Pravin Dugel: The other questions, Ken. So the conversations with the patient and what this means to me as a clinician, this retrospective data. And as I mentioned to Annabel, this allows me a language of — that I can have with the patient, which is to say when you have a loss of vision of 15 letters or more, that truly changes a patient’s life, that is catastrophic. And to be able to decrease the risk of that is really quite meaningful. So that allows me an avenue to have a very direct and very transparent conversation with the patient. And the other question might be, well, what kind of patient. And I know there’s been a lot of discussion regarding central involving or non-central involving patient, and I just want to clarify that as a clinician.
Look, I believe all patients with geographic atrophy, central involving and non-central involving, early and advanced, all of these patients are eligible. A patient who has central involving geographic atrophy may not progress as quickly as a patient that doesn’t have central involving geographic atrophy. However, a lot of these patients when I was in practice, would come in, their head maybe a little bit tilted, they would be looking from an island of parafoveal photoreceptor cells that they’ve preserved and that’s what would allow them from tripping over furniture and burning their hands on stoves and et cetera. So this drug will be very valuable for those patients. I would argue that those patients would benefit directly from this drug. Now would I enroll a patient like that in a clinical trial?
Probably less likely, because it’s less measurable the delta would be, but that doesn’t mean that the patient wouldn’t have a great deal of benefit from this drug. So the bottom line to my answer is that yes, I think all patients, regardless of how big the geographic atrophy is and where it is unless of course it’s completely burnt out would be eligible for a safe and efficacious drug. In terms of dosing, look, you know that we will have every other month data in our second half of the year, and of the second half of the study, of course. And our first year card turn was on September 7th. So you can do the mathematics there. However, dosing is — in my opinion, is really not going — dosing frequency is not going to be determined by what’s in the label, it’s really going to be determined by what the patient can do.
The conversation is going to go something like this. I’d say, Mrs. Smith, we have a drug that will help you and reduce your chance of having catastrophic vision loss potentially. And to get the best results, you would come in every month as close to every month as you can. And Mr. or Mrs. Smith would then come in as close to every month as he or she can, and that will determine the frequency of treatment, not necessarily what’s written in a label. As far as your question on intermediate macular degeneration goes, look, there’s a very broad range here. Intermediate macular degeneration can be anywhere from one druse to severe intermediate macular degeneration where patients have metamorphopsia changes in color, contrast, sensitivity, et cetera, with large drusen and serous fluid.
We have said publicly that we will not be doing an intermediate macular degeneration study in order to target this patient population. And we believe that having a safe and efficacious drug as we believe ACP has the potential to be will allow us to target that patient population as well. Thank you for your question, Ken.
Operator: The next question comes from Ellie Merle with UBS.
Eliana Merle: Thanks so much for taking the question, and exciting data on vision loss. Maybe can you just comment a little bit in terms of the vision loss definition of 15 letters or greater, and I guess why 15 and whether you looked at other thresholds as well?
Pravin Dugel: The 15 letter milestone or landmark is really traditionally accepted as one that is a devastating amount of vision loss or a significant amount of vision gain, and that’s the doubling of the vision angle and that’s traditionally accepted by regulatory agencies as a important landmark. That’s the reason that we chose to show that and do the analysis in this particular press release. Now having said that, yes, we’ve done sensitivity analyses on several other landmarks as well and we’re convinced because of the sensitivity analysis that we’ve done exhaustively that this trend is a real trend. Again, I want to emphasize that this is a pre-specified safety endpoint, it is a hoc analysis. But yes, we’ve done numerous and exhaustive sensitivity analyses on this and are convinced that this trend is real and that it is impactful.
Eliana Merle: And maybe just in terms of the sensitivity analyses, is that data that we’ll see at the presentation? And just if you can comment if there were any subgroups where you saw perhaps an even greater effect?
Pravin Dugel: Ellie, we have not yet put together that presentation as yet, so I can’t comment on that. We will certainly be showing the data that we’ve released today. And what I can tell you is that we will — we are doing extensive studies based on providing you additional information regarding this functional benefit or potential functional benefit, which will be presented in other major meetings as well.
Operator: The next question comes from Mike Ulz with Morgan Stanley.
Michael Ulz: Congratulations on all the progress as well, and thanks for taking the question. Maybe just a follow-up on the promising vision loss data you provided this morning. Just curious if you’re considering maybe exploring that further in maybe a prospective lead design study?
Glenn Sblendorio: What we’ve shown today is a post hoc retrospective study. And we believe that this is very impactful, very important data that supports the primary endpoint, that’s the reason we presented this. We also believe that it forms a basis for doing future studies that may well be prospective and randomized. Certainly, these are things that we can add on to with future studies. And in all future — all prospective randomized studies are really based on data that you get from encouraging retrospective analyses. So it certainly forms a path and a basis for future studies. Having said that, however, remember our expectation and our goal per our agreements that we have outlined with the regulatory agencies are submission and potential acceptance of our NDA filing based on the 12 month primary endpoint, and that hasn’t changed.
I just want to make sure that we don’t confuse those two things. Our expectation is that the NDA will be reviewed based on our pre-specified agreements that we’ve had with the FDA based on the SPA, based on the breakthrough designation and based on the primary endpoint, which is at month 12.
Operator: The next question comes from Greg Harrison with Bank of America.
Greg Harrison: Are there any thoughts that you can share with us on the breadth via Apellis label and without going into your discussions, maybe just if there is any implications that three year label as a result of what we have seen with them?
Pravin Dugel: It really would be inappropriate for any of us to comment about Apellis other than to say what — and after this maybe Glenn wants to say a few words as well. Other than to say, we are very happy that patients are getting a treatment. It’s long overdue and Apellis and the entire team deserves a great deal of credit for coming across the line here in terms of having a medicine that will help patients. We look forward to seeing how their launch is. We wish them very, very well. But it really would not be appropriate for us to comment on a competitor’s label. Maybe I can pass it to Glenn and see if Glenn has a few words to say as well.
Glenn Sblendorio: And I go back to what we just said in the script. I congratulate them. It’s really exciting to see a company finally be able to have a drug that patients could use, and I think that’s just outstanding. As Pravin said, we wish them luck. We will learn a lot from them. And we are just thrilled that patients and we are thrilled that patients have drug available to them and we’re thrilled to have Apellis
Greg Harrison: And then as you are in the review process here and preparing for US commercialization. Where are you at in the process of potentially finding an ex-US commercialization partner, and what are you looking for in such a partner?
Pravin Dugel: I think with today’s data, we continue to build on the data set and I think all of this is very important to finding a future partner. As we said in the past, we do have a number of meetings in the first half of the year with European regulators, which will give us more guidance. Having data like we presented today, we believe may be helpful in those discussions, so that all continues to move forward. Our objective, as we have said in the past is to focus on the US market and to find help overseas. Today’s just another point of reference or data that will be helpful in that ex-US discussion. So that all continues and we’ll keep you posted on our ongoing discussions with European regulators.
Operator: The next question comes from Eddie Hickman with Guggenheim Securities.
