Glaukos Corporation

The company's press release and quarterly summary document, both issued after the market closed today, are available at www.glacos.com. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this presentation, simply press star followed by the number one on your telephone keypad. If you would like to withdraw your question, again, press star one. This call is being recorded and an archived replay will be available online in the investor relations section at www.glacos.com. I will now turn the call over to Chris Lewis, Vice President of Investor Relations and Corporate Affairs.

Thank you and good afternoon. Joining me today are Glacos Chairman and CEO Tom Burns, President and COO Joe Gilliam, and CFO Alex Thurman. Similar to prior quarters, the company has posted a document on its investor relations website under the financials and filings quarterly results section titled quarterly summary. This document is designed to provide the investment community with a summarized and easily accessible reference document that details the key effects associated with the quarter, the state of the company's business objectives, and strategies and any forward statements or guidance we may make. This document is designed to be read by investors for their regularly scheduled quarterly conference call. As such, for this call, we will make brief prepared remarks and transition into a question and answer session. To ensure ample time and opportunity to address everyone's questions, we request that you limit yourself to one question and one follow-up. If you still have additional questions, you may get back into the queue. Please note that all statements other than statements of historical facts made on this call that address activities, events, or developments we expect, believe, or anticipate will or may occur in the future are forward-looking statements. These include statements about our plans, objectives, strategies, and prospects regarding, among other things, our sales, products, pipeline technologies and clinical trials, U.S. and international commercialization, market development efforts, efficacy of our current and future products, our competitive market position, regulatory strategies, and reimbursement for our products, financial condition, and results of operations, as well as the expected impact of general macroeconomic conditions, including foreign currency fluctuations on our business and operations. These statements are based on current expectations about future events affecting us and are subject to risks, uncertainties, and factors relating to our operations and business environment, all of which are difficult to predict and many of which are beyond our control. Therefore, they may cause our actual results to differ materially from those expressed or implied by forward-looking statements. Review today's press release and our recent SEC filings for more information about these risk factors. You'll find these documents in the investor section of our website at www.cloudcoast.com. Finally, please note that during today's call, we will also discuss certain non-GAAP financial measures, including results on an adjusted basis. We believe these financial measures can facilitate a more complete analysis and greater transparency into Glaucos' ongoing results of operations, particularly when comparing underlying results from period to period. Please refer to the tables in our earnings press release available in the investor relations section of our website for reconciliation of these measures to their most directly comparable GAAP financial measure. With that, I will turn the call over to Glaucos Chairman and CEO, Tom Burns.

