Clearside Biomedical, Inc. (NASDAQ:CLSD) Q3 2023 Earnings Call Transcript

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George Lasezkay: Thanks for the question. The answer is I don’t know right now because we want to see what the data is that — the data from the ODYSSEY trial will dictate a lot of how we go to the FDA and propose to do a Phase 3 trial. I think the draft guidance, and we’re waiting for the guidance to be finalized, by the way. The draft guidance, the Phase 3 trials are probably going to have to be at least nine months long. They’re going to have to have multiple dosing, and they’re going to have to have some comparison to a standard of care. That we know. Where I think there needs to be some clarification is part of the draft guidelines, and I know a number of companies have probably commented on this, about the dosing of the comparator to be the same dosing as the treatment.

And I think that’s been a question of how to deal with that when what you’re trying to do is dose much less frequently than the standard of care. And we’ve seen ocular go in a direction where they’re saying, well, we’re going to give one dose of aflibercept and one dose of our axitinib. A lot of questions about that trial design, what went into that trial design, what was the thinking and the conversations with the FDA. So, it’s a little early for us to do that. We’re very committed to this current trial design of ODYSSEY as Phase 2b. The way we’ve set it up, we have talked to the FDA about this trial. We did make a change because you may remember one of the things we were going to do is use VABYSMO as a comparator. In view of the draft guidelines, we moved it back to doing aflibercept on label.

We think that makes sense, and we think that’s the thing that is the most relevant is to compare yourself to an on label standard-of-care, and that’s what we think makes the most sense. So, we’ll see what the data comes out of ODYSSEY as the data comes out and as we evaluate that data, that will really guide how we go to the FDA with the proposal for Phase 3.

Operator: Thank you. As we have no further questions in queue at this time. I will hand back to Mr. Lasezkay for any closing remarks he may have.

George Lasezkay: I want to thank everyone for joining us on the call this afternoon. We appreciate your continued interest in Clearside, and we look forward to updating you on our progress. Operator, you may now disconnect the call. Thank you again.

Operator: Thank you. This concludes today’s conference, and you may disconnect your lines at this time. We thank you for your participation.

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