Glaukos Corporation (NYSE:GKOS) Q3 2023 Earnings Call Transcript

Tom Burns: Yes, 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 will 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 market growth and those dynamics as they shake out with all the various puts and takes in 2024. 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 is behind them, and that was validated as a part of 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.

Unidentified Analyst: Okay. And just one follow-up, and I think somebody asked about this on iDose 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?

Tom Burns: Hey Ron, I’m happy to address that. And so as we’ve 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 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 developing programs that will continually aid our ability to move into that in-office facility.

Unidentified Analyst: Got it. Thanks guys.

Tom Burns: Sure, Ron.

Operator: All right. Thank you. And our next question comes from the line of Anthony Petrone from Mizuho Group. Anthony, please go ahead.

Anthony Petrone: Thanks and congrats on a good quarter and a good momentum. Maybe just two quick ones, one on iStent Infinite, one on iDose. 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 how large is that study? When will it be completed once we see data on that? And then quickly on iDose, 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 iDose? Thanks.

Tom Burns: Okay. To answer the first part of the question, Anthony. And yes, we’ve begun the clinical study with the iStent 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 phakic and pseudophakic patients that will fall under the descriptor of the mild to moderate open-angle glaucoma. So we have a label now that positions iStent infinite for patients who failed on medical and surgical prior therapy, this will allow us to open up the ability to use iStent infinite in the earliest phases — treatment for the treatment of glaucoma. And we think will be a nice both supplementals and combinatorial alternative to the iDose device. Second question, could you repeat that again?