Operator: Our next question is coming from Jack Padovano with Stifel. Your line is live.
Jack Padovano: This is Jack calling on for Annabel. So for ODYSSEY, have you powered the study to see non-inferiority at three months or six months? And how are you now accounting for rescue treatment? Because I know that in the OASIS study, there were some patients who were rescued per protocol and there were some others who were rescued because the investigator got a little nervous. So how are you handling that?
George Lasezkay: First of all, let me make a clarifying remark about powering. This trial is not designed to be a non-inferiority trial. It is not designed to be a superiority trial. What we’re doing is just comparing two groups. We have a single dose. What we’re trying to determine is what is the optimal duration of effect that we would then go into establishing a Phase 3 trial that would be powered appropriately either for non-inferiority or superiority compared to standard of care. And we’re still not even really sure what the standard of care might be by the time we get there. We don’t know whether VABYSMO will be included in the standard of care like Lucentis and like EYLEA are currently now. So, we’re just trying to what we’re trying to do is see how far can we go, how much duration can we effect and not be substantially different than the best corrected visual acuity in the comparator group.
So, it’s not really powered. Statistically speaking, it’s not powered for non-inferiority or superiority. What we try to do and you’re right about OASIS, and I was looking at the OASIS data again the other day, and in our two high dose cohorts, so the 0.5 milligram and the 1 milligram. And we’re using the 1 milligram in ODYSSEY. Actually, most of the off protocol or early rescues happen one month in to our highest dose, and it didn’t happen in the lower dose, the 0.5, for some odd reason. I think that was just a matter of small numbers and randomization and what have you. But we were very concerned about that because we thought, well, in some cases, the doctors didn’t have a lot of experience with this, and they pulled the trigger early even though we had very strict criteria.
It was the first time they were using CLS-AX. They may not have known what to expect. A couple of things I would say about off protocol treatments now. Our study design with the three loading doses giving CLS-AX with the second loading dose, we think will help prevent those off protocol, near-term supplemental treatments. Second, this time around, we spent a lot of time in multiple meetings training the site investigators, going over the OASIS data and really training them that the CLS-AX, they don’t have to worry about it too much early on. They need to stick strictly to the criteria that we’ve given them in terms of rescue or supplemental therapy. And I think the increased familiarity with many of these physicians that were in the previous number of them were in the previous OASIS trial.
Now with that increased familiarity with the change in the study design with our loading doses, I think that we’re going to do a very good job of minimizing off protocol early re-treatments.
Operator: [Operator Instructions] Our next question is coming from Yi Chen with H.C. Wainwright. Your line is live.
Yi Chen: In view of the recent FDA draft guidance on wet AMD and the Phase 3 trial design from your competitors. Can you comment on what parts of the ODYSSEY trial design need to be changed in the future pivotal trial?
