White reports he is a consultant for Bausch + Lomb, Allergan, Shire and Eyemaginations; is on the speakers board for Bausch + Lomb, Allergan and Shire; and has a financial interest in TearScience.

Back in the Dark Ages, you know, like 1999 or so, dry eye disease was considered the crabgrass that grows on the lawn of eye care. Ophthalmology especially.

My tiny tribe of DED pilgrims were looked upon with pity, if we were looked upon at all. Perfectly good dry eye medications were ignored and/or abandoned, even if they had an on-label indication to treat an established dry eye sign or symptom — ahem, Lotemax (loteprednol etabonate, Bausch + Lomb). The near universal opinion in the eye care community was that there was nothing you could really do to treat DED. Why bother even testing for it when the state-of-the-art diagnostic test was just a gussied-up piece of coffee filter someone named Schirmer filched from the staff kitchen?

How times have changed.

You can tell when a medical disease has hit the big time when there is competition in every part of the marketplace. An especially “hot” segment will also have at least a junior varsity controversy about the accuracy and usefulness of diagnostic tests and a vigorous debate about both the effectiveness and benefit of treatment. We have an abundance of all of that right now in DED. This month, in part 1 of a series, I cover diagnostic testing for DED. Part 2 will cover what is available for treatment.

Let us keep things simple. There are three types of tests available to evaluate DED: tear osmolarity, inflammatory activity and meibomian gland imaging. You can surely come up with other measurements, even some that have an instrument you can buy that will give you some sort of result, but I am declaring that you need only these three.

Tear osmolarity

Measuring tear osmolarity (TO) is now an established part of DED best practices. Period. It is an essential part of both the initial diagnostic process and monitoring the progress of your treatment. Essentially all of the original instruments used to test osmolarity have been relegated to the junk heap of history, and TearLab now has the space to itself. The business model is simple, and anyone who owns a cell phone or uses a traditional razor to shave understands it: The base unit is “free,” and the price of your “lab on a chip” depends on how many you use. Performing the test is simple and fast (less than 30 seconds), and how many units you put in your clinic can be titrated by your flow protocols and your volume.

Inflammatory activity

Some 5 or 6 years ago, Rob Sambursky and RPS developed a method to measure MMP-9 activity on the ocular surface. Above a threshold determined to be highly correlated with DED, a test strip will show varying degrees of pink or red if the test is positive. I am convinced that the results are actionable, as I have written before. A positive test should move you toward anti-inflammatory treatment, and a post-prescription transition from positive to negative is meaningful. The business model is straightforward. There is nothing to buy except the self-contained test strips, and your price per strip is volume dependent.

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Again, the test is easy to administer, but it is slow to deliver. In our clinic it takes on average some 15 minutes to determine if we have any reaction. This opens the door to competition, and recent events in Europe show that TearLab is planning on walking through that door. TearLab Discovery recently received a CE mark for a next-generation testing unit that will simultaneously measure TO and inflammatory markers MMP-9 and IL-IR2. Results for all three will be objective, with numeric, absolute levels, and it is predicted that the multiparameter test will take less than 3 minutes to deliver.

TearLab will continue to produce TO-only chips and has plans to continue supporting the testing of TO alone. While I am writing this, TearLab has not announced its business model or pricing for the new-generation instrument or chips. Will the speed, efficiency and convenience of a single platform be the “killer app” making this highly competitive with InflammaDry? We are about to have options.

Meibomian gland imaging

The last leg of our three-legged testing stool is meibomian gland imaging (MGI). There have been, and continue to be, several MGI instruments available on the market. Let us be frank: No one was selling a lick until TearScience got in the game. Once the experienced and highly respected industry veteran Joe Boorady took the reins and reimagined the TearScience business plan, evaluating the meibomian glands took off. LipiView not only images the glands but also provides tear lipid levels and dynamic blink analysis. The smaller footprint, less expensive LipiScan unit can fit in pretty much any pre-exam testing room and provide greater access to MGI.

Competition is on the horizon, though. A small, feisty Southern California company called Meibox is beta testing a unit that can be moved from lane to lane and is less expensive than even the LipiScan. The business plan for both Meibox and TearScience is pretty standard fare for our industry: Buy a diagnostic unit and find a way to bill for using it. Who wins this one? That will depend on Meibox pricing and any other costs to use it, of course. I am going with TearScience wins either way because it has an imaging-dependent treatment to offer (see part 2 next month), and it does not matter what device you use to obtain those images.

To survive and thrive, companies that make diagnostic equipment for the DED community will need to continue to innovate for sure. Ultimately their success rests on a more prosaic and precarious perch: cost and insurance payment coverage for patients. I will finish with a gentle reminder for my friends in this industry. Although I am on record that a best practices DED clinic should include TO, inflammatory activity and MGI, it is your responsibility to make using these tests financially viable for practices and patients.

Remember, we did it without them before.

Disclosure: White reports he is a consultant for Bausch + Lomb, Allergan, Shire and Eyemaginations; is on the speakers board for Bausch + Lomb, Allergan and Shire; and has a financial interest in TearScience.