Chapters Transcript Dry Eye Update 2026 Course: Current Concepts of Ophthalmology 2026 And I'm just gonna give you exactly a little of what's up and what's new in dry eye. These are my disclosures and moving on. So for my talk I'm gonna divide it into kind of three sections talking about what was recently approved in the field of dry eye, a few medications, what's hot off the press over the past 6 months, and what's pending FDA approval, and a few other things that I think are interesting molecules, something about regenerative, um, dry eye medications and some new technology. So let's get started. First one up we know about this one perfluorral hexyl octane. I love saying it. It's a 100% inert anhydrous semi-fluorinated alkane. What does it do? How does it help us in dry eye? Well, it interacts with lipophilic component of the tear film to prevent evaporation. It also penetrates deep into the mybomian glands to dissolve those altered thick, the thick mi bum. This drug has been around for 10 years in Europe and just recently approved here in the United States, and a lot of my patients ask me what is so important? Why is this drug, how is it different from just a regular artificial tear? Well, it's non-aqueous. It's much smaller. It has a long surface tension over, uh, uh, on the surface of the eye. Um, it's fast spreading. It's lubricating. It has film forming properties, preservative free with minimal blurring. So how did this drug actually get approved? It underwent two clinical trials, the Gobi and Mojavi, and for primary efficacy, it met both signs and symptoms were met for total corneal fluorescine staining at day 57 and actually the visual analog dryness scale at day 57 as well. And when you look at their key secondary endpoints, improvements were shown as early as 15 days looking at total central corneal fluorescine staining and, uh, and, uh, total corneal fluorescine staining as well as some other VAS criteria with dryness, um, burning and stinging. Now how does one incorporate this drug into a dry practice? Well, many times I'd like to use it as primary therapy, especially if I think they don't need a calcineurin inhibitor. But unfortunately in this day and age, uh, age, I'm very much dictated by what insurance companies say and do, and I have to do this stepwise approach where they have to fail other therapy, uh, other therapies before I can actually prescribe this medication. So real quick, fast fire approach, the other FDA approved medication that has worked quite well over the past couple of years is Lodolanor, and what is that? It's a novel therapeutic designed to eradicate those pesky Demodex mites and to treat Demodex blepharitis. So Lodolanor, how does it work? It's a potent non-competitive antagonist of insect and arachid GAA chloride channels. So it affects those channels, but it doesn't affect any human cells. So it's quite safe. And the lipophilic nature of this drop enables it to flow into the lash follicle, so you don't have to rub it in. Um, and how is this drug approved? Two successful trials looking at various endpoints cholera cure, mite eradication, and lid erythema cure. Um, since a picture is worth 1000 words, I think it's important to point out to look at patients' lashes and their campaign, the company's campaign about looking down, I think is spot on because if you don't look down, you won't see the scarf, you won't see the colorettes, and many of my patients who are coming in with this degree, 3 to 4 degrees of, um, colorettes, after 6 week treatments, their lids do truly, uh, clean up. And this is also shown uh that they, a majority of patients get pretty good cholera cure in both of the clinical trials um with any drug, any drop I tried them all, it does sting, it is a little bit uncomfortable on the surface of the eye, but 91% of subjects reported, uh, the drop to be pretty neutral or comfortable. Um, and the next question I get asked, uh, by, by many patients is, does the effect last? Well, if you use this drop twice a day for about 6 weeks, many patients, this result will last 6 to 9 months, and this was shown in their extension trials. And then lastly. The company is doing something quite interesting. They're looking for another indication for this drug. We know it can help with Demodex blepharitis, but what does it do to the mybomian glands? And in their phase two trials, it looks like it does have an effect in treating the mibomian glands. So I think in the future you don't actually have to look for scurf or cholerette's. If patients have myboming gland dysfunction, this drug may help. Uh, the last question that patients ask me all the time is. What are these mites? Where did they come from? I've never heard of these mites. How did I get them? So then I, um, direct them to the, to one of my favorite videos. Can you play the video? You know what I saw on TV? There are bugs that live in your eyelids and you It's gross. Jeez, now that's my list of worries. I know your eyelids are the bug's house. So anyway, a little bit of laughter after lunch. Um, this is a funny skit to my favorite comedians, but after patients, you know, understand or see what these mites can actually look like on the surface, they are, they're a little bit more inclined to for treatment. Now we