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