Rishi Singh, MD, presented data from the Phase 3 DERBY and OAKS clinical trials for geographic atrophy at the 2023 Angiogenesis, Exudation, and Degeneration conference.
Rishi Singh, MD, discusses the safety of pegcetacoplan, and what was learned from the 2 Phase 3 clinical trials from his presentation at the Angiogenesis, Exudation, and Degeneration 2023 conference with David Hutton, Executive Editor, Ophthalmology Times®.
Editor’s note: This transcript has been edited for clarity.
I'm David Hutton of Ophthalmology Times. Today, I'm joined by Dr. Rishi Singh, who will be presenting data from the Phase 3 DERBY and OAKS clinical trials for geographic atrophy at the upcoming Angiogenesis, Exudation, and Degeneration 2023. Thanks so much for joining us today. Tell us about your presentation.
Rishi Singh, MD:
Thank you, David, for the invitation. So my presentation is on the safety of pegcetacoplan, and what we've learned from the 2 Phase 3 clinical trials. DERBY and OAKS have been the largest studies conducted in this category of disease. And we have learned a lot from pegcetacoplan's application in these disease states. What my colleague is going to be discussing in our lab is the efficacy, and my presentation focuses merely on the safety of the drug and what we found in those studies.
First and foremost, what we found is that in general, the drug is well tolerated with very low serious safety events across the board. When you look at both of the trials together, there are very low rates of intraocular inflammation or any sort of other concerning condition causing serious adverse events in the eyes.
One of the other additional pieces to this is that when we look at occlusive vasculitis, which we're all heightened by recent episodes of Beovu, we do not see that any of the patients within this study as well. There were patients who had a conversion to devascularization. And we have data to show at least that there was a dose dependent increase in the conversion rates over a 2 year period of time, with those in the every-month group getting a higher rate of conversion versus every-other-month group. And in general, most of those were occult in nature. And patients were continued on treatment through the course of their anti-VEGF therapy, which was all on label and met the endpoints of the study and included within the analysis, the assessments, of the efficacy. So those patients obviously, are there and present and it's of a certainly clinical concern, to clinicians screening for this disease state as they go along with this treatment that they could convert over. Yet, thankfully, it does appear that they do respond well, to the anti-VEGF therapy and do well if we extrapolate from what we saw in the Phase 2 study.
And lastly, I'll say that much has been looked at with regards to intraocular events that occur.Papilledema is one of the events and that was seen, and optic nerve edema in a couple of the patients. And these were truly thought to be due to the study itself, not necessarily due to the drug, but to the natural course of progression of these patients over time. And this is, I think, caveat this to say that this presentation, obviously is 2-year data. It's on a very large population of patients. And so when we make some cross-trial comparisons across other drugs or other sorts of studies, you have to take that into account that this was a longer study with much more patients and a population that was not the same as those other studies as well. So we just need to consider that when we look at all of the efficacy assessments and the safety assessments within these studies.