can, uh, moving on to. Uh, the next drug that was approved two years ago or so, it's that newest kid or cyclosporine, cyclosporin 0.1% dissolved in the semi-fluorinated alkane per floralbutylpentane, different from the other drug that I mentioned, and this was approved for the treatment and signs and symptoms of dry eye disease. It's free of oil, surfactants. There's no preservatives. It has superior spreading properties, no pH, no osmolarity. And just to give you a chart of the different cyclosporins that are available now, we all know the traditional one that was approved back in 2002, 0.05%, 2019, another one was approved 0.09%, and the highest percentage of the one that's approved a couple of years ago. The difference being the newer one seems to work a bit faster than the tradition, the older ones, and I think the biggest selling point, it doesn't sting and and burn as much as the other cyclosporins. Um, and the this, the way that this one got approved, there were two trials, Essence 1 and 2, and they used as an endpoint a decrease in 3 grades of corneal staining, um, based on the NEI criteria. So you can see a total 12 here and a total of 9. So that's 3 grades of improvement, and a greater proportion of patients utilizing the drugs had this improvement, and these patients also had an improvement in many VAS symptoms such as dryness, blurring of vision, frequency of dryness, etc. Um, they also did an extension trial where even at 12 months, they maintain clinical clinical benefit for signs and symptoms. Uh, I would love to also use this as first line therapy, but, uh, unfortunately many times we have to do the fail first. They have to try the other calcineurin inhibitors before this drug can actually be approved. Next on, I'm gonna briefly talk about a new cross link hyaluronic acid derivative canalicular gel for customized punctal occlusion. So this has some advantages over traditional plugs. It's well tolerated. The effects can last 6 to 12 months. The ophthalmologist can easily inject 0.2 cc's of this gel into the inferior puncture, which would then loop around and come out of the superior puncture, and this will, um, act as a pretty good, uh, difference between punctal plug. You can see here in this study where they looked at 157 patients and they randomized this gel compared to a traditional plug and it did quite well in terms of ocular surface disease index scores where the patients felt very comfortable and it also did a bit better in uh Shermer's testing. Uh, next, I want to talk about the new kit on the block. What was FDA approved probably about 6 months ago, and many patients are not now trying. This is Alcultramon ophthalmic Solutions, so it's approved for the treatment of signs and symptoms of dry eye disease, and this is now utilizing neuromodulation, which we all know is important. The nerves are important in dry eye. We needed to make tears to create the blink reflex and to play a role in inflammation. So this is activating natural tear production via. The trigeminal nerve. A brief sort of introduction to the lacrimal functional unit. You know, there's various receptors on the surface of the eye, cool sensing, poly polymodal and mecanonoso receptors which send signals through aferent and efferent, uh, neurons to the trigeminal nerve that then relay back to the lacrimal gland, the mybomian gland to produce secretions to help maintain the ocular surface. So this drug, let's look specifically at the basal tear response. These cold thermosensory neurons express trip M8 channels which respond to mild ocular surface cooling to produce basal tears, as opposed to these noseo receptors that expressRV1 and tripA8 channels which respond to extreme temperatures, irritants, and, and create excessive tearing. So acultramon is a potent and highly selective trip M8 agonist. So when it's stimulates, you increase your basal, um, uh, tear secretions. This drug was approved by two studies, comet 2 and 3, and in this study their primary endpoint. Was increase in natural tear production and up to 4 times more patients achieved at least a 10 millimeter increase in the natural tear production. This increase in natural tear production also um ran throughout the entire study 90 days. We also saw that they looked at the Sandy scores, which was the frequency and severity of dry symptoms measured by this special, um, Sandy, and the global score improved in Comet 2, but it didn't reach statistical significance in 3 comet 3. But however, the drug was approved, and they did some exploratory endpoints looking at cornea total corneal and conjunctival staining which did also show an improvement. This drug, when placed in the eye, I test all of these drugs on myself, can actually sting and burn. Almost feels like putting icy hot in your eye, so it could be a bit irritating. 