SLIDE 1 | Good evening, and thank you for allowing me to share your evening with you. My name is David Richardson, and I’m in private practice north of here in the San Gabriel Valley. Tonight I would like to introduce you to a new glaucoma procedure, Canaloplasty – one that I am very enthusiastic about.

SLIDE 2 | First, you should know that I am a consultant for iScience and I am biased. Not because I’m a consultant. Rather, because I am unapologetically enthusiastic about this procedure. This enthusiasm predated my consulting so although I admit to bias, I hope you will feel after this talk that there has not been any conflict of interest.

SLIDE 3 | My intent is not only to introduce you to a less invasive surgical treatment for glaucoma, but to get you to start thinking about glaucoma from your patients’ perspective. As doctors, we tend to think of diseases in terms of their pathophysiology and treatment (be it medical or surgical). However, what is it we are really treating? Yes, the patient. But, what does the patient experience with glaucoma? A: Loss of vision ? Really? When does that happen? Do glaucoma patients present with loss of vision? No. So then, what are we treating? A: IOP. Yes, from our perspective. But what is the problem with treating IOP from the patients’ perspective? A: They are symptom-free. Yes! And what does our treatment do to these symptom-free patients?A: Give them symptoms. Exactly! Glaucoma IS a Lifestyle disease Why? Because we (as doctors) make it so Our TREATMENT negatively impacts the lifestyle of our patients

SLIDE 4 | Let’s start with drops. What is the first thing your patients say when you pull out your prescription pad (or start typing up an Rx in you eRx program)? A: “Will this be covered?” Right. Makes you wonder if patients really want to be treated? Well, in the case of glaucoma (and diabetes, and hypertension) they really don’t. We, as physicians, are from the moment we initiate treatment of glaucoma, making the lives of our patients worse. In that moment. I’m not arguing about the future saving of vision. I’m focusing on the “right here, right now” Glaucoma medications are EXPENSIVE! It’s not uncommon for a branded medication to be $80+ (and that’s with insurance coverage). Yes, generics are available, but are they equally effective? What has been the experince so far with generic Cosopt? My experience has been that the Hi-Tech brand is about as useful as artificial tears but with stinging. How about Latanoprost? My experience has been that is works, but the savings are less than stellar.

SLIDE 5 | So let’s pretend that the patient in front of you with newly diagnosed glaucoma is Bill Gates and is unconcerned about the cost of his treatment. Anything else that he might not be happy about (besides having one more thing to add to his busy day)? Side Effects. All drops result in some form of ocular irritation. You may get a nice ocean breeze here in Orange County, but up in the San Gabriel Valley where I practice it’s hot and dry. My single most common diagnosis is Dry Eye Syndrome, closely followed by Glaucoma. The last thing I want to do is worsen the already bothersome symptoms of dry eye experienced by my patients. Cosmetic Effects: we are all aware of hyperemia that most patients get with any of the topical medications. And we may couch the prostaglandin side effects within the benefit of long lashes, but now it appears that one side effect, Prostaglandin Associated Periorbitopathy may even make it difficult to obtain an accurate IOP measurement. Allergy. Sure, we can stop the drop. But, let’s be honest here, don’t those alpha-agonist allergy patients just look miserable. I, for one, always feel empathetically guilty whenever one of my patients comes in with a full blown allergy to alphagan. Systemic effects: We’re taught that the beta blockers should be OK in patients who are not elderly, infirm, or hypotensive, but this simply is not the case. I recently trial a young 50ish male with no know medical conditions on timolol. That weekend he ended up in the emergency room. Thank God I warned him of the possible side effects and he was very good natured about it (considering).

SLIDE 6 | I think most of us feel pretty good about the safety profile of laser trabeculoplasty. However, there are a few things to consider. Rare but serious IOP spike Doesn’t work all that well here in the US (after drops exhausted) Scarring of trabecular meshwork and stenosing of Schelmm’s canal can negatively impact the success of future therapy

SLIDE 7 | Trabeculectomy Since I am reviewing glaucoma treatments from the patients’ perspective right now I’m going to skip over the early post-operative issues associated with Trabs. Long term impacts on Patients: Hypotony (worsens vision) Chronic irritation secondary to the bleb Mitomycin-C related risk of bleb leak and endophthalmitic (resulting in a total loss of vision) Active lifestyle limitations Soft contact lens use Water sports

SLIDE 8 | What about shunts and tubes? – Hypotony (at least with non-valved tubes) Diplopia Chronic irritation Corneal decompensation Chronic iritis Late erosion

SLIDE 9 | Is this a bad thing? I mean, subjecting our glaucoma patients to all of these costs, side effects, and risks? From the perspective of the alternative, eventual complete loss of vision, no. But we must accept that the present reality of most current glaucoma treatments is that patients pay now (in symptoms) to save vision in the future.