Okay. Thanks, Chris. Good afternoon, and thank you all for joining us today. Today, Glaucos reported third quarter consolidated net sales of approximately 78 million, up 10% versus the year-ago quarter. These third quarter results reflect continued strong performance and execution across our key franchises globally. Given these results and our latest forward outlook, we are raising our 2023 net sales guidance range to 307 to 310 million versus 304 to 308 million previously. From a commercial perspective, strong execution of key strategies within each of our core franchises drove the solid performance. Within our U.S. glaucoma franchise, we delivered sales of 38.1 million on growth of 2% year over year as we experienced more pronounced seasonality headwinds in August, offset by continued strength in July and September. Consistent with prior quarters, we continue advancing ISPENT Infinite ahead of establishing formal MAC coverage and payment. On that front, just last week, WPS, one of the seven MACs, published an updated MIGS LCB with a future effective date of December 24, 2023, that provides coverage for ISPENT Infinite consistent with FDA approval and our reconsideration request. We are pleased with this final outcome as it relates to High Stand Infinite, but we're disappointed at other aspects of the LCD that severely restricts clinical decision discretion for surgeons fighting a site-threatening disease. Looking ahead, the remaining six MACs have all taken preliminary steps to assess High Stand Infinite coverage, including four through proposed LCDs and two with local coverage articles. We continue to monitor the various MAC processes and policies as they advance and are ultimately finalized in the future as we remain supportive of expanding broad access to interventional glaucoma tools for physicians and for patients. While we await the release of CMS's 2024 final rules, we remain encouraged that, as part of the 2024 proposed rule, the CPT code used to cover iStand Infinite in standalone procedures 0671T was lifted to APC 5492, and the APC assignment for combined cataract plus trabecular bypass procedures 66989 and 66991 was proposed to move to a newly restructured APC 5493. If finalized as proposed, We do believe these changes, while positive for our customers and our procedures, may create some transient disruptions to ordering patterns in late 2023 ahead of becoming effective on January 1, 2024. Moving on, our international glaucoma franchise delivered sales of $20.3 million on strong broad-based year-over-year growth of 23% on a reported basis and 20% on a constant currency basis. The strong growth was once again broad-based as we continue to scale our international infrastructure and execute our plans to drive MIGS forward as a standard of care in each region and every major market in the world. While we focused on our near-term execution, we are also accelerating efforts to support one of our founding missions at Glaucus, which is to advance glaucoma care by driving intervention of therapies earlier in the treatment paradigm for glaucoma disease and in turn pioneering a new standalone market over time. We continue to lead and work closely with surgeons and thought leaders globally to organically drive this broader revolution in the standard of care, including through numerous events at the ESCRS Annual Meeting in Vienna in September and the Interventional Glaucoma Consortium in Salt Lake City in October. These efforts will once again be on full display at the upcoming AAO annual meeting being held in San Francisco this weekend. And finally, our corneal health franchise delivered record sales of $19.7 million on 12% year-over-year growth, including for Trexa record sales of $17 million on a year-over-year growth of 18%. as key strategic initiatives implemented throughout the past year continue to take hold in support of this important business. Similar to our U.S. glaucoma franchise, our U.S. corneal health business experienced more pronounced seasonality headwinds in August, offset by strength throughout the remainder of the quarter. Gifting gears to the development front, we continue to prudently invest and successfully advance our robust pipeline of novel, promising platform technologies that we believe have the ability to significantly expand our addressable markets and fundamentally transform our company over time. Starting with iDose, we continue to be encouraged as we work closely with the FDA in their ongoing NDA review process. During the third quarter, we successfully completed the required pre-approval inspection, or PAI, of our new state-of-the-art hybrid pharmaceutical manufacturing facility. notably with no 483 observations. For a company going through this type of rigorous pharmaceutical review for the first time, I could not be more pleased with this unblemished outcome and would like to recognize our operations, development, and quality teams that drove this result. Based on our productive mid-cycle review meeting with the agency held in August, we remain confident in the agency's decision by the PDUFA date of December 22, 2023. Alongside this, our teams are increasingly advancing preparation and planning efforts to support the IDOS commercial launch targeted for early next year, including a robust set of peer-reviewed literature expected to be published over the remainder of this year and into 2024. Our robust publication plan includes four manuscripts that have already been submitted to leading journals and at least five others that are planned for submission. Shifting gears to Apioxa, our next generation corneal cross-linking therapy, we continue to advance patient follow-up in the second phase three pivotal study and remain on track for our targeted NDA submission by the end of 2024. Beyond sidosis and epioxa, we recently commenced a PMA pivotal study for isin infinite in the mild to moderate glaucoma population and expect to begin first in human clinical development for one of our retinal programs, along with a phase 2A study for ilution travel process by year end respectively. So as you can see, we have a lot to be excited about when it comes to the significant potential value that we believe our pipeline programs may create. At the same time, and as we have discussed, we continue to prioritize the cadence of our investments as we strive to strike the right balance of risk-based spending and our capital position now and in the future. We are pleased to see evidence of this again in the third quarter as our non-GAAP SG&A and R&D operating expenses grew at a modest 1% sequentially, reflecting some of the adjustments we've made in our earlier stage pipeline programs as we continue to prioritize our resources ahead of the anticipated IDOS commercial launch early next year. So in conclusion, I am pleased with the continued execution and performance in our business as we continue to successfully advance our mission to truly transform vision by pioneering novel, drop-less platforms that can immediately advance the standard of care and improve outcomes for patients suffering from sight-threatening chronic eye diseases. Our foundation is strong, and we are well-positioned as we enter into what should be a transformational period for our company in the years ahead. So with that, I'll open the call to questions. Operator? Operator?

Perfect. Thank you. At this time, I would like to remind everyone, in order to ask a question, press star, then the number one on your telephone keypad. We'll pause for one moment to compile the Q&A.

All right. Our first question comes from the line of Tom Steffen.

Tom, please go ahead.

Great. Hey, guys. Thanks for the questions. I want to start off with the LCDs. Maybe if we assume the remaining four MACs align with WPS, can you guys just talk first about the ways the company, from a strategic perspective, is aiming to capitalize on any of the changes or just potential uncertainty that probably will ramp in the market next year? And then maybe qualitatively, you know, how should we be thinking about any sort of net tailwind for glucose next year from the LCDs?

