ascrs2019

ASCRS, day three

Another information-rich day…

…though slightly more frantic. With two medical sessions and a lot of individual meetings lined up (as well as a flight to catch before dinnertime) this was a day of running from one place to another.

MGD session

Diagnostics

  • Dr Bose presented on infrared meibography in MGD and dry eye syndrome. The point of the study was to relate the tear film to meibography results using a grading scale of 0-3 (0, no loss; 1, 1-33% loss; 2, 34-66% loss; 3, 67%+ loss). A higher grade of dropout correlated with poor tear break up time. (We do not, however, know how that correlates with symptoms.)

  • Dr Farhat presented on meibomian gland changes with age as shown in meibography. Their purpose was about how we can diagnose people earlier in order to have better outcomes. They studied 272 patients aged 20-89. There was a very interesting bar chart, more up and down in there than I would have expected. They did not find meibography to be a good screening tool for MGD.

  • Dr Greiner presented on punctocanthal epitheliopathy in MGD. They studied patients with and without symptoms (based on the SPEED questionnaire). PCE staining was much greater than LWE staining in both groups. Bottom line: “PCE is an easily observed marker for MGD” i.e. a simple way to figure out if you have it.

Lipiflow

  • Dr Hurai (UCinci, J&J sponsored study) presented data challenging the notion that atrophied meibomian glands don’t come back. 68% showed visible improvement in gland structures after Lipiflow, and opened the question of what gland loss means - I didn’t quite catch the wording but to the effect that we need to be questioning whether what’s being seen is evidence of a loss of functioning structure or simply a loss of activity (but resurrect-able structure).

  • Dr Tauber presented data that seemed to show Xiidra basically matched Lipiflow’s results in terms of improvement to both clinical signs and symptoms in both inflammatory and obstructive MGD. “Just a pilot study” as he pointed out.

  • Dr Reddy presented 3 year results of Lipiflow (no industry funding). I really enjoyed the way they looked at this, a great reminder of the heterogeneity of MGD and dry eye and the whole sign-symptom thing. They broke patients into four groups - those who had improvement to both signs and symptoms; signs but not symptoms; symptoms but not signs; and neither. A lot of it went by way too fast for me to get the details I wanted, so I’m hoping to circle back to him for more info. I also had a note that he indicated they saw better PRK surgical outcomes when patients had Lipiflow.

  • No-show for another lipiflow presentation, hopefully it was the least interesting one!

  • Dr Matossian presented on the effect of Lipiflow on keratometry prior to cataract surgery. In half of patients, they went from against the rule astigmatism to with the rule astigmatism, the other half the reverse and just one patient (out of 23) unchanged. 16 patients had an increase in the amount of astigmatism. She stated that 40% of the time, her treatment plan would change. These things… sure would matter in a vision surgery.

Miboflo

  • Dr Gomez compared results of 1 lipiflow treatment to 3 miboflo treatments (done 2 weeks apart). The results for both groups were similar; the mibo patients were somewhat happier; but she also showed how the effects of the treatment wore off over time till patient was back to baseline by a year from treatment. However, they also felt that the Miboflo patients may have been doing more at-home maintenance treatment.

  • Dr Gauro presented study data on Miboflo - 46 patients, average age 54, 91% female. They studied OSDI, TBUT, staining and complications. Patients had 3 sessions - at days 0, 15 and 30, for 8-12 minutes, and final evaluatoin on day 90. All numbers improved and there were no side effects. Staining was only mildly improved. They recommend Miboflo for grades 1-2 on meibography but not for grade 3.

IPL

  • Dr Gauro studied the therapeutic effect of IPL alone (without expression). This is an interesting one because a lot of people dismiss IPL as not meaningful claiming that the patients benefit simply from the expression that always accompanies it. So they studied 36 patients (but lost 10 - yikes!). with sessions on E-Eye on days 0, 15 and 45. OSDI was reduced by 83% at 46 days, 60% at 136 days. TBUT, more. Staining, significantly reduced. I found it amusing that during questioning, they were asked why they would study this without the expression, when it’s known that the expression helps.

  • Dr Quesada presented results from 70 patients in El Salvador with evaporative dry eye. They had three treatments (day 0, 14, 30) and were evaluated for 6 months. Patients were average 58yo, 72% female and with moderate to severe dry OSDI scores. Their TBUT went from 4.2 to 14.6 (but that went down after the 6 month point). Tear meniscus doubled, then dropped a bit before the 7 month point. Meibography improved though I didn’t catch the numbers.

Pipeline drugs

  • Dr Tauber presented on a pipeline drug (NOV03) that they feel goes into the glands and unblocks them.

Demodex

Dr Rosenberg presented on prevalence and demographics of demodex. Among the findings, 83% had demodex after pterygium surgery, and only one out of 82 patients who had blepharitis secondary to demodex was being treated adequately. Patients using OTC drops had a lower incidence.

Conversations

I got to meet Vanessa for the first time, though we’ve known each other for a great many years. Vanessa is a journalist who covers a wide range of ophthalmology topics, and we have often connected over the years when she’s reporting on dry eye. So fun to finally have a face to the name!

Then I had the privilege of lunch with David, a Facebook friend experiencing dry eye pain… he picked me up and took me to a fabulous ‘hidden gem’ type Mexican restaurant (the line winding down the road is excellent proof of their popularity!) where I ate far too much and got to here his story and all about the extraordinary paths he has been down in the search for solutions. I never cease to be amazed at the resourcefulness and effort that people manage to put into the search for answers and solutions, and also to be heartened by the extent to which they often turn around and, like David, help others in their journeys.

Exhibit hall

Johnson & Johnson

They had lots of space dedicated to Lipiflow, but nobody there who could talk about over-the-counter products (Blink brand, and Visine brand for that matter since many of those BAK-laced drops have dry eye in their listed indications). Had some good conversations about the role of symptom surveys in assessing how well Lipiflow’s working for patients over time.

Random observation

Sometimes we have no idea, no idea at all of the challenges that come up in manufacturing and prevent products from coming to market the way we want. I think that the opacity of this process certainly works against perceptions more acutely with the larger pharmaceuticals, because their public face (the public information phone lines) is so impersonal, disconnected and corporate.