SLIDE 10 | “ First, do no harm” Even those of us who have not sworn the Hippocratic Oath accept the Latin command. Can we say this with our current glaucoma treatments? To be fair, we are subjecting our patients to these costs, side effects, and risks with the honorable intent to save them from a future life without vision. After all, total blindness used to be the norm with glaucoma. In that sense, these treatments (though not perfect) are only mildly short of miraculous. OK, so let’s for the moment agree that prevention of future blindness is worth the cost, side effects, and risk of treatment. Is that the end of the story? I’m afraid not…

SLIDE 11 | These are the exact words said to me by one of my glaucoma patients after having a trab in one eye and being told she would need a trab in the second eye to control her glaucoma. She clearly felt that the treatment of glaucoma was worse than the disease itself. But, we (as doctors) know better than this patient, right?

SLIDE 12 | Patients no longer just listen to and act on a doctor’s advice “ Orders” have morphed into “Professional Suggestions” Anyone here in practice for over twenty years? Yes, tell me this. 20 years ago if a patient was having a side effect on a medication you prescribed, what would they do? Call you before stopping. What do patients do now? Stop taking it and wait until they see you to let you know that they’ve not taken it. What is the other common reason patients stop their meds without letting you know? I call them the Irritating “I”s: The insert and the internet.

SLIDE 13 | “ Psychodynamics” is a marketing term, so what’s it doing in a medical talk. After all, I know that we were all taught in medical school that marketing and sales were naughty words. B ut from marketing we can actually learn a lot about our patients (and therefore how best to approach treatment with them). A brief article in the New York Times about marketing to baby boomers had a few key points that can help us as we recommend treatment for our glaucoma patients: A significant segment of the Baby Boomers view themselves as active, “ageless explorers” and are not going to appreciate anythign (such as a bleb) that is going to limit their ability to stay active. They do not like to be reminded that they are growing old. Glaucoma drops are a daily (sometimes multiple times a day) reminder that they are getting old. After all, glaucoma is generally viewed as a disease of the elderly. Not only do they not want to be reminded of their advancing years, but they may even take steps to actively deny it. Have any of you noticed a trend in newly diagnosed glaucoma patients seeking second and third opinions about glaucoma before they are willing to accept the diagnosis? I have. As the only canaloplasty surgeon in my area, I get a lot of patients coming to me not just for canaloplasty, but for their third or forth opinion regarding the presence or absence of glaucoma. And, believe me, if there is even one doctor (OD or MD) that has suggested that they do not have glaucoma, good luck convincing them otherwise. I’ve shown patients OCTs that are flatlined and visual fields with clear arcuates and been met with “well, my eyes felt a little dry that day, can we repeat it before starting drops?”

SLIDE 14 | How can we prevent future loss of vision in a group of patients who are: Focused only on the “now” Not willing to curtail their activities Are ambivalent about our medical advice In active denial about their aging

SLIDE 15 | Give them something they want And, what is that? What do Baby Boomers Want? To “fix” their glaucoma A surgical treatment would be ideal, but the standard surgeries violate the following: To maintain their lifestyle Not possible with a trab if they use soft contact lenses or enjoy watersports. To keep their mental image of youthfulness Hard to do with the constant reminder of drops and worsening of dry eye symptoms (drops and bleb) Basically, not to be bothered – None of the current topical or surgical gold standards meet the needs of the Baby Boomers

SLIDE 16 | The ideal glaucoma treatment would meet the following criteria: Surgical (no drops) Safe (few risks – baby boomers do not want to risk vision today to save for vision tomorrow) Long lasting (too active to be bothered with staged treatments and frequent follow up) Few side effects (not going to be happy with chronic irritation) Believe it or not, there is a category of glaucoma surgeries that have met these criteria for over two decades.

SLIDE 17 | The Non-Penetrating Glaucoma Surgeries meet these criteria. For example, viscocanalostomy has been performed for decades in South Africa and Europe with an impressive safety record. A recently published study showed that patients who had undergone phacoviscocanalostomy experienced (on average) a sustained reduction in IOP of 30% from preoperative levels seven years out from surgery. However, they have not met with success here in the US as they:

SLIDE 18 | Were technically challenging Did not compare favorably to trabeculectomy Were not reimbursed That is until…

SLIDE 19 | Could Canaloplasty change that? It has for me and my patients. In brief, canaloplasty involves the following:

SLIDE 20 | Creation of a superficial flap (similar to what is done with a trab) Creation of a deep flap Extension of the flap into cornea creating a Descemetic window Catheterization of Schlemm’s canal Viscodissection and stenting of the canal with a Prolene suture Closure of flap

SLIDE 21 | The iTrack microcatheter is what makes this all possible. It is a flexible catheter with a beacon tip allowing for visualization and confirmation that the catheter is where you want it to be. SLIDE 22 | Here is an image showing the beacon shining through the overlying tissue as the catheter is retracted back through the canal. SLIDE 23 | Once the Prolene suture has been pulled through the canal, it is tied creating tension on the inner wall of Schlemm’s canal.