Hey, Tom, thanks for the questions. It's Joe. I'll start off on this one. You know, from a macro standpoint, I think, you know, really I would reiterate some of what Tom said in the prepared remarks. First and foremost, at least in the first LCD that we've seen from WPS and what we would likely expect to see from at least the other four MACs that seem to be in a similar place, is most importantly coverage for ISDN Infinite. For us, it really starts there, and that was the totality of our efforts around this and trying to make sure that patients were getting access to ISTEN Infinite as intended. And thankfully, on that front, WPS and hopefully other LCDs established that proper coverage that we requested for ISTEN Infinite. You know, beyond that, obviously, we're disappointed in the context that the activity or the final LCD as drafted really takes a step towards removing that clinical decision-making from the clinician's hands. And so, you know, for us, that's going to be something that we have to work on for some time, try to make sure that we can play our part in getting those decision-making capabilities back in the hands of the surgeons who are making the call on behalf of their patients. As you think about it, for us, you know, you asked quantitatively how we think about it. I think, you know, in 2023 and the remainder of this year, we expect some short-term ordering volatility, you know, headwinds, if you will, in December especially, as some accounts may prioritize non-stent-based procedures ahead of the final effective dates for a variety of reasons, but Most importantly, probably burning off any inventory that they have on their shelves ahead of a change in policy like this. And as we turn into 2024, you know, what I'll say is we're evaluating the impact and we're going to continue to do so as these other LCDs are finalized. I think I would probably just say I'd caution investors in the interim as the WPS LCD, it does contain a lot of puts and takes.

as it relates to you know our product portfolio and we really have to go through the totality of that before we can comment with any more specificity on what it may or may not mean for 2024 and beyond got it maybe one quick follow-up when you talk about kind of the short-term volatility are you starting to see that or or i guess what's informing that view um and then maybe i can get one more quick follow-up um

Yeah, I wouldn't say that we're seeing it in that way. This is more of an anticipation thing. I think anytime you go into a change in reimbursement policy like that, and we've seen this in the past where things have adjusted, obviously the customers themselves have to adjust what their either treatment algorithms are or the stock they have on their shelves. Most are not going to sit around and hold that inventory and past those effective dates is what you'd expect. And so as they get closer to that date, we certainly would anticipate that they'll use that inventory up, they'll go to more of a just-in-time kind of ordering process, and then they'll adjust as, you know, the new year starts to unfold and they've changed whatever algorithms they have from a treatment perspective.

Got it. Maybe I'll call this question 2B. But pivoting to IDOS, I wanted to ask about just doc trainings. Joe or Tom, any sense you can give us for how to think about the ramp in 2024? Will it be kind of deliberately methodical early on as you work through establishing full reimbursement? And then what's kind of a reasonable annual cadence of doctor trainings in the first couple years, sort of as we refine our models? We looked back at the ISTEN training ramp. There were periods early on that I think you trained 700, 800 physicians per year. And that's when MIGs were much less well-established. But now you have, what, 5,000 plus MIGS trained doctors. So for Eidos, is it reasonable to think doctor trainings could approach 1,000 per year for the first couple of years? Thanks for taking the questions.

No problem, Tom. You stuck three in for one. But we'll go ahead and honor it. It's all good. From a doctor's standpoint, we're going to take the same approach we've always taken. And so I wouldn't say even just the beginning. I'd say for the entirety of 2024, we're going to be methodical as it relates to driving superlative outcomes in the case of the doctors that we're training on iDose. We've always done it that way. Now, obviously, in those early days, let's call it in the first half of the year, we that'll be even more the case and that will go out to a handful of surgeons that we know work well in these early stage training situations, make sure that we've nailed down the training algorithm for our sales force before we start to expand from there. I think the other key gating item that I would point to as it relates to the pace of training is reimbursement itself. As you transition from a miscellaneous code to a permanent J-code, as you start to establish more regular and recurring payment on the professional fee and even the facility fee side associated with IDOS, more and more surgeons and their practices will be ready, willing, and able to be trained. And so those things also play a role in this. You know, you referenced historical statistics, and they're accurate. I think at our peak, we were training somewhere between 700 and 800 docs a year. on the iStent technologies, first generation, a lot of which was teaching them angle-based surgery. As we move forward, I think that lift on the angle will be a little bit less. So we would, you know, have expectations that as we hit a steady run rate that we can train, you know, more doctors than that 700 to 800, you know, historical run rate with iDose. But to get more specific on that, it's hard until we really get at that stage of the deployment.