Oasis

Oasis are the leader in sodium hyaluronate drops… they’ve been going strong for a long time. Looking forward to the preservative-free multi-dose version of Oasis Tears Plus which is due out later this year reportedly. They have having a bit of a shake-up in their lid scrub selections, and are developing some new things which are expected to come out later this year.

There are so many more I met with, but…

Too much stuff, too little time! Moving on to the medical stuff.

Dry eye session

Biological products

SERUM: Dr Yamada presented results of a study on autologous serum where emphasis was placed on patient satisfaction, ascertained through a series of questionnaires. Patients used 30% serum 4-6 times daily for anywhere from one month to three years. SANDE scores dropped from 79.5 to 42.2, i.e. roughly in half, and all other topical medications (both prescription and over the counter) were reduced while they were on serum.

PRP: Dr Melissa Toyos presented on the “Genius PRP System” that they use at the Toyos clinic. She talked about the lack of standardization in protocols for preparing serum drops, and about how we have ‘barely scratched the surface” and how PRP has up to 8x the growth factors as serum. She presented data on 20 patients, however, more than half of them were also getting IPL, so I don’t know how you would decide what’s helping.

AMNIOTIC MEMBRANE in GvHD: Dr Ham Yin presented a case report of a Graft-v-Host Disease patient in a flare-up where they used sutureless amniotic membrane. What was impressive is that the patient ended up having no symptoms at all for two months, and at that point went back on cyclosporine and artificial tears. He also said that in a recent study in mice, they were able to prevent ocular GvHD from developing in the first place.

Cyclosporine

Dr Sheppard presented on CyclASol, a phase 2b/3 study, where the primary endpoints were corneal staining and OSDI symptom score. Both improved, and they also reported that reading speed improved, which was interesting, and tolerance was good (2% or less reporting discomfort on installation). A confirmatory clinical trial is expected to start this year.

Dr Matossian presented on Imprimis’ Klarity-C, a study meant to evaluate efficacy and tolerability of this drug which is a higher dose than Restasis, which as we know has a lot of tolerance issues. Endpoints, again, were staining and OSDI. The trial was for 90 days. Staining and OSDI results were strong, and interestingly, about 1/3 of them actually dropped into a “normal” (i.e. no dry eye) range on OSDI which was impressive.

Pipeline drugs

OC-02: Dr Holland presented results on a Phase 2b trial of Oyster Point’s nasal spray for dry eye (165 patients). I didn’t catch the sign/symptom result details (though symptoms were a visual analog score). Side effects / complaints from the spray were comparable to other nasal sprays. Phase 3 trial should begin this year.

ALG-1007: Dr Donnenfeld presented results from the first human trials of Allegro’s drug, a peptide integrin inhibitor in a hyaluronic acid base. The results for the highest concentration studied showed up quickly and were strong, and it was well tolerated. However, considering the HA vehicle, one of the moderators questioned how they will control for that in the future to make sure the results aren’t attributable to the HA. A second phase 2 trial will be presented this fall at the AAO meeting.

Botox for photophobia?

Dr. Venkateswaran presented data from Anat Galor’s group at Bascom Palmer where they looked at whether Botox would help photophobia and dry eye without migraines (it’s been studied in migraines specifically). it was only six patients and very short but… their light sensitivity improved (although their dry eye clinical signs did not). She talked about trigeminal nerve sensitization.

Lipiflow as a surgical prep?

Dr Vaishnav talked about “20/unhappy” refractive surgery patients. These were very symptomatic patients with high OSDI symptom scores, and they found in confocal microscope examinations that they had “nerve loops”. Those who had high OSDI scores also had a higher percentage of dendritic cells. They did a study where they did lipiflow on evaporative dry eye patients before refractive surgery and measured lots of things about their tears before and after, and felt that Lipiflow “reduced inflammatory and nociceptive factors on the ocular surface, thus reducing the incidence of dry eye and nonciceptive pain post surgery”. Sigh. Can’t we just not do refractive surgery on high risk patients?

Buffering the burning eye drops

Dr Epitropoulos discussed the common problem of patients complaining of discomfort from Restasis and Xiidra. She presented results from a study where they used Rohto “cooling” drops before or after Restasis or Xiidra to see if it improved comfort. I’d love to have seen this compared to any other artificial tear incidentally (what’s special about Rohto?). There were 33 patients and they only included patients who were reporting an irritation from their prescription drop of 4 or higher on a scale of 1-10. She had them use Rohto either 5 minutes before or 5 minutes after the prescription drop. 96% percent experienced improvement. In discussion afterwards, someone questioned why 5 minutes and whether that would affect drug retention time on the eye surface. (Incidentally, even the AAO cites 5 minutes as a safe rule of thumb, but where’s the science?)

Neuropathic pain treatments

Last, three residents in a row reported on pain treatment studies from Bascom Palmer:

  • Gabapentinoids (7 patients): 2 resolved; 3 significant improvement; 1 slight but noticeable improvement; 1 no improvement. Higher doses were more effective.

  • TENS (8 patients): 6 patients used it consistently up to 3x daily for 3 months, then decreased to 3x a week. Pain dropped about in half from 8/10 to 4+/10 (dryness and light sensitivity did not improve, but pain did). 2 patients did not benefit and stopped using.

  • Nerve block: Case report of a successful treatment.

That’s all for now….

There is so much more that happened, so many more conversations and things learned… sadly, there will never be time to write about it all! Anyway, one last great huge THANK YOU to everyone who helped me to this by contributing to my GoFundMe travel fund. I appreciate you!

ASCRS, day two

Exhibit hall

Trends

  • Hypochlorous acid: It’s everywhere. As I’ve been saying, it’s well on its way to becoming the new Omega 3, in terms of ubiquity.

  • Sodium hyaluronate: It’s coming to more drops in the US, which is a good thing.

  • A “complete solution”: Most companies in the dry eye space that are doing anything at all in over-the-counter and/or consumer products is broadening their reach to cover eyelid care plus eye drops. Dry eye treatment used to be “plug & drop”. Now dry eye care is “Drop… plus clean, heat and squeeze, and wash down some Omega Threes while you’re at it”.

  • Plugs: 6 month dissolveables are all the rage, and everybody’s got their own partial occlusion (“flow controller”) style plug now too.