50% of people, um, do report an installation, um, an incidence of installation of burning and stinging, but luckily of the individuals who feel this burning and stinging, 98% say it's mild. It lasts less than a minute, and, uh, only a small proportion of patients actually had to stop the study because of the burning and stinging. Well, another recent study that was done was the question, does this drop produce just aqueous tears? Well, it turns out, yes, it does produce an increase in aqueous tears where you can see from an increase in tear meniscus height when they obtained OCTs. But it also increases lipids. So there's an, when you collect the tears, there's an increase in lipid as well, which makes it more useful as a total artificial, um, uh, total medicine to help dry eye. So this is also a graph to show the improvement in both lipid and improvement in the aqueous level of the tear film, and once again this could be a great medicine to use first line because it has secondary anti-inflammatory properties as well as increasing the total tears as well as the lipid component. Uh, but unfortunately once again with insurance companies it's tough to get this approved. It is expensive. We'll be starting a real world trial, trial, and investigate initiated trial to uh look at this, um, drug in, uh, my various different types of dry patients. Next part of my talk, I want to uh discuss two new drugs that hopefully will have PUFA dates coming up in the next 3 to 4 months and looking to get FDA approval within the year which I think will be a great value to this surface disease. Uh, the first one is selenium sulfide ointment which has a triple mechanism of action where it decreases, um, mybomian gland hyperkeratinization, loosens mybomian gland blockages, and increases secretion of mybomian gland lipids. Uh, this drug already completed a phase 2 and is still enrolling patients in a phase 3, but they looked at different formulization, different formulas of this concentrations of this ointment, looking for an endpoint where mybomian gland secretion improved and the ocular surface disease index improved as well. This is an ointment dosed twice a week, placed in the fornix of the lower lid. And their results from phase two did indeed show that the quality of MIBAM did increase and the percentage of patients with normal MIBAm increased. OSDI improved in these patients and they looked at some other, um, symptoms across multiple symptom symptom measure scores such as eye dryness VAS, looking at speed score and itching score, which also improved, um, from baseline. This ointment tends to be a bit irritating, but over the months that they've used, looking at the various different, um, AEs such as corneal staining and eye pain, this did decrease over the 6 months of use which is um, is a good thing because you want these patients to be on this drug, um, in terms of their clinical data review I'm hoping this drug gets approved within the next year because of its strong trial efficacy um it seems that it tends to restore gland function and patient symptoms also improved. Uh, next up, which will also have a PUFA date within this next, uh, 6 months and hopefully approved, is reproxolab, and this is a RASP inhibitor. So this represents a novel potential therapeutic approach in dry disease that has a rapid and sustained symptom improvement, broad symptomatic activity, and acute reduction. Of ocular redness, how do rasps work? Well, the rasps are formed by oxidation of alcohol and other metabolic processes. Uh, they bind thol and amine residues on proteins, and this leads to confirmational and functional changes in certain proteins that initiate pro-inflammatory signaling cascades. RASP tends to work at the top of the inflammatory cascade as opposed to calcineurin inhibitors or steroids which work a bit further down. There's, there have been numerous papers to support the use of these RASP modulators over the past several years, and this is they've done some of their clinical trials in a traditional way, but they've also utilized dry eye chambers. And since dry eye disease is a disease that is characterized by exacerbations, these chambers regulate temperature, humidity, air flow, and expose partic participants to conditions that force the ocular surface to react to added stress. So this creates a nice controlled condition to study dry patients. And in their previous studies looking both at field clinical trials and dry chamber clinical trials they looked at a few end points that being ocular dryness symptoms, discomforts scores, and conjunctival redness, and it performed quite well in all of these scores. The discomfort score, it, it did well, uh, dryness score and redness as you can see in these graphs. In one of their studies called Tranquility 2, they also looked at, um. Two primary endpoints which were increased Shermer's from baseline and greater than a 10 millimeter increase in Shermer's which it did well um in both of these parameters and consistent with some of their prior trials there were no clinically significant safety signals. Um, a few words about allergic conjunctivitis that can go hand in hand with dry eye. Uh, we know that pollens, pollutants, and parched environments can exacerbate allergies, can also exacerbate dryness, so it's important to consider allergy, and this drug has the potential to be the first novel drug for allergic conjunctivitis. Both ophthalmologists and optometrists that were polled said they would welcome this drug to help treat patients with moderate to severe allergic conjunctivitis, adjunctive treatments to antihistamines, and also a treatment. In lieu of corticosteroids, as we know, has many side effects. Uh, they did a phase 3 allergic