Very helpful. I'll keep it to one next time. Thanks, guys.

Thanks, Tom. All right. Our next question comes from the line of Ryan Zimmerman from BTIG. Ryan, please go ahead.

All right. I'm going to stick to the rules here and ask just the one in the follow-up. So number one, I'm going to ask for Tom. Tom, you're in the process, I think, of having conversations with FDA about labeling the eye dose. I don't know what you're comfortable saying, but what can you say in terms of kind of where you're at and the early read on what the label could look like for IDOS?

Yeah, right. I'm happy to respond. And as you, I think you stated earlier, these would be highly preliminary. And most of these would be based on our debriefing from the mid-cycle review that we had mid-year. So what I will tell you is we have yet to receive a draft label. So as we said previously, while we're confident in the strength and robustness of our clinical data, you never know for sure where the label will land and whether the FDA will view the data using the same prism as we do until that process is finalized. What I will tell you is that we remain confident that we're tracking towards the PDUFA date of December 22nd, but that's really as far as I can assure you at this point.

Okay, fair. We'll have to wait until the 22nd of December. Second question for me, just with the LCDs likely finalized from what we saw with WPS the other week, I'm less concerned with how this impacts your surgical business and more interested in how you think about de-risking the iDose launch next year. So, you know, how does it change your calculus on iDose and what you need to achieve next year? I mean, when we spoke kind of mid-quarter, you know, you were messaging that second F24 really would be, you know, the inflection for iDose. but I have to imagine that this takes some pressure off of the first half of the year because there is some benefit that will come from the LCDs. And so, you know, how has that in the past week maybe shifted your thinking on the cadence for iDose next year?

Yeah, Ryan, I think, I don't know if I would make that far of a leap in the context of the LCDs as it relates to iDose. I think the key drivers of iDose in 2024 go back to a little bit more of what I said previously. It's really going to come down to the pace in which we can and are comfortable training these doctors and the pace in which you establish predictable recurring reimbursement, particularly on the facility and the pro-fee side alongside of that. So you want to get through the miscellaneous J or C code phase. You want to get through the initial stages of determining regular and recurring professional fees and that you're going to get paid on the facility side. I think those are the things that ultimately shift a lot more of the, you know, shifting from the walk into the jog, into the run, to the back half of the year versus the first half. You know, it is possible that across all of our portfolio, there'll be incremental demand associated with procedures, whether that be stinting. But I think IDOs probably won't benefit from that until certainly later in the year going into 2025. Okay.

Thanks for taking the questions.

Thanks, Brian. All right. Our next question comes from the line of Larry Beagleson from Wells Fargo. Larry, please go ahead. Hi.

This is Charles on for Larry. Thanks for taking the question, and congrats on the nice quarter. I want to just follow up on the LCD again. So I appreciate what you talked about. There's, there's puts and takes before. And so maybe wanted to follow up on, um, to make sure you understand the positives and negatives of that. So on the positive side, I mean, it's by stent incident and maybe the competitive procedures like canaloplasty and gliotomy, maybe some of those stents pick up some of those, but on the negative side, it sounded like we read that stents are only covered as a second line therapy. The language seems to eliminate the stacking of multiple MIGS procedures. Are those the puts and takes you're talking about first there? Can you confirm that? And then I have a follow-up.

Okay. Yeah, Charles, I think first and foremost, anytime you have a policy like this, there's always some inherent ambiguity in it. That's the first line. I mean, I think exactly how the MACs will adjudicate these policy changes is will matter over the course of, you know, the next several years. And that's hard to always know from, you know, the literal reading of a policy that comes out like this. So I think that's one factor that folks have to take into consideration. You know, you referenced obviously some of the adjustments that they're proposing or finalizing as it relates to canaloplasty, some of the shifts on the gonadotomy side. When it comes to the combining of procedures, It's correct that WPS LCD does restrict the clinical decision-making as it relates to the combining of these procedures. And, you know, we think it restricts the options that surgeons have in the fight against what's a multifactorial disease using tools that have complementary mechanism of action. That is one of the puts and takes that have to be considered here and certainly is an offset to any, you know, pickup of share that you might anticipate associated with the restrictions that are being placed on canaloplasty and goniotomy, and something that we're going to take our time to assess from an overall standpoint.