Ocular Therapeutix: Dextenza

This is not a dry eye drug, it’s a slow release tapered dose corticosteroid. It’s designed for post-surgical use. But the reason I’ve been interested in it is the potential to provide a BAK-free steroid treatment alternative for those patients who are allergic to the BAK preservative which is in almost all steroid eye drops, without them having to resort to costly compounded PF steroid drops that their insurance won’t cover.

Random observations about dry eye in the exhibit hall

  • A woman I met with at one company could have been Exhibit A for the Vampire on your Vanity talk.

  • A young man at another company that I happened to stop and chat with told me his eyes feel dry pretty regularly and asked what he should do. How to answer that? My first instinct, of course, was to suggest he see an eye doctor (oh the irony), but lest he end up in the hands of one who gives out cookie cutter treatments without any differential diagnosis, I went ahead and gave him the schpeel about how the most common form of dry eye is the oil glands, and suggested some simple questions to ask them….

  • Several people I spoke with are in my age range (I’m 50) and have an elderly parent with glaucoma or other ongoing eye problems. They were very aware of the level of discomfort it’s causing, but don’t necessarily know anything about some of the contributing factors, such as the glaucoma medications, or the treatment options. And this… is at an eyecare conference.

Kala Pharmaceutical

Some data were presented about Kala’s drug KPI-121 yesterday in the dry eye session. This is a low-dose steroid meant to be used for two weeks for a dry eye episode. (And yes, it is BAK preserved, but also only intended to be used for short courses, so at least it’s relatively short exposure, but important to know if you’re allergic.) In a lot of their presentations and literature, the place they are carving out for these drugs is based on the understanding that dry eye patients have “flares”. They' have another clinical trial ongoing, just measuring symptoms, and it sure sounds like there is strong reason to believe they can have this approved and on the market in 2020.

Escape

Something went wrong with a lens at some point, and I really didn’t want to deal with it there, so I had to head back to the hotel to deal with it and let my eye recover a bit that afternoon….

NuLids

I talked to their folks on the phone quite a bit and I have one of the NuLids devices at home… not that I remember to use it very often. I am very much a fan of the concept though, of a device for home use that is dedicated to keeping the lid margins squeaky clean. It’s pretty easy to use, reasonably comfortable, and not that expensive. People complain about the cost of the replacement tips, but honestly, it’s still an awful lot less than a lot of things people are spending money on for dry eye these days.

Vital Tears

Another drive-by to say hello. No particular news, but if you’re not familiar with Vital Tears, their raison d’etre is making it easy for people to get autologous serum tears. And they definitely deliver on that promise. Check ‘em out.

Random thought

I often think, these days, about the anxiety driving so many dry eye or eye pain patients to churn through everything from information to doctors to treatments, sometimes many at once, always in rapid succession. What will it take, what would it take to help someone in that state to slow down and start being methodical enough to actually help themselves?

LacriVera

The plug wars! It seems like plugs went from vogue to not quite so much to now coming back more, at least based on how the supply chain is proliferating. Anyway, the LacriVera family looks like this:

  • “Permanent” types

    • VeraPlug (baseline version)

    • VeraPlug Flow - their partial occlusion version (reduces but does not eliminate tear flow)

    • FlexFit (complete with 45 day retention pledge)

  • Dissolvable types

    • VeraC7 (collagen 7 to 10 day plug)

    • Vera90 (synthetic 60 to 180 day plug)

    • Vera180 (synthetic absorbable 6 month plug)

Bruder

Bruder were the first to popularize a bead-based microwavable warm compress and they’ve done a good job with it. There are now, of course, a ton of lookalikes on the market, so it’s harder for them to differentiate themselves, although their lovely marketing materials sure try hard to, touting their silver-infused “patented MediBeads” versus silica gel beads or other materials, and better durability and washability. All of that seems like reasonable claims to me, but the “two-pod” design that they sport is something I think could cut either way, with some preferring the one continuous compress.

Bruder have several items now specifically for dry eye:

  • Moist Heat Eye Compress (the classic thing)

  • Hygienic Eyelid Sheets (handy liners, sold in a box of 35 individually wrapped)

  • Cold Therapy Eye Compress (gel pad, gets colder than the other thing)

  • EyeLove Contact Lens Compress (am I the only one that finds this confusing? Is it meant/allowed to be used when you’re wearing contacts?

  • Hygienic Eyelid Solution (hypochlorous acid 0.02%, and they seem to be claiming is the only one that is pure like Avenova, but higher concentration… I’m looking into this)

Lacrimedics

Rats, I thought I got some materials, but I can’t find them now. Anyway, they have new plugs coming out, one classic, one flow controller style.

Random idea percolating

Yesterday, I was talking with the head of an intraocular lens company that had created their own software to reach out and check in on the progress of patients by email for a couple of years after their eye surgery. I really liked the concept of how it worked - and simply the act of reaching back, routinely, to all of them. With my dry eye hat on of course I’m thinking of ways they could flag and reach out to people who are unhappy with their dry eye status afterwards and might otherwise just move on to another provider if they don’t feel they’re getting enough help.

From there, the creative juices got going and… I started pondering, and started noticing all the companies in the exhibit hall whose business centers around managing communications (email, text, etc) between eye care practices and their patients. What if… those constant contact systems incorporated an OSDI dry eye survey, which would serve both to let the patient know the severity level of their dry eye AND alert the physician’s office to patients who really need some dry eye follow-up even if their surgery was otherwise successful? Hm, hm, hm.

So I started poking around and talking to additional companies. I got a lukewarm response from most of them (as I expected) except one. Thanks to a smart staffer who matched us up, I ended up talking to a head of another company who turned out to be at least as much of a data-lover and database-visionary as I am… the difference being, he actually has the technology and has access to something like 24 million patients via several systems united under the same roof, where ideas can actually come to fruition. It was so much fun learning more and drooling and fantasizing over all the software projects that I believe could help people with dry eye. The time will come!

EyeVance

EyeVance recently acquired FreshKote from Focus Laboratories at the same time (if I understand correctly) that it went from conventional to preservative-free multi-dose packaging. FreshKote continues to be a bit of an ‘orphan’ product - which is sad, from my standpoint, as I remember when it was one of four wonderful products, and I just wish the others could some day return to market.

