IVERIC bio, Inc. (NASDAQ:ISEE) Q4 2022 Earnings Call Transcript

Eddie Hickman: Just a few from me. Throughout GATHER2, you were able to provide updates on the injection fidelity, which gave you confidence on meeting that primary endpoint. Are you able to give any color on how that’s tracking so far in the second year?

Pravin Dugel: What I can tell you is as of now, we haven’t guided to the numbers as yet, but I can tell you that we’re very, very pleased with the way that that’s tracking. We’ve got a fantastic clinical operations team and they’re very, very hard at work to make sure that all these patients are retained and that the injection fidelity is as high as possible. So we haven’t given guidance as to the numbers as yet. But I can tell you that we’re doing very well and are very pleased with the ongoing process.

Eddie Hickman: And then really interesting visual acuity data that you presented. I’m curious if that’s something you can share with the FDA as part of your back and forth that you get with your breakthrough designation without needing to file any additional amendments, just to sort of show them the confidence that you’re seeing on that functional endpoint throughout the early part of the review?

Pravin Dugel: Eddie, as you know, we’re under review at this time. We’ve said publicly that we are very pleased with our interactions with the FDA. We found them as expected to be extraordinarily collaborative. And we feel that the questions that are going back and forth are exactly the right questions that we would like and that we are doing we believe everything the way that we — that the FDA would like us to. So we’re very, very happy with the interactions. But other than that, we certainly don’t want to be publicly commenting on any details regarding the discussions that we’re having with the FDA. But thank you for your question.

Operator: The next question comes from Kambiz Yazdi with Jeffries.

Kambiz Yazdi: Can you provide us any more color on your interactions with the FDA on intermediate AMD? And then I may have a few more follows after that.

Pravin Dugel: What we’ve said publicly is that with the interactions that we’ve had we will not be doing an intermediate AMD study as we’ve announced, I think, some time ago. And we feel that we’ll be able that — to target intermediate AMD without doing a specific study for intermediate AMD, because this is considered a continuum of disease. We said that publicly. And other than that, we have not guided as to any further details regarding our interactions with the FDA.

Kambiz Yazdi: And then, if ACP is approved in August, what would be the general timeframe for receiving a permanent J code for ACP?

Pravin Dugel: Chris, maybe I can pass that question on to you.

Chris Simms: So following our August PDUFA date, it’s an important question by the way. So we plan to file, at the first quarterly opportunity, which again, based on the August PDUFA date, would be the 2nd of October, would be the first opportunity to file for the permanent J code. And then following that timeline, we would expect to get the permanent — and hope to get the permanent J code in the early second quarter of €˜24.

Kambiz Yazdi: And one final one, just to put a final point on every other month dosing. If the data are positive from year two of GATHER2, would you pursue every other month dosing for ACP, would this have to come as sNDA?