Okay, thank you. And then just a quick follow-up on the LCD, more as it relates to eidos. So, eidos wasn't specifically mentioned in the LCD, but it looks like, I mean, that they're asking for more, just more better data, like they want 24-month published data for a broad label. Can you tell us when Glaucos would have 24-month data published for IDOS? And do you think the Phase IIb data will be good enough to meet qualifications, or do we need Phase IIIb data? And just lastly, it seems like with eliminating the stacking, would that mean a physician would not be able to do an iStent plus IDOS and get covered for it? Thanks for the question.

I'll start, and Tom may want to comment on this one as well. I think as it relates to iDose, first and foremost, it's not covered by this LCD. It's a pharmaceutical, as you know, and at this stage is not within the purview of the LCD that was released by WPS. So I think that's a different conversation entirely, and so we have to take that into consideration there. As you, I think, drew the line to sort of that broader I guess what I would say is I'm not sure that we will have ever, if we're fortunate to get approval as we expect, that we'll ever have launched a product that has more evidence behind it than IDOS will at the time of the commercial launch. You've heard Tom reference on prior calls the sheer number of peer-reviewed publications that we expect to have, the totality of that evidence, the number of patients within it, as well as the long-term evidence that's contained within it. You'll recall that we've already shown multi-year evidence in support of IDOS out of our Phase 2 studies, and ultimately we'll expect to do the same over time out of our Phase 3 studies. So I think the overall evidence there we feel stacks up pretty good against any request that may come from any payer, including the MACs.

Yeah, and I would just add, I mean, think about it. The Phase IIb data we've carried out now, hopefully with some prescience now, after three years. And those three years' data, as we all know, show that 70% of those patients are controlled on the same or fewer meds versus the current standard of care from a topical standpoint, Timolol, which was 46. And so the data is profound, it's robust, and we believe that it will, in any discussions with any payers in the future, will serve us admirably to be able to receive fair and prompt payment.

Great. That helps. And again, congrats on the nice quarter.

All right. Our next question comes from the line of Matthew O'Brien from Piper Sandler. Matthew, please go ahead.

Hey, this is Phil on for Matt. Thanks for taking our questions. For STIRS on glaucoma trends specifically, what was it about August that led to that pronounced seasonality? And how is that seasonality trending in Q4? And as it relates to guidance, what's baked into that sequential step down in revenues? Is it more a function of working down that competitive inventory ahead of these LPDs taking effect? Or is it really more a pausing in front of CMS's final rule?

Yeah, I think, well, first, in the context of the third quarter, what we saw in August was perhaps a new normal in the context of seasonality, but it was a little bit of an aberration versus what we've seen in the last couple of years. I think it was more similar, quite frankly, to what we saw back in 2019 in terms of seasonality than what we've seen in 2020 through 2022. And it really was just a softening of demand. It was across all of our U.S. procedures, glaucoma and corneal health, in a pretty similar fashion. And in both those franchises were offset by strength in both July and September, strength that, to your question, has continued in October. When you think about how that translates into our, you know, 2023, you know, guidance, We try to take into consideration a variety of variables as we exit the year. I've commented on some of them. Clearly, we expect some potential short-term, you know, ordering pattern volatility and headwinds in December within our U.S. glaucoma franchise. That's both because of the potential final LCD effective dates, but also associated, as Tom mentioned in the prepared remarks, with the 2024 final CMS rule and the increased facility fee payments as you enter into 2024. We expect there could be a little bit of disruption as folks hold off on procedures at the end of the year to do them in the first quarter where they'll be paid a more fulsome payment. We also expect some sequential FX headwinds based upon where that's been trending in our international glaucoma business. That could be a little bit of an incremental headwind in the fourth quarter. And we may also experience some potential ordering disruptions at the end of the year in our U.S. corneal health business as we're going to make a variety of moves there operationally this quarter in anticipation of a potential, you know, IDOS launch in early 2024. Several of those operational things that we're going to be putting in place in this quarter can impact areas like customer service and our payer relation team priorities that could create a little bit of a disruption on the cornea side as well.

That's helpful. And then just to give you one that doesn't focus on IDOS, can you speak further about that agreement with Stewart Therapeutics and maybe the timeline for that SP113 drug candidate?