ASCRS, day one

Arrived! (the night before…)

What a great time of the year to be in San Diego! Lovely and mild. I drove down from Claremont Friday night, after attending Aidan’s glee concert at Pomona on Thursday and spending all day Friday in a joint intensive Dry Eye Foundation work session.

I’m staying at a fun little place not far from the convention center, the Horton Grand hotel. All I knew at the time that I booked was that it was the cheapest one on the convention’s list that still had rooms available, but it reminds me a lot of the hotels in Port Townsend out on the Peninsula west of home… old restored buildings.

The very best thing about this hotel though - and some of my old LASIK buddies will surely relate - is the lighting. One of my vision issues is extremely poor contrast sensitivity, as a result of which dim lighting is torture. I dread arriving at hotels late at night when my eyes are at their worst only to have to fumble all over the room to find switches, and even then, with every one of them on, to have a poorly lit room. At the Horton Grand, the moment I walked in the door, I found two light switches which turned on two nice bright overhead lights. HEAVEN. How many hotel rooms have overhead lighting?

In this blog post:

1. Exhibit hall day 1

First day, notes from seven companies related to dry eye

2. Scientific session on beauty and dry eye

All about eyelash enhancements, cosmetics, and other beauty products and procedures and how they affect dry eye.

3. Scientific session on dry eye (scroll way, way down)

Diagnostics, treatments, pipeline drugs and more… lots of study results presented and discussed.

Exhibit hall (May 4)

Random observations

It’s not as big as, say, Vision Expo West, but it’s… pretty large. More than that, though, it’s opulent. That’s my main memory of ASCRS meetings past. It’s all about refractive surgeries, from LASIK to fancy upsells on your cataract surgery lens implants. There is a lot of money kicking around. It makes for some beautiful booths, a decent amount of free food and drink, and nice thick carpeting.

Scope ophthalmics

A lot of the European and Canadian members of our online groups are familiar with Scope as the source of Hylo eye drops, especially Hylo Forte. These are great examples of typical HA drops available almost everywhere in the world except, for the most part, in the US. Hylo drops are deservedly popular and plenty of people buy them in the US from shady Amazon sellers (yes, this is possible, and it is one of the few examples of how Amazon’s UTTER disregard for the FDA may work in consumers’ favor). I stopped by because I wanted to see if Scope have anything new going on and also to get a read on whether there’s any likelihood of trying to expand into the US market.

… We interrupt this broadcast to explain some minutiae about “HA”…

HA = hyaluronic acid. If that sounds scary (acid?), it’s actually not. In fact, it will probably show up on a product label as sodium hyaluronate, which is a much more user-friendly term. Anyhoo. HA is very good for the cornea. Well-made drops with HA (not all are…) tend to be very popular and even the lesser ones are pretty well liked. The problem? HA is not allowed in over-the-counter eye drops in the USA, thanks to the FDA’s antiquated 1970s standards. Except that the Polichinelle’s secret of those selfsame restrictive standards is that you can actually put pretty much anything you want in an eye drop in the US as long as you list it in the “inactive ingredients” list rather than the “active ingredients” list. We used to do this with the Vitamin B12 in NutraTear and Vitamin A in Dakrina, away back in the day before Freshkote. Allergan does this with the oils in Optive Advanced and Mega 3 and now HA in Refresh Repair. Oasis does it with HA in their drops. TheraTears does it with the trehalose in their newest drop (more on that shortly). So you can do anything you want, really, but the hitch is that if you list your beloved ingredient in the inactives, you can’t make “medical claims” for it. That is, you can’t go around advertising it and telling everyone how great and effective this ingredient is, out of one side of your mouth, when out of the other you’re stating on the label that it’s an inactive ingredient.

Ah me, the complexities of working around a thoroughly uncooperative FDA. Cue the violins.

…And now we return to Scope.

No Hylo line to be seen at ASCRS - instead they are touting their new Optase brand. This new brand follows the now thoroughly predictable “family” of products that is de rigueur for any small eye drop manufacturer: make it a family - take care of the lids. So they are sporting a conventional microwavable compress plus a conventional tea tree lid wipe with HA. But they also have some interesting lubricants including a preservative-free dry eye spray which is expected to come to the US market some time later this year, and a new HA preservative-free drop in development. It’s funny, sprays never really took off in the US but I think they’re a pretty interesting way to deliver some moisture.

Rayner (Drops in Europe)

Rayner is a UK-based intraocular lens manufacturer but they caught my eye because they have some brand new HA preservative-free drops (Aeon brand). They are marketing them specifically for post-surgical use, but I understand they are also available on the UK Amazon site. If you’re in the UK, look ‘em up.

Allergan (Drops and ointment)

Refresh PM, everyone’s heartthrob ointment (for those who actually like ointments) is still on the same timeline as I was told last November, which is reassuring - they fully expect it to be in stores on schedule later this year.

Refresh Repair (Allergan’s newest dry eye drop) is coming out in a version labeled for contacts, which is great! Better, though, is that it’s coming out in a preservative free multi-dose eye drop which is expected in stores this summer. Will they ever cross the two and make the contact lens version preservative-free? Possibly. There are no PF contact lens drops on the US market and I imagine if anyone crosses that line, it will be Allergan.

Preservative-free multi-dose packaging, by the way, is definitely the trend to watch in eye drops. This is a good thing, because we want preservative-free, and bottles are more economical than vials. The downside is that the bottles are more difficult to learn to use… there is definitely a learning curve.

Once we actually have some of Allergan’s new bottle, I’ll be doing a YouTube video with all the preservative-free bottles on the market and how they work.

Random observation

There are an awful lot more suits at ASCRS than there were at ARVO. Just a part of the completely different atmosphere.

Digital Heat Corp (Heat treatment)

This is one of the companies I’ve been interested in because of their “warm compress” device. They have a version for use in-office and a version for home use. They’re expensive, but interesting. It’s a wearable powered device, and limits the heat to just the areas that need them. I’m going to get a sample to try out.

Akorn (TheraTears, drops and lid stuff)

The TheraTears product line has one recent and one brand new addition:

  • Theratears EXTRA, with trehalose, a new eye drop. I’m still waiting for them to get back to me on the trehalose concentration.

  • TheraTears Sterilid Antimicrobial, a hypochlorous acid (0.01%) spray for lids… yes, they’ve jumped on the same bandwagon as everyone else. But I love that they have the concentration of every ingredient on the their list… who does that?

