The Dry Eye

The dry eye suggestion box

My brother is a very funny man. Our family has vacationed in the same spot on Cape Cod for more than 25 years. We do the same thing on the same day every year, including our evening trips to the local ice cream shop, Sundae School. It, too, sticks to a pretty rigid formula when it comes to its offerings.

Brother: I’d like a hot fudge sundae with black cherry ice cream, whipped cream, nuts and jimmies (sprinkles for you non-East Coast folks).

College kid: I’m sorry, we don’t have jimmies.

Brother: Got a suggestion box?

Like Groundhog Day, ice cream style. Every year. Different kid; same story. No jimmies.

I got to thinking about our dry eye disease world and some of the things I would put into the various suggestion boxes one might find at eye care industry offices or at some of the other major players in the game. Some of the suggestions I have in mind are tiny (like jimmies on a hot fudge sundae) and others a tad more ambitious. In my mind I see a little box, a small stack of 3 × 5 cards and a white Styrofoam cup filled with crayons. I pick up a card, choose a purple crayon (my favorite color*) and scribble my suggestions:

1. We should start with the little things. Here is a suggestion that I would like to put into the box at TearLab and Quidel. Probably need to put a copy in that big old box at the FDA (that no one from the FDA ever opens). How about an objective measure of MMP-9 levels in the tear film? Knowing if there is some activity is better than not knowing, but it has gotten beyond silly trying to determine just how pregnant the tear film is by evaluating the intensity of the red stripe. Having the ability to determine not only the level of activity but the effect of our interventions on activity level would make DED treatment much more objective.

2. ScienceBased Health has a pretty metallic blue suggestion box right inside the entrance to its cafeteria. To the right of the suggestion box is a huge buffet line with all sorts of options straight out of the Paleo Solution. If you look hard, you can just make out a bowl of iceberg lettuce for the vegetarian who works there. That is the only explanation I can come up with for the continued inclusion of 125 mg of fish oil in HydroEye: very few vegan employees at ScienceBased Health. Do you know why it is so hard to treat vegetarians and vegans who have evaporative DED? It is impossible to get them enough omega-3 fatty acid because they will not eat fish oil. In order to get an effective dose of omega-3 from flaxseed, you would need so much you would look like a Chia Pet.

Please make a version of HydroEye without fish oil.

3. Where once we worked under the assumption that most DED requiring treatment was aqueous deficient DED, we now know that the majority of what comes into our clinic is evaporative DED associated with meibomian gland dysfunction. Despite this reality, we do not have a single medication that has an on-label indication for MGD. Heck, I am not sure if using intense pulsed light is actually on label to treat MGD. While we could probably sprinkle 3 × 5 cards in the suggestion boxes of every major pharma player in the eye space, we can save a bit of shoe leather and just make our way to Sun and Akorn. It is well past time for either AzaSite (azithromycin ophthalmic solution) or AzaSite plus steroid to be approved for the treatment of MGD (hat tip Chris Starr).

While I am scribbling in purple, I suggest that one (or both) be nonpreserved so that we do not have to deal with benzalkonium chloride.

4. OK, I guess there is just no way to avoid making at least one suggestion that has to do with paying for something in DED. Here is one for CMS because every payment decision by every third-party payer eventually comes down to whether or not Medicare will pay for a service: Medicare should approve payment for DED tests that will make it worthwhile for DED doctors to do the kind of diagnostic work necessary to make treatment more precise. That means paying for meibomian gland imaging as well as objective testing of tear quality (eg, tear breakup time).

Of course, this means we have to take multiple Ubers to device makers to suggest that they get off the schneid and make us better instruments.

5. While we are standing before the suggestion boxes at places such as Zeiss, Nikon and Olympus, let us put in a suggestion that someone should make us an affordable confocal microscope (hat tip Laura Periman). Really smart folks like Pedram Hamrah at Tufts have been using the confocal microscope as part of their analysis of neurogenic eye pain. It is certainly looking like a decrease in corneal nerves is a consistent finding in these unfortunate patients regardless of the rest of their history. Is there a corneal nerve density threshold below which neurogenic pain is inevitable? Did the patients who went on to develop severe post-LASIK dry eye and pain have a preoperative decrease in corneal nerve density? We do not know because too few patients are being evaluated with this technology.

6. My last suggestion, at least for this trip, goes into the suggestion box in the office of every ophthalmologist or optometrist who does not think that DED is a real thing. Or if it is real, that it is a meaningful problem that deserves the attention (and money) that is being given to it by industry and doctors who treat dry eye. I suggest that you spend a day in the clinic with someone like Mark Milner, Bill Trattler or Ken Beckman, doctors who have been on the forefront of DED care. We would be happy to host you at SkyVision, of course; Cleveland is a hidden gem of a city with something cool for everyone who visits. My treat for burgers at B Spot. Not academic enough for you AAO executive types? How about a bicoastal offering of Dr. Preeya Gupta at Duke or Dr. Marjan Farid at UC Irvine? I am sure that Dr. Galor at Bascom Palmer or Dr. Hamrah at Tufts would be welcoming if you had the courage to sit in on visits with the most profoundly affected DED individuals.

If you visit one of them, I promise we will refrain from a targeted campaign of suggestion box stuffing at university eye programs.

What makes me think that there is any chance whatsoever that any of my suggestions might be followed? Well, let us take a trip back to Cape Cod. It is White Family vacation year 21, and once again my brother is standing at the window ordering his hot fudge sundae with black cherry ice cream, whipped cream and nuts.

College kid: Will that be all?

Brother: Oh, jimmies! I’d like jimmies on my sundae.

Kid: Cool! Do you want rainbow or chocolate?

*Once a Purple Cow, always a Purple Cow. Rather be one than see one.

Disclosure: 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.