Yeah, I'd be happy to address that. So, Stuart has a very novel compound that's very, it's in a very nascent preparation, but we like the data that we saw in some of the preclinical analysis. And what Stuart has and what we hope to contemplate is a bolus injection that could aid substantially in neuroprotection in glaucoma, which as many of you know is kind of the holy grail. Can you actually preserve the ganglion cells in the back of the eye, given the fact that it's repeatedly being assaulted by the pressure associated with glaucoma? So it is a novel compound, proprietary. It's very early, like I like to say, terribly exciting, terribly early. Stewart Pharmaceuticals uses both. But again, Again, it further validates the fact that we go first. We're making an effort here to break ground in a whole new area of glaucoma treatment, and we're hopeful that this advances into a formable clinical trial.

Thanks so much.

All right. Our next question comes from the line of Joanne Winch. Joanne, please go ahead.

Thank you very much for taking the question, and congrats on the quarter. I'd like to talk about something a little bit less exciting, which is expenses. I did not hear an update maybe on what you think your operating expenses could be. And then as you think about a product launch, this is the time of year that we start thinking about 2024. How do you sort of dovetail preparing and then launching everything that you've got in your pipeline, including iDOS, not just this year but next? Thank you.

Hey, Joanne. This is Alex. I'll start with the operating expense question. And so, I mean, first of all, we were pleased to see the operating expenses for the quarter come in as they did, just shy of $87 million, which was only up modestly 1% sequentially. So we were happy with that. Again, as we've talked about in the past, we've been very, you know, focused on making initial adjustments to our pipeline and anticipation of Eidos and, you know, basically trying to allocate our resources towards that as we prioritize our balance sheet and capital allocation. You asked about the fourth quarter OPEX, and so basically what I would guide you to do at this point is we would expect a modest sequential increase in the fourth quarter to what we saw in this quarter, which is actually in line with what we've seen in the past. Typically, if you want to call it a seasonality standpoint, the fourth quarter tends to rise up a little higher than the third quarter. That should put us for total for the year somewhere around what we had guided to, which was a 10 or a little over 10% increase from last year, again, excluding all of the IPR and decharges.

And then as it relates to, I think, the second part of your question, Joanne, which I'm not sure if that was more towards the expense side or the overall planning, but yeah, we're obviously We've been in product launch planning mode for quite some time. We're now getting into the finer points of what that means from an expense perspective going into next year, how we balance that against other priorities. We do have a lot going on. Thankfully, we think there's a lot of opportunity with each of those. And so we're going to be putting quite a bit behind ICE and Infinite as we enter into 2024 with hopefully more Folsom reimbursement coverage. and then ultimately IDOS on the commercial side while we continue to invest in what we think is a pretty full pipeline of rich opportunities.

So just to push a bit, is a 10% increase annually in 2024 a reasonable starting point, or is it much higher than that given everything else?

I think we'll comment on that, Joanne, when we get to the next quarter's call and we talk about our guidance in 2024 and what the operating expense profile would look like.

That's fair. Thank you.

All right. Our next call comes from the line of David Saxon from Needham. David, please go ahead.

Great. Good afternoon, guys, and thanks for taking my questions. Maybe I'll start with a quick one on iDose. So, you guys obviously completed the inspection and mid-cycle review in August. You mentioned a draft label. know when do you expect to receive that and when when you do is that something you're going to share with the investment community and then aside from that any other milestones to call out before december 22nd yeah david i'm happy to answer that so um we would expect to receive the draft labeling in the near term let's call it the next several days and that begins the process

And that process is the FDA gives their best estimate of what they think the label should be based on the data that they're reviewing. And then ordinarily and routinely, there is provision for response from the company to shape that label or to contest it to the extent that they disagree with the FDA's position. So there'll be a period of negotiation. which will occur prior to the PDUFA date and the final, we hope, favorable FDA clearance. And I think that you can probably respect that that will be something that will be done privately and that we won't share prior to the PDUFA date targeted clearance.

Okay, got it. Thanks. And so I guess no other milestones after that. And then I'll just throw my second question in here. In the document you posted, it looks like you got a pressure flow study starting in the first half of next year. Does this address the concerns the FDA had raised previously? And then, you know, what's your estimate on timing to potential approval of that product? Thanks so much.

