With respect to the wet AMD trial results, which in your opinion showed marginal if any benefit, the expert trial investigators for that trial certainly didn't share your view. Below are some of their comments they made on those trial results:
Dr. Pravin Dugel
From a clinician investigator, or from a clinician scientist perspective, a lot of the companies that I know of have looked at efficacy as a bar that's simply too high. Everybody realises the unmet need, but anti-VEGF-A monotherapy is so effective that in order to improve efficacy beyond anti-VEGF-A monotherapy is a daunting task. And they have failed. And I'm really happy that we have a drug here that has the potential to allow us to go beyond that bar that's been set. This is really the first trial that I know of in a very, very long time or historically that has actually improved the efficacy of anti-VEGF-A monotherapy. And that is a much, much more difficult task, a much higher bar than improving durability.
….this is the first time that a different mechanism of action that is complimentary has been shown to be effective and actually better-combined than anti-VEGF-A therapy alone. That's something that, in my mind, is almost the Holy Grail that we've been thinking of for a very, very long time.
…..as a clinician and as a clinician scientist, I'm delighted to be here and very, very excited in this historic day.
….as you may know, I do due diligence for a lot of companies all the time. And, when we do due diligence for a drug, we usually look at the delta. And sometimes what we forget is to say, well what is the lower part of that delta and how does the control arm perform? And as you all know, there are lots of drugs that we can think of that have gone to a larger trial where that delta hasn't been borne out because the control arm may have underperformed. Well, that's something you never have to worry about here, because this is the best performing control arm that I've seen. And for whatever reason, that's what happened. And at the end of the day, if there's a delta with the best performing control arm and the bar is as high as can be, you can be darn sure that that delta is real, and that delta probably will be much greater if the control arm behaves as it should have, or as expected.
…..to be able to have this drug that will actually improve efficacy and possibly for 15 letters, which is three lines, which we really have dreamt about, but have never really come close to achieving, is a monumental achievement and a monumental delta for my patients. If my patients can now live independently, drive, do their chequebooks and so on and so forth, and this drug will push them to be able to do that. It certainly will be used. And it certainly will be very impactful in my clinical practise.
Dr. Tim Jackson
….if you come back to the absolute number, this is a patient population gaining 14 letters, which is huge.
….there was not only improved vision gain but there was reduced vision loss. And I think that will be what plays out if this does get to market, that's what you're looking for.
….the remarkable thing about this is getting such a good result, a positive result, a significant results against an amazing, plus 10 letters in the Lucentis arm. And in the real world we're not going to be seeing 10 letters going into Lucentis. So I think if anything the struggle in the real world will actually push up that Delta significantly because the patients are going to be getting five or six letter gains with Lucentis which gives you much more room to add to the visual gains with a second agent.
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