My brother is a very funny man. Our family has vacationed in the same spot on Cape Cod for more than 25 years. We do the same thing on the same day every year, including our evening trips to the local ice cream shop, Sundae School. It, too, sticks to a pretty rigid formula when it comes to its offerings.

Brother: I’d like a hot fudge sundae with black cherry ice cream, whipped cream, nuts and jimmies (sprinkles for you non-East Coast folks).

College kid: I’m sorry, we don’t have jimmies.

Brother: Got a suggestion box?

Like Groundhog Day, ice cream style. Every year. Different kid; same story. No jimmies.

I got to thinking about our dry eye disease world and some of the things I would put into the various suggestion boxes one might find at eye care industry offices or at some of the other major players in the game. Some of the suggestions I have in mind are tiny (like jimmies on a hot fudge sundae) and others a tad more ambitious. In my mind I see a little box, a small stack of 3 × 5 cards and a white Styrofoam cup filled with crayons. I pick up a card, choose a purple crayon (my favorite color*) and scribble my suggestions:

1. We should start with the little things. Here is a suggestion that I would like to put into the box at TearLab and Quidel. Probably need to put a copy in that big old box at the FDA (that no one from the FDA ever opens). How about an objective measure of MMP-9 levels in the tear film? Knowing if there is some activity is better than not knowing, but it has gotten beyond silly trying to determine just how pregnant the tear film is by evaluating the intensity of the red stripe. Having the ability to determine not only the level of activity but the effect of our interventions on activity level would make DED treatment much more objective.

2. ScienceBased Health has a pretty metallic blue suggestion box right inside the entrance to its cafeteria. To the right of the suggestion box is a huge buffet line with all sorts of options straight out of the Paleo Solution. If you look hard, you can just make out a bowl of iceberg lettuce for the vegetarian who works there. That is the only explanation I can come up with for the continued inclusion of 125 mg of fish oil in HydroEye: very few vegan employees at ScienceBased Health. Do you know why it is so hard to treat vegetarians and vegans who have evaporative DED? It is impossible to get them enough omega-3 fatty acid because they will not eat fish oil. In order to get an effective dose of omega-3 from flaxseed, you would need so much you would look like a Chia Pet.

PAGE BREAK

Please make a version of HydroEye without fish oil.

3. Where once we worked under the assumption that most DED requiring treatment was aqueous deficient DED, we now know that the majority of what comes into our clinic is evaporative DED associated with meibomian gland dysfunction. Despite this reality, we do not have a single medication that has an on-label indication for MGD. Heck, I am not sure if using intense pulsed light is actually on label to treat MGD. While we could probably sprinkle 3 × 5 cards in the suggestion boxes of every major pharma player in the eye space, we can save a bit of shoe leather and just make our way to Sun and Akorn. It is well past time for either AzaSite (azithromycin ophthalmic solution) or AzaSite plus steroid to be approved for the treatment of MGD (hat tip Chris Starr).

While I am scribbling in purple, I suggest that one (or both) be nonpreserved so that we do not have to deal with benzalkonium chloride.

4. OK, I guess there is just no way to avoid making at least one suggestion that has to do with paying for something in DED. Here is one for CMS because every payment decision by every third-party payer eventually comes down to whether or not Medicare will pay for a service: Medicare should approve payment for DED tests that will make it worthwhile for DED doctors to do the kind of diagnostic work necessary to make treatment more precise. That means paying for meibomian gland imaging as well as objective testing of tear quality (eg, tear breakup time).

Of course, this means we have to take multiple Ubers to device makers to suggest that they get off the schneid and make us better instruments.

5. While we are standing before the suggestion boxes at places such as Zeiss, Nikon and Olympus, let us put in a suggestion that someone should make us an affordable confocal microscope (hat tip Laura Periman). Really smart folks like Pedram Hamrah at Tufts have been using the confocal microscope as part of their analysis of neurogenic eye pain. It is certainly looking like a decrease in corneal nerves is a consistent finding in these unfortunate patients regardless of the rest of their history. Is there a corneal nerve density threshold below which neurogenic pain is inevitable? Did the patients who went on to develop severe post-LASIK dry eye and pain have a preoperative decrease in corneal nerve density? We do not know because too few patients are being evaluated with this technology.

PAGE BREAK

6. My last suggestion, at least for this trip, goes into the suggestion box in the office of every ophthalmologist or optometrist who does not think that DED is a real thing. Or if it is real, that it is a meaningful problem that deserves the attention (and money) that is being given to it by industry and doctors who treat dry eye. I suggest that you spend a day in the clinic with someone like Mark Milner, Bill Trattler or Ken Beckman, doctors who have been on the forefront of DED care. We would be happy to host you at SkyVision, of course; Cleveland is a hidden gem of a city with something cool for everyone who visits. My treat for burgers at B Spot. Not academic enough for you AAO executive types? How about a bicoastal offering of Dr. Preeya Gupta at Duke or Dr. Marjan Farid at UC Irvine? I am sure that Dr. Galor at Bascom Palmer or Dr. Hamrah at Tufts would be welcoming if you had the courage to sit in on visits with the most profoundly affected DED individuals.

If you visit one of them, I promise we will refrain from a targeted campaign of suggestion box stuffing at university eye programs.

What makes me think that there is any chance whatsoever that any of my suggestions might be followed? Well, let us take a trip back to Cape Cod. It is White Family vacation year 21, and once again my brother is standing at the window ordering his hot fudge sundae with black cherry ice cream, whipped cream and nuts.

College kid: Will that be all?

Brother: Oh, jimmies! I’d like jimmies on my sundae.

Kid: Cool! Do you want rainbow or chocolate?

*Once a Purple Cow, always a Purple Cow. Rather be one than see one.

Disclosure: 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.