Avenova

Avenova is the classic name brand prescription hypochlorous acid lid cleansing product. It’s an interesting-looking world now that there are so many over-the-counter hypochlorous acid alternatives (I came across, let’s see, I think at least three more new copycats here at ASCRS).

Sun Ophthalmics

Sun is the maker of CEQUA, the new cyclosporine eye drop, and the big question is when is it coming and how much will it cost! Timing looks like July, and it sounds as though they are sensitive to the high cost issues of Restasis and fully intending to make CEQUA more accessible.

Bausch & Lomb

Despite an awful lot of floor space, sponsored areas etc, they had no staff at ASCRS for any over-the-counter products, which surprised me. But from what I could find out it doesn’t sound like they have anything new in the works for their OTC product line, either. I asked about potential for a preservative-free Lumify and that is not sounding likely. None of this is surprising from the company that still puts BAK in two of their artificial tears! Bausch, we’d like to see you start paying attention to the needs of the dry eye world.

Sessions (May 4)

Vampire on the Vanity

This was the killer session! I wish everyone could have been there! Now I am stuck trying to interpret my very messy hand-written notes from a week and a half ago. Hate it when I do that. If any of the presenters happen across this I hope they’ll forgive-and-correct any particularly egregious misquotes.

1. Eyelash enhancements, tattooing, and more.

Dr Matossian started us off with an exhaustive talk on quite possibly every potentially harmful eye-enhancing beauty procedure that’s ever been proudly sported anywhere from a nightclub to the Met Gala, from all forms of eyelash extensions to some quite shocking examples of jewelry implants.

Some of my general take-homes:

  • People get trapped into progressively more harmful eyelash-enhancing products and procedures. They become intolerant of one and move on to the next, in a harmful, addictive vicious cycle.

  • Where you get a procedure done really matters. If you’re going to do it at all, go to someone who does it in an eye doctor’s office and has proper certifications. Beauty parlors… not so much.

  • The length and curvature of our eyelashes is actually determined by nature for optimal protection of our eyes. Longer lashes make ocular surface disease worse! Changing your lashes can actually create a “wind tunnel” that directs particulate matter right into your eyes! (Dr Periman also mentioned how the lid-lash ratio is important.)

  • People commonly fail to clean their lashes and lids when using eyelash enhancements of various kinds, because of the cost of redoing or repurchasing them, and this leads to lots of problems.

  • Watch out for the formaldehydes (among other things)

On eyelash extensions:

  • If done incorrectly, they damage the natural lashes.

  • If you have latex allergy, watch out! One of the unsuspected sources of latex may be gel pads used in the procedure.

  • They are addictive. People don’t want to wash them, because they are expensive to get redone, so debris accumulates leading to blepharitis. The debris in term breaks down the bonds and then you get them done even more frequently.

  • Lash extension cleaners are also toxic (of course).

  • (I can’t remember if this was Dr Matossian or someone during the Q&A, but someone mentioned that they always tell Lipiflow patients to stop getting extensions.)

  • Dr Periman mentioned later how blepharitis patients will often stop lid scrubs after extensions, and so their bleph gets worse.

On false eyelashes:

  • Too much glue is a big problem. (Remember, formaldehyde in the glues.)

  • They are applied 1-2mm above the lash line… exactly where baby lash grown is happening.

  • If you don’t remove them every night, you end up stripping off the new lashes.

On eyelash embellishments

I’m sure some of you saw the pictures from the Met Gala! So here is a little food for thought about what happens when you basically wire stuff onto your lashes:

  • Trauma to the lash and its roots

  • The weight leads to lash baldness

  • Some patients get allergic conjunctivitis from feathers

On LED eyelashes

Two problems - traction allopecia and the glue stripping off new growth.

On mascara

We got to see some beautifully horrific pictures of mascara buildup that actually eroded through to the conjunctiva. Yikes! Takehome: Always remove your mascara.

On lash perming, lifting and tinting

  • Lifting: Potential for chemical burns on eye surface.

  • Tinting: Vegetable based dyes are the least damaging. Tinting is often applied by people who are hair techs not eyelid specialists. Dyes must be tested on skin first in case of reactions. Patient must be upright while it’s done.

On eyelid tattoos

  • Microneedling… if too deep, it damages the meibomian glands and can lead to atrophy. Saw pictures of scary complications that would not heal.

  • Very common in Asia, and very high meibomian gland dropout rates observed.

  • Dr Periman in her later presentation mentioned a case where a tattoo salon blamed the patient. The tattoo inks even at reputable salons have lead, chromium, nickel. These things can permanently damage the MG ‘achitecture’.

On toluene allergy

  • Off-gassing from nail polish is a problem!

  • Even men with chronic blepharitis have had this traced back to their wives’ nails!

  • It doesn’t show for 3-5 days after a manicure

  • Patients get periocular hyperemia and no one connects the dots!

On jewelry implants

Ugh! You just can’t unsee these kinds of pictures:

  • Jewel implants in the white of the eye - that then caused problems

  • Glitter implanted deliberately UNDER the corneal flap created during LASIK

  • Jewel implant in the CORNEA (!)

  • An earring placed by piercing the edge of the eyelid, and which rubbed against the cornea (done in a piercing parlor)

On eye whitening procedures

I am deliberately refraining from even NAMING the whitening procedure that was mentioned at this point - and which goes under at least two different names as I just saw from the website of the physician in question (apparently it’s been re-branded, no surprises there). Why? Simply because I once had a very nasty threatening letter from a lawyer who was engaged in the process of cleansing the internet of any and all references to the AAO’s warning letter about a particular procedure offered by a particular physician (the letter was later retracted, presumably under legal pressure as well). It seems someone once posted a copy of the AAO’s letter on one of my online forums about this, and they wanted all the evidence gone once it had been retracted.

But anyway, Dr Matossian listed a number of the scarier complications associated with an eye whitening procedure, including limbal stem cell complications, infectious scleritis and scleral necrosis. Sigh. It is to be assumed that the patients experiencing those things may not have the beautiful bright white eyes today that they were hoping for, glamorous zip codes notwithstanding.

On scleral tattooing

In scleral tattooing, color is placed in the subconjunctival space. This is done by a tattoo artist who knows nothing about eye anatomy. Not surprising that it may cause issues.

