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

George Lasezkay: Sure. And remind me of the follow-up, Jon. So I’ll often forget as I’m talking about this. But in terms of BioCryst, we have been working with BioCryst for some time on formulation work in some early preclinical work that encouraged them to move ahead and take the license. That kind of work will continue into next year, as I said in my prepared remarks. We will be collaborative with them probably through next year doing IND enabling studies, but the real handoff and we’ll really probably be at IND, and they will take it forward from there. So, we’re going to work with them on some more animal studies and some fine tuning the formulation. But once that’s done the IND is filed, it’s their molecule and their product to take forward. So, that’s it on BioCryst. So now remind me of the follow-up.

Jon Wolleben: To your comments, it does seem like we’re getting to a critical mass on suprachoroidal news flow and then also in the TKI space and wet AMD, with some readouts coming soon, with expectations there. Can you remind us of what you want to see in ODYSSEY and what you think a competitive profile will be? And how any competitive dynamics may change that before ODYSSEY reads out?

George Lasezkay: Well, I’ve said this before. I said this to you almost a year ago. I remember us sitting together and talking about this. And he said I hope that eye point has good readout on their data. I hope the same thing for ocular, too. I think all three of the companies really are in a position that we’re trying to prove that tyrosine kinase inhibitors have a place. We’re all coming at it slightly differently. There’s two tyrosine kinase inhibitors. Three different ways of administering them. Our Chief Medical Consultant, Retinal Consultant, Tom Ciulla, we still talk to on a regular basis. I always said people knew that tyrosine kinase inhibitors would have a place. It was just a matter of how to deliver them properly.

So I think all of us have that approach, and we’re looking forward to that. I think that we believe in talking to our KOLs and our medical consultants, that if we have maintenance therapy that can guarantee from patients four to six months. We think we have a very good product to be part of the overall treatment paradigm for wet AMD patients. Personally, in our trial, I’m looking — I’m hopeful and very encouraged. I just believe that going to get more than that, we’re going to get at least five to six months, but the data will be the data. But I think any kind of data that supports that the dosing is four to six: months, five to six months, when you look at where the anti-VEGF-As are right now, they can’t really guarantee everybody gets to four months.

They can’t even guarantee everybody gets to three months if you look at the VABYSMO label, and even the high dose IVA label. So we look at this as we believe we’re going to have it this extended duration. We think it’s going to have a place. And the other thing I would say to you is, I keep telling people, I look at the future of wet AMD in particular as more like cancer chemotherapy and that there’ll be different mechanisms of action, different places where the drugs work in the retina. And I think combination therapy is really going to be very important for a number of the patients right now. We know that anti-VEGF only under serves a certain amount of patients. There’s a certain number of patients that don’t respond very well, don’t respond at all, or over time, become somewhat refracted to that single mechanism of action.

So we think there’s a very good place for a different mechanism of action. In our particular case, we think we have a very safe and reliable way to administer. It doesn’t cause any problems in the front of the eye in terms of impairment of vision or anterior chamber toxicity, and certainly no systemic problems. So, we think we have a very good chance to become an important part of treating the wet AMD patient population as long as we’re in that five-, six-month duration.