SLIDE 24 | So, back to the criteria needed to satisfy the Baby Boomer with glaucoma, Canaloplasty is clearly surgical. But is it safe?

SLIDE 25 | So that’s how it’s done. Is it safe? Well, comparison of 3 year results of canaloplasty with a National Survey of Trabeculectomy suggests that it is at least as safe as trabeculectomy without all of the bleb-related issues. You should have a copy of the three year results in the packet given to you so I’m going to review them quickly so as to get to the video. Of note, is that in the 2.5% of canaloplasty patients who did have a bleb three years out, these blebs tend to be low-lying and minimally exacerbate ocular surface disease (if at all). Note, however, that this does not compare hypotony maculopathy which essentially does not happen with canaloplasty, yet is a known complication of trabeculectomy (especially in high myopes)

SLIDE 26 | At least in comparison to the gold standard of glaucoma surgeries, trabeculectomy, Canaloplasty is safe. But, does it last?

SLIDE 27 | Does the IOP lowering effect of canaloplasty last? Well, it does for at least three years. These are the results of a prospective international study of canaloplasty: Those who had canaloplasty alone enjoyed a sustained reduction of IOP by 34% And reduced their medication use by over 50% Those in the combined phacocanalopasty group enjoyed an even bigger response: 42% reduction in IOP and 81% reduction in medication use (in fact 88% of these patients were off ALL meds after phacocanaloplasty) (and there is reason to believe that it should last for at least 7 years). A recent study looked at long term results of phacoviscocanalostomy. 7 years out there was a sustained reduction of 30% in patients who had had this combined procedure.

SLIDE 28 | With regard to long-lasting, we can at least state that the effects of Canaloplasty last for three years, and based on the recent study of viscocanalostomy I mentioned earlier, I think it is reasonable to anticipate that the effects should last much longer. So, from the patient’s perspective, Canaloplasty is looking pretty good.

SLIDE 29 | What about side effects? Well, let’s see. What are most of the side effects due to? Ocular surface disease. And what exacerbates that? Drops and blebs. And, since with canaloplasty most patients are able to decrease their drop use by over 50%, the ocular surface disease tends to get better after Canaloplasty. A bonus is that some patients actually see better after Canaloplasty (something that I’m sure you’ll agree is rare after trabeculectomy). … and, of course, if there is no bleb, there is no bleb-related dystesthesia, no “popping sound when I blink,” or other bleb-related annoyance. But, that’s still not the end of the story. It’s nice that Canaloplasty can meet our demanding Baby Boomer list of requirements. But, the question many of you here are thinking is “How Does It Compare to Trab+MMC?”

SLIDE 30 | Ike Ahmed took a look at this and first presented his results at the ASCRS in 2010.

SLIDE 32 | This gets to the “Lifestyle” concern that was discussed earlier. Vision is certainly a lifestyle concern. Baby Boomers want: Faster recovery (shown here) Excellent vision (a bonus with canaloplasty which is most likely due to the improved ocular surface after CP – something we do not see after a trab because of the bleb). With canaloplasty you essentially remove one of the main factors in symptomatic dry eye in glaucoma patients: the drops without exchanging them for a dry eye exacerbating bleb. Additionally, there are NO long term lifesyle contraindications with regard to activities. Patients are allowed to return to both contact lens use and water sports after the surgical site has healed.

SLIDE 33 | So it appears that Canaloplasty can be about as good as a trab (as least by a minimally talented surgeon such as Ike Ahmed). But, isn’t it technically challenging? Yes, it is. So I’m going to leave that “x” up if for no other reason than to support my assertion that although biased, I am not viewing canaloplasty thought rose colored glasses (that’s FL-41 tinting for your photophobic post-trab patients). Canaloplasty is not easy to master. Then again, neither was phaco when most of us learned how to do that. I’ve heard the learning curve of canaloplasty described as “steep.” Sure it is, compared to something like the Express or i-Stent. This surgery does not just involve sticking something extra into the eye. But the steepness of the canaloplasty learning curve simply does not compare to phaco, so anyone in this room who considers himself or herself a talented phaco surgeon can master canaloplasty. You are all welcome to talk to me at length after tonight’s talk about any of the points I have made (but especially this one). OK, we’re done with the touchy-feely “what does the patient want” as well as the dry academic stuff. Let’s get down to brass tacks: Is it reimbursed? And, let’s see some video.

SLIDE 34 | This year a new category I CPT code was introduced: 66175 for which Medicare reimburses more than a simple trabeculectomy but less than trabeculectomy with Mitomycin-C. Don’t ask me what their reasoning was for this RVU determination. So, how much time do we have for the video?

SLIDE 35 | So I hope I’ve given you some things to think about as you evaluate and treat your Baby Boomer glaucoma patients. It appears that we don’t have any time for questions and answers now, but I’ll hang around for a little while after the meeting and am available both by email and phone for anyone who is interested in discussing canaloplasty in more detail.

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