DEEP BREATH!

Dr. Periman (dryeyemaster.com) on cosmetics

So now we have a problem, because at this point things sped up to about 500 mph and I simply couldn’t keep up. My notes aren’t making a ton of sense to me anymore. I probably could have taken some pictures, but at ARVO they drilled into us so incessantly that photography was verboten, that I was afraid to even appear to be aiming my phone at anything. Moving right along, it is clear to me that (1) there is a ton I need to learn about cosmetics and dry eye because hey, while I personally use almost nothing of any kind on my face, that’s not normal - these are issues that affect most women and many men - and (2) The Dry Eye Zone needs to start creating some very simple, very user-friendly resources to help people navigate information about this. Pondering how to make that happen.

Anyway, unfortunately all I can share from this part of the session are some random take-homes extracted gingerly from my scattered notes:

  • It’s not about the brand. Formulations can change at any time. You need to know about ingredients.

  • There’s an infographic that was very helpful… note to self to ask Dr Periman for it.

  • 85% of eye doctors NEVER ask about the use of cosmetics! HOW CRAZY IS THAT? Imagine the patient she discussed who came in and said “Nothing helps my dry eye!” but whose history included the following, every one of which have potential dry eye implications:

    • Brow lift

    • Abnormal lash length

    • Lash growth serum

    • Waterproof mascara

    • Harsh removers

    • Retin-A

    • Neurotoxin

    • Tatooed eyeliner

  • THE CONUNDRUM: Patients who do not remove makeup have higher dry eye symptom scores (SPEED score, specifically) but… eye makeup removers may be toxic too!

  • “Prost” ingredients eg prostaglandins bad for MGs

    • Active ingredient in lash growth serums.

    • Mentioned a particular one that advertises as prostaglandin-free but wasn’t. It was a >$100 product, not a suspicious cheap knockoff.

  • Parabens… bad for MGs and ocular surface

  • Long tables of ingredients to avoid… need to get this. Included acrylamides, alcohols, retinyls, parabens and preservatives suchas BAK, EDTA, phenoxyethanol, MIT

  • “Hypoallergenic” does not mean safe for the ocular surface.

  • “Ophthalmologist tested” really means nothing at all.

  • “Vegan, gluten-free” etc is not even remotely relevant so why advertise eye care products that way?

  • “Gems” or crushed minerals in cosmetics - what that really means is SHARDS, which can get under your lids and cause harm, but doctors cannot see them without infrared.

  • Good resource: detoxmarket.com

  • A key reason we’re in this mess, and why you might want to buy all your cosmetics while traveling abroad? The US has only 11 outlawed ingredients. Europe has 1300.

Dr Shah on botox and fillers

I didn’t get detailed notes on this one at all. I remember that initially we got a great anatomy lesson about the various eye muscles, then information on all the things Botox affects and how, from the goblet cells to the lacrimal accessory glands to the lacrimal glands to the meibomian glands, and how it can cause lid retraction, reduce meibomian gland expression, and affect basal and reflex tearing and mucin production. On the other hand, it’s used for medical treatments. Random highlights… common treatment for benign essential blepharospasm. There was a study that compared Botox to plugs! And it’s been used as a “protective ptosis” or temporary tarsorrhaphy. Another study showed post LASIK patients were happier after botox. Eventually, my eyes crossed and since I think all the Botox stuff is covered pretty well in TFOS DEWS II, I took a break and just listened.

Final take-home though - which I’ve heard often before - where they place a Botox injection is everything. I get a lot of calls from people with poor outcomes so I’m a bit sensitized to this.

On fillers, she discussed among other things hyaluronic acid gel filler for lower lid retraction. For some patients, this may be better than surgery. My takehome again was that skill matters. She presented a horrific case of a poor outcome where the injection was every so slightly off.

Dry Eye

I love the wide range of things that get studied about dry eye these days. Here are some highlights from a Saturday afternoon session on dry eye:

  • A new tear film imager from Israel (Tear Film Imager, AdOM, no regulatory approvals yet) was presented that shows all kinds of fascinating things about tear film composition and dynamics, from tear break-up, to lipid layer thickness, and from their website it sounds like they’re studying more than that as well. I love these advancing technologies… only, they’re just not likely to make it into mainstream practices. I think of all the people who could benefit from non-invasive dry eye testing.

  • Speaking of invasive dry eye testing, we saw data comparing non-invasive versus invasive TBUT testing. (Since fluorescein can destabilize the tear film, TFOS DEWS II recommends the non-invasive version of this test.) It seems fluorescein TBUT tends to be lower than the non-invasive counterpart.

  • From my neck of the woods (Seattle area), Dr Periman presented on increases in MMP9 levels (this is an indicator of inflammation) as the air quality index goes down during forest fire season.

  • Ever think about how fasting affects the tear film? With fasting for health benefits on the rise, Dr Brian Armstrong was interested enough to study the tear film during Ramadan fasting. Patients ranged in age from 23-45 (i.e. young!) and the number with positive scores on Inflammadry testing doubled during Ramadan.

  • Dr Karakus from Wilmer eye (Johns Hopkins) presented data indicating that Sjogrens patients have a higher rate of depression than non-Sjogrens dry eye patients who have a similar severity of dry eye.

  • Dr Patel presented on corneal nerve morphology and mentioned that editorial about pain (to what extent dry eye versus nerve pain) by Anat Galor that’s still sitting on my desk waiting for me to sit down with it….

  • Dr Karakus presented results of a study on the effects of prolonged reading on tear film homeostasis. An interesting point was that osmolarity decreased immediately after reading.

  • Then there were two presentations on the DREAM study. DREAM was a massively large, NIH-funded year-long very sophisticated study of the effect of Omega 3 - specifically, fish oil - on dry eye. Since it was such a large study, people will be continuing to crunch its numbers in various ways forever.

    • The first of these presenters went over the basic results, which stunned everyone last year by showing omega 3 had no more effect on dry eye than the olive oil placebo, and a couple other points like showing that omega 3 levels were not associated with dry eye symptom severity.

    • The second one noticed two interesting things about the dry eye signs vs symptoms issue: 1) Those with severe symptoms had a higher level of “discordance” between signs and symptoms - that is, it was harder to draw a line between how their eyes test and how they feel; also 2) The younger you are, the more likely there is to be a mismatch between signs and symptoms.