Well, I'd be happy to address it as best I can. I mean, I wouldn't, I put it as saying that we've taken a more, I believe, a novel approach in re-looking at how we might evaluate the safety and efficacy of the pressure flow device given our substantial experience in the area. So we've had those discussions. We're finalizing an IDE with the FDA, and we are encouraged that we'll reach a successful conclusion to opening up that study and beginning to study that product in the early part of next year, certainly within the first half. This will be a second bite of the apple, and I think with our informed kind of skill in the arts, we hope to be able to bring it to a successful conclusion I wouldn't comment on date. Too many things we'll enter into when we could potentially commercialize, such as rate of adoption and clinical enrollment, et cetera. But I will tell you that I feel very confident we'll be able to start that study in the first half of next year.

All right. Thank you. And our next question comes from the line of Alan Gong from JPMorgan. Alan, please go ahead.

Hi, thanks for the question. I just had, you know, a quick one on the kind of IDOS timing. You know, I understand you can't really share the details of the mid-cycle review meeting, but, you know, you sound confident on the December timeframe. And I guess, you know, I was wondering relative to kind of your past interactions with the FDA, your past mid-cycle meetings, like, do you feel better or worse roughly in line? I'm just asking because we've, you know, we've seen some FDA, you know, approvals getting pushed out and delayed with, you know, reasons that are kind of not visible to us on this side of the table. So just curious if there's any insight you can provide on what gives you that kind of confidence.

Yeah, I guess I'll be happy to give as best a reasonable assurance as I can. From everything that I'm aware of, given the mid-cycle review and searching for any potential impediments that might come up between now and the final conclusion, I feel that pretty confident that we're going to be able to move towards and we're tracking towards that date for the FDA review of December 22nd.

Got it. And then just another question. You know, I understand that we don't want to talk about 2024 too much now, but when we just think about the growth of the NAICS market kind of x i dose there's clearly been quite a few puts and takes over the last few years you know hopefully 2024 you know there's going to be some bumpiness with the with the lcds and the reimbursement changes but how should we think about stable market growth going forwards thank you yeah alan i'm not sure that 2024 is perhaps the right measurement period because we're obviously going to be making our way through uh all the puts and takes associated with these shifts on the

you know, LCD front from the various MACs. I think we've certainly settled in that aside from maybe some of the moving parts there that we're talking about, you know, an underlying market that continues to grow in a healthy, you know, fashion as MIGS becomes increasingly the standard of care in combination cataract. Our expectation would be that from a macro standpoint that starts to accelerate in the coming years again as we drive our technologies, including iDose and iSEN Infinite, into a much, much larger patient population that's served by the interventional glaucoma approach in standalone patients. So I think, you know, 2024 may be a period where some things settle out in the context of what procedures are being done where, the net effect of which, as we said, we'll comment once we've got, you know, some additional work done on that front. But overall, I think that we're headed to a more favorable environment from a macro standpoint because we're going to be going after a much larger market.

All right. Thank you. And our next question comes from the line of Stephen Lichman from Oppenheimer. Stephen, please go ahead.

Hi, guys. This is Ron for Steve. Congrats on the quarter. I just wanted to ask another question on Dallas City, and it was just short one hopefully since everyone else just asked everything is um i know following the lcds you can think about maybe the net positives since you know your competitors will probably lose much more business or do you guys see also a possible trade-off and as this lcd might shrink the market for maids in general and how do you guys think about this you know new balance

Yeah, Ron, I mean, I think that's at the heart of some of what we were answering earlier is the trade-off here that you have is how much the LCD itself or similar LCDs will restrict or constrain the market over the short term. Again, back to what I just said, I don't think over the long term it'll be as relevant as we're going, obviously, after a much larger patient population, but in the short term, The question is one of share relative to, you know, market growth and those dynamics as they shake out with all the various puts and takes in 2024. You know, I think we're confident that ultimately this should be at least a neutral to slightly positive for our technologies because of the amount of evidence that's behind them and that was validated as a part of this LCD. but it's very difficult at this stage to quantify that, particularly based upon a single LCD that's come out thus far in WPS.

Okay. And just one follow-up, and I think nobody asked about this on IDOS, is obviously you guys can't market it yet, but will you be targeting or trying to promote it as an office-based procedure, or is that something that is not part of the plan?

