Clearside Biomedical, Inc. (NASDAQ:CLSD) Q4 2022 Earnings Call Transcript

George Lasezkay: Okay. The comparator arm will be just like it was before we were using faricimab on label, we’re going to be using aflibercept on label. So that’s what I can tell you that there will be the loading doses on label, and then it will be dosed every two months as per its label. And now, and that’s consistent with the draft guidelines from the FDA. So we’ll be loading in both arms, both the investigative arm and in the comparator arm on-label with aflibercept. There should be no difference in the way we look at this. We do — we’ve powered this more for estimation purposes. We’re looking for, mean corrected visual acuity, best corrected visual acuity that we’re trying to see that they’re not this similar, but that we’ve reduced the treatment burden by having fewer maintenance doses compared to now would it be every other month of aflibercept. So in terms of the overall statistical approach, it will be the same as the previous ODYSSEY trial design.

Serge Belanger: Okay. And then second question is kind of a broader strategy one, just curious if you have any plans to explore CLS-AX beyond Wet AMD. I think Tom had previously spoken about diabetic retinopathy. Is it possible to run additional small cohorts to do those evaluations in parallel with the, this ODYSSEY trial?

George Lasezkay: Yes, right now we want to focus simply on the ODYSSEY trial. I think, as Tom has said in the past, and I agree with him, CLS-AX could have interesting potential in diabetic retinopathy, but in, with our resources, we’ve made a decision to focus in a singular fashion on ODYSSEY in Wet AMD patients at this point in time.

Serge Belanger: Okay. Thanks for the updates.

George Lasezkay: Thank you.

Operator: Our next question comes from the line of, I’m sorry, one moment. I apologize. Jon Wolleben with JMP Securities. Your line is now open.

Jonathan Wolleben: Hey, thanks for taking the question. Just a couple.

George Lasezkay: Hi Jon.

Jonathan Wolleben: Hi, George. Couple other follow-ups on ODYSSEY. I know with the prior design you were using the faricimab treatment criteria and wondering if that changes at all with the new comparator? And then also what’s kind of your estimated cost for ODYSSEY as well? Thanks.

George Lasezkay: Let me tell you, when we were still putting, as you might imagine, the guidelines came out. They were actually published on the 27th of February. So we’ve been able to adjust the — make the beginning adjustments to the protocol. When we have a more detailed and a more complete set of information, we’ll let you, we’ll update you on that, but right now we’re still going, still have some stuff that’s preliminary that we’re working through in terms of the actual details, the kind of details that you’re talking about right now. But it — that’s the best I could tell you right now, Jon is we’re making the switch over using faricimab or excuse me, using aflibercept on label as our comparator, but we will be updating once we come out and finalize the new protocol. We’ll give you more detail as it becomes available. You’ve got a follow up to that?

Jonathan Wolleben: Just wondering about the estimated cost for ODYSSEY?

Charles Deignan: Yes. So Jon, this Charlie, we don’t give out the total cost. Again, the protocol is still being finalized, but these Wet AMD studies usually run let’s say 150,000 to 200,000 patients, so you can use that as a guide post.

Jonathan Wolleben: That’s helpful. Thanks, George. Thanks, Charlie.

George Lasezkay: Yes.

Operator: Thank you. One moment for our next question. Our next question comes from the line of Andreas Argyrides with Wedbush. Your line is open.