  • Dr Vendal presented on dry eye as a huge problem for glaucoma patients taking topical glaucoma medications. They studied 8 patients treated with Prokera, the amniotic membrane treatment, who did well. No mention, however, of which glaucoma medications or whether they were BAK preserved.

  • Then there was a fascinating presentation by Dr Zadok on ocular magnetic neurostimulation treatment for dry eye. They treated 1 eye of 9 patients, and found that it reduced staining as well as symptom scores, and patients used fewer artificial tears. They specifically mentioned a 40+yo male with Sjogrens syndrome who had had LASIK (zowie, what an awful combination) and the positive results they had.

  • Dr Holland presented current clinical results on pipeline drug KPI-121, a nanoparticle loteprednol - basically a two week low dose steroid treatment specifically for dry eye “flares”. They have a third Phase 3 trial ongoing.

  • Next up was TrueTear, the intranasal neurostimulator from Allergan. Dr Passi confirmed the results they were seeing indicated the effect is all on aqueous, not meibomian, secretion, and effects were felt up to 8 weeks after ending treatment. There were some interesting questions afterwards about the possibility of treating one side but seeing results in both sides.

  • Last presentation was about crosslinked amniotic membrane as a dressing for ocular surface disease. We’re certainly seeing more and more uses of AM in dry eye.

Dry eye at ASCRS... condensed version.

In a nutshell, of sorts….

You know it won’t be brief, because I never am. But also, bear in mind that ASCRS is about cataract and refractive surgery, beginning to end - neither of which I care about in the least… except of course as they relate to dry eye.

Following are some of my personal take-homes: highlights and impressions from the three days I spent at this very enjoyable event, partly in presentations but even more in the exhibit hall talking with companies there.

When I was at ARVO (a similarly huge but awesomely, intensively research-focused event) the previous weekend, I blogged every day. I never blogged once from ASCRS. It was partly that my days were so crammed that there was no time to spare, and partly that by the time I was one day in, my eyes were in such a state from flying and hotels and ‘convention center air’ that blogging into the wee hours was simply not an option. I arrived home after midnight Monday with stacks and stacks of notes, but also a week’s worth of work waiting for me. I figured I would start with the nutshell version first, in case I never get any further!

We need to talk beauty.

Vampire on the Vanity was the best kept secret at this conference.

“Vampire on the Vanity: Ingredients and Habits that Impact Dry Eye Disease”, by Drs Matossian, Periman and Shah was a phenomenal session. Honestly, every eye doctor treating dry eye needs to know the information they presented. I am hoping to make time this week for a blog post devoted entirely to that session so that I can get into more detail. But here are some quick highlights of the types of material they covered:

  • How your eyelashes work, what they’re there for, why that matters, and why messing with them can be a problem.

  • How lashes the wrong length or shape create a ‘wind tunnel’ directing particulate matter onto your eyes!

  • Exactly what each popular eyelash enhancement procedure does to your lashes and why you should care.

  • Everything you really, really, really did not want to know about the American cosmetic industry and what it is doing to our eyes.

    • Did you know, for example, that while Europe has banned 1300 different toxic ingredients from cosmetics, the FDA has banned (drumroll) 11?

    • Did you know that if the cosmetic product contains less than 1% concentration of an ingredient, they’re not required to disclose it at all, so you have no way to even find out what the worst possible ingredients are?

  • All about a vast array of cringeworthy eye embellishments from tattooing to jewelry implants in all kinds of surprising places to decorative items you never would have imagined, and the predictable and unpredictable damage they can cause.

  • And then a whole lot about Botox. I’ll save it for the separate blog post.

Goings-on in the MGD world

Heat & squeeze is going strong

Tons of exhibit floor space dedicated to Lipiflow, and a respectable amount for iLux, but also a noticeable presence both here and in scientific sessions from MiboFlo. In terms of heat only, there’s TearCare with their wearable thingy, and the Digital Heat Corp who have both an in-office and at-home device.

Scurf-scrubbing is holding steady

In terms of cleansing only, there was Blephex of course, and also NuLids, for whom I can’t help feeling some fondness simply because with out-of-pocket dry eye care costs skyrocketing, I want to see more compliance-friendly at-home care devices on the market rather than more and more expensive in-office procedures which are proliferating largely because we patients have amply proven that we really will pay anything for relief.

Oh, and everyone and their dog is now making or selling one of these:

A hypochlorous acid lid cleanser, a/k/a the Avenova knockoffs.

Yes, hypochlorous is the new Omega 3, that is, the newest de rigeur complement to the portfolio of any self-respecting dry eye product maker. I saw or heard tell of at least five new brand name hypochlorous acid lid ‘scrubs’ in the ASCRS exhibit hall, either just launched or coming soon, among them, TheraTears and Bruder. That’s on top of many others already on the market. I have no doubt optometrists will be private labeling them left and right before long, if they aren’t already.

Sometime soon, I need to get one of my learned friends that does not have a financial interest in any of them to explain to me for the third time, in words of as few syllables as possible, what it is that makes one hypochlorous acid product “pure” and the others “bleach-like”. But the very fact that I, who have at least a mild passing interest and one or two surviving brain cells despite my chemistry illiteracy, can’t seem to retain these facts long enough to explain them to the next person, tells me that Avenova lost that battle some time ago. I think far too many people are ignorantly happy or happily ignorant with the now ubiquitous over-the-counter versions to slow down the Avenova market share erosion.

And the MGD debates are raging

It’s not just Lipiflow, Lipiflow, Lipiflow. It’s Lipiflow vs Miboflo, Lipiflow vs Xiidra, and where is IPL in the midst exactly? The Meibomian Gland Dysfunction session on Monday was packed with study data presented on Lipiflow, Miboflo and IPL and was so interesting. I’m blogging on that separately in a bit, but a few highlights here:

  • A study claimed to show that glands really are resurrect-able with LIpiflow.

  • Another “pilot” study claimed Xiidra basically matched Lipiflow’s results in terms of improvement to both clinical signs and symptoms of dry eye.

  • 3-year results of lipiflow were presented.

  • At least three presentations remarked on improvements in cataract or refractive surgery outcomes when lipiflow is done prior to surgery.