Ron, I'm happy to address that. And so as we said from the beginning, I think just philosophically, we're agnostic to where the product, the site of service is and where it's used. But we do understand, and there will be some advantages to moving it into an in-office environment. And so what our supposition and proposal will be there is to work with societies, work with the MACs over the course of 2024 into 2025, to create kind of a relative workup scale of what a non-facility payment should be, and then get the MACs on board to be able to reimburse at that level. And so this will be an ongoing process. It is something that we'll be committed to over time. And we want to give surgeons the ability to have the alternative of doing the product within the ASC, which we expect will be the dominant use for some time, into the in-office study. And then I can assure you as well that we continue to work on programs that will continually aid our ability to move into that in-office facility.

Thanks, guys.

All right, thank you. And our next question comes from the line of Anthony Patron from Mizzou Group. Anthony, please go ahead.

Thanks, Gray, and congrats on a good quarter and a good momentum. Maybe just two quick ones, one on iStent Infinite, one on IDOS. On iStent Infinite, you mentioned in your prepared comments here on the quarter that you have a mild to moderate label expansion study going on. And so, you know, how large is that study? When will it be completed? When can we see data on that? And then quickly on IDOS. When we think about label, what should we be thinking about in terms of just duration of implant, right? So, the pivotal study at a three-month primary endpoint, you had a 12-month secondary endpoint that the company, I believe, has data out to five years. So, how should we be thinking about just the range of scenarios on duration of implant for eye dose? Thanks.

Okay. That's the first part of the question, Anthony. And yes, we've begun the clinical study with the iSEN Infinite. And this was our calculus to move this product into the earlier intervention and treatment and to really supplement our whole interventional glaucoma philosophy and program. And so that protocol will consist of both phagic and pseudophagic patients that will fall under the descriptor of mild to moderate open angle glaucoma. So we have a label now that positions Zyston Infinite for patients who failed on medical and surgical prior therapy. This will allow us to open up the ability to use iStin Infinite in the earliest phases of treatment for the treatment of glaucoma. And we think will be a nice both supplemental and combinatorial alternative to the iDose device. A second question, could you repeat that again?

It would be on duration of implant and label for iDose. You have, you know, your primary study at a three-month endpoint. You had a 12-month secondary endpoint. but I believe the company has referenced data on the implant out to five years, so there's a wide range of scenarios there. Is there just any high-level thinking on what the duration of the implant for eye dose could be?

Yes, let me address that again. Happy to. Remember, the primary efficacy endpoint and the basis for our approval will be a three-month determination of the eye dose to show non-inferiority versus topical femoral, and you've seen the data. And I think we can all agree that we have a high degree of confidence that at least we'll have a reasonable argument to assure FDA approval in moving forward. There is no longer term pivotal endpoint for the iDose device. What we've done prior to the FDA pivotal was to conduct this robust phase two data that we carried out for three years. that will be the basis for how we'll approach PEARS for how well this product works longer term. And I think we'll be assured that that data, I think PEARS will be assured with that data that the product does indeed provide substantive coverage for patients all the way out to three years. When you're talking about the five-year data, remember that was a cold set of patients from the Phase IIb study that were exchanged. So 33 patients, where we pulled from that, that we consented to have an exchange of the iDOS device. And it was there that we came up with some pretty pristine data on endothelial cell loss to show that the exchange can be done with reasonable safety and security.

Thank you.

All right. Question comes from the line of George Sellers from Stevens. George, please go ahead.

Hey, good afternoon, and thanks for taking the question. Maybe just one quick one for me, but could you just remind us, thinking back to 2022 and the end of 2021, how your market share of MIGS procedures in the U.S. shifted some reimbursement changes, and do you have a sense for where that share went?

Yeah, George, Joe, I mean, if you look back at our results in 2022 on our U.S. glaucoma franchise, pretty consistently every quarter we were down about 15% on a year-over-year basis. I think that gives you a pretty good sense of, at least in that time period, the share shift that occurred. Beyond that, I don't have the data in front of me in terms of where that went, but I would say that the lion's share of that went to some combination of either canaloplasty procedures or goniotomy procedures depending upon you know surgical preference okay great thanks for that color and i'll i'll leave it at just one thank you all for the time thanks george thanks george all right at this time there are no further questions i'll turn it back over to the company

Okay, so I want to thank all of you again for your time and attention today, and we always thank you for your continued interest and support of Glockos. So with that, goodbye.

That does conclude today's call. Have a pleasant day.