conjunctivitis trial called the Invigorate where they in, in both Invigorate, um, 1 and 2 they did see, uh, an improvement in the mean ocular itching score. Um, this drug is interesting for me. It becomes improved because this has a novel mechanism of action, and the way I look at it is I'll be killing two birds with one stone dry eye and allergy all in one shot. Few words to talk about um a drug that's being investigated right now in clinical trials, progesterone gel, which is a novel mechanism here too because it's transapendageal forehead delivery. This is a gel that you place on your forehead and it's believed to alter COs sign signaling via the ophthalmic nerve to the brain stem regions related to tear film production. And pain modulation this interests me because they are a subcategory of patients with dry eye that develop pain and neuropathic pain so this drug, if it helps dryness and pain could be a winner. however, it's still in clinical trials. Some of their preliminary results in patients with dry eye and graft versus host studies have shown improvement in central fluoresce sustaining. Staining and improvement in Sandy questionnaires. Um, I'm hopefully here at NYU and the team will be starting an investigator initiated trial to see how this drug works in the real world. So stay tuned about this. I wanna say a few words about regenerative medicine and where the future is going. We are all very familiar with autologous serum. Um, there is a company now that's producing a qualified autologous serum that has a patented protocol that is stable at room temperature. A lot of these autologous serum drops, as you know, have to be kept refrigerated, which is difficult for patients who work or travel, so this could be a novel and good addition. There are various amniotic membrane extracts with a cellular biologic material to help heal the ocular surface that are out there. Exosomes with tiny vesicles from stem cells that can be used in drop form to heal the surface. There's an ophthalmic biologic solution utilizing allogeneic and standardized human platelet lysate to help heal the surface. I have worked for um. As a on an ad board for a company looking at a regenerative biologic drop using induced pluripotent stem cells to create platelet-like cells also for healing of the surface and then lastly just a few words about oh there are always newer and sometimes better, sometimes not better cryopreserved and dehydrated amniotic membranes that also do play a role in healing the ocular surface but where's the future going? I think the future is going into the direction of personalized medicine. I'm looking forward to using these point of care test kits where I can analyze the tear fluid and actually see what cytokines are increased, what cytokines are decreased, because we know in dry eye there's a slew that are increased, some that are decreased, and that way I could use targeted therapy as a. Opposed to throwing a drug and hope at them and hoping that it'll work, you know, if their ICA is elevated, I can use lafidograst. If their IL-6 or IL-17 is elevated, I might do intense pulse light therapy, which has been shown to decrease those two cytokines. So personalized medicine is the way to go. And just one, word about just technology and how much it's advancing. We just purchased a very fancy piece of equipment that takes beautiful pictures of the ocular surface looking at mybomian glands, looking at the pupils, looking at inflammation, looking at, uh, redness, um, and this also has wonderful AI algorithms built into it along with questionnaires that can actually help to diagnose and better treat dry eyes as mentioned earlier. We have a specular microscope that's actually quite amazing. The only one in the United States. Not only does it take beautiful pictures of the endothelial cells, I'm now utilizing it to look at corneal nerves, and we've started a study looking at all my dry patients, my neuropathic pain patients will be presenting that at Arvo, but this comes at a great time because, as many of you may. May not know it's very hard to purchase a confocal microscope right now and if you have one, you can't get it serviced. And since the nerves play an integral part of dry eye, I need to see what my nerves look like. So hopefully this wonderful machine can help, uh, me and other ophthalmologists analyze the nerves. We also have some beautiful newer pieces of equipment for intense pulse light. Um, there is a handheld instrument that, uh, does dynamic muscle stimulation of the periorbital area that's been published so that it can improve blinking and help dry eye, and like I mentioned, I try all these drops and instruments on myself so the patients can't tell me you don't know what it feels like, and I say yes I do, um. But anyway, in conclusion, new treatments are promising in the treatment of lid margin disease, secondary evaporative dry eye, tear insufficiency dry eye, allergic conjunctivitis, personalized and regenerative medicines the way to go. AI is gonna help us tremendously to improve diagnosis and treatment. Continued innovation in the space will give us new tools in the management of ocular surface disease. Thank you. Published January 30, 2026 Created by
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