  • 1 lipiflow was pitted against 3 miboflos 2 weeks apart, with similar results.

  • A pipeline drug is claimed to be able to clear blocked glands.

  • A miboflo study showed decent results at 90 days.

  • An IPL study examined how IPL does if you DON’T do expression (note: everyone does expression after IPL, so this was particularly interesting)

  • And another IPL study looked at 6 month results

  • Posting more details on all of these tomorrow (hopefully)

Intraductal probing felt rather conspicuously absent, but then, I don’t really know how much there has been about this at past meetings.

Don’t forget the Demodex

Dr Rosenberg presented on Demodex and the numbers were quite interesting. Most memorable: “only 1 of 82 patients with blepharitis secondary to demodex was being treated adequately”. The focus of their study was pterygium surgery patients, 83% of whom had demodex (!!).

Oh, and about the Omega 3s…

Seems like… DREAM hasn’t put a dent in anyone’s confidence in Omega 3s?

I find that so interesting.

As far as I can tell, DREAM was far and away the longest, largest, most sophisticated study ever conducted of the efficacy of fish oil for dry eye, and its conclusion was that it was no better than an olive oil placebo.

When DREAM was published, there was a brief, stunned silence, followed by a flurry of Buts and a mild storm of allegations and criticisms. Then it seems to me everyone just moved on and more or less ignored it. I taste-tested the responses from various Omega 3 purveyors in the exhibit hall and none of them ever lost their stride at all. It seems that DREAM is largely being dismissed as irrelevant. The belief that Omega 3s help dry eye is way too deeply entrenched with both patients and doctors. But I do find it interesting that DREAM hasn’t had more impact. There were two presentations about it on Saturday, but it just doesn’t seem like there is a lot of engagement. Am I missing something? Are there storms raging somewhere that I just didn’t notice? Or do we really not care?

And how about the dry eye sessions?

Random observations….

  • Tear Film Imager from Israel measures a lot of things non-invasively, including mucous layer

  • In a study of depression and dry eye, depression was a bigger problem in Sjogrens than non Sjogrens dry eye

  • A little bit about TrueTear (it would have been nice to see more than one presentation on this) - Dr Passi presented results showing benefits up to 8 weeks after use. Benefits were to aqueous production, not meibomian.

  • 30% autologous serum study that focused on patient experience: SANDE dry eye symptom scores dropped almost in half, AND all other topical medications (both prescription and over-the-counter) were decreased while using serum.

  • Klarity-C (cyclosporine 0.1% in chondroitin sulfate) - 75-patient study with endpoints of staining and OSDI - one-third of patients moved into the “normal” range of OSDI which is really pretty impressive

  • GvHD: Case report about use of amniotic membrane; patient had no symptoms for two months (wow!) then went on cyclosporine and tears, and in a recent mouse study they were able to prevent occurrence of chronic GvHD (a theme I remember from ARVO, they are trying really hard to get ahead of this and prevent acute from turning chronic by catching it earlier).

  • Presentation from Melissa Toyos on PRP drops

  • Bascom Palmer resident presenting on Botox and light sensitivity

  • Dr Donnenfeld presented results from ALG-1007. Seemed to do a great job on TBUT and staining, but questions were raised about separating the effects of the drug from the hyaluronic acid vehicle (echoes of Restasis and Endura, do you remember the days?)

  • A Rohto drop to improve the Restasis experience? Dr Epitropoulos presented results on how much better Restasis and Xiidra patients feel if they take this drop before or after. Would have been helpful to compare Rohto to some other drop, since people really do use a wide variety (at least those that know this trick to reducing the Restasis burn factor).

Corneal pain came in for a lot of attention

…even here in the LASIK mecca (10 years ago who woulda thunk)

Saturday’s dry eye session included some interesting stuff including:

  • a presentation on corneal nerve morphology and how differences in the sub nasal nerve plexus relate to dry eye symptom scores (OSDI)

  • Magnetic neurostimulation treatment

Then on Monday, we got three in a row from Bascom Palmer during the dry eye session:

  • Gabapentinoids

  • TENS

  • Nerve blockers

Pipeline drug updates

  • NOV03 - apparently doing well for evaporative dry eye patients; entering phase 3 trials this year.

  • Dextenza - This is basically a dissolvable plug used for slow release of a steroid (over the course of a month). It’s already approved for post-operative ocular pain, but they’re seeking approval for chronic allergic conjunctivitis. My interest in it is as a way to avoid BAK-preserved topical meds that cause or exacerbate dry eye.

  • OC-02 - Nasal spray for dry eye. Phase 3 trials this year.

  • KPI-121 - nanoparticle loteprednal, a low-dose steroid targeting short term relief for “dry eye flares” - their third study is ongoing

  • CycloASol - Phase Iib/III study went well, starting confirmatory trial in 2019. An interesting result presented was that reading speed improved.

  • ALG-1007, presented some results, more to come at AAO this fall

In terms of new over-the-counter drops…

Not much, but it’s mostly about HA.

Hyaluronic acid, that is. On the label, you’ll probably see it listed as sodium hyaluronate, and it will be listed in the inactive ingredients, but we all know it’s the whole point.

Everyone is either trying to do something with HA, or (for the Europeans) wishing they could somehow squish their already excellent HA products into compliance with the FDA’s antiquated monograph for over-the-counter lubricants so as to tap the lucrative US market.

Oasis, of course, beat everyone to it a long, long time ago and continue to deservedly do extremely well with Oasis Tears and Oasis Tears Plus. Some months hence we’ll be seeing a preservative-free multi-dose version of OTP, which should be very well received, although we consumers are struggling to wrap our brains around multi-dose bottles, which have a distinct learning curve and do not compare favorably to normal bottles.

But Allergan are now working their way in, with Refresh Repair, which although it was launched in a preserved version, will be coming out in preservative-free multi-dose packaging soon as well - an interesting step as it means they are leapfrogging the usual preservative free vials. Others will follow, I’m sure.

Then there’s the trehalose outlier.

TheraTears recently brought out a new drop for the first time in forever, this one with trehalose - another ingredient that Europe brought to market way before the US. Too early to have had much consumer feedback on this one yet.

Did I say something about a nutshell?

This is as brief as I can get for an event I spent three days at. There’s so much more to tell!