Clinical Trials at the Summit 2023: Update on visual function data from DERBY and OAKS Studies

Video transcript

Editor’s note: Transcript lightly edited for clarity.

David Hutton: I'm David Hutton of Ophthalmology Times. The Clinical Trials at the Summit program is being held this year in Park City, Utah. I'm joined today by Dr. Caroline Baumal, whose presentation is titled, Update on Visual Function Data from DERBY and OAKS Studies. Thanks for joining us for this update. Tell us about your presentation.

Caroline Baumal, MD: Thank you, David. It's great to be here. I'll be presenting at Clinical Trials at the Summit on pegcetacoplan treatment for geographic atrophy. This is the first FDA approved therapy for geographic atrophy, as of February 2023. Prior to my talk, Dr. Dilsher Dhoot will be presenting on the efficacy of pegcetacoplan for geographic atrophy, and he'll be highlighting the phase 3 DERBY/OAKS trial results. Of note, he'll be highlighting some of our recent data, evaluating patients with non subfoveal lesions and highlighting how the reduction in growth of geographic atrophy was 23% at 12 months, and 22% at 24 months. He'll also be reviewing RPE and retina self preservation in pegcetacoplan treated eyes compared to sham.

This will be followed by my talk, and I'll be reviewing some of the AI data that supports the use of pegcetacoplan for geographic atrophy. Of note, there was reduction and photoreceptor and RPE cell loss in pegcetacoplan-treated eyes compared to sham. Then I'll be following this with some of our functional data that demonstrated that pegcetacoplan was associated with slower vision loss and better quality of life measures in patients with geographic atrophy lesions 250 microns or greater from the foveal center. So, this is really exciting that we have this functional benefit shown in patients with pegcetacoplan, and this will add to data that we can give to our patients as well as retina physicians in treating these patients.

David Hutton: Ultimately, what's the next step for your research?

Caroline Baumal, MD: We have such a wealth of data from the DERBY and OAKS studies. Over 1200 patients were treated, making this the second largest phase 3 trial study for geographic atrophy. As well, patients with heterogeneous GA lesions were included, over 60% of patients in the trial had subfoveal lesions, and I think that this makes for a lot of scientific information that we can evaluate and really get into the nitty gritty about to figure out what baseline characteristics are predictive of patients with the best responses; who will benefit from these treatments; how can we help physicians identify patients early who will have the most benefit? I mean, there's so many questions, and my colleagues asked me all the time, I have them all written as a huge list of things that we can look at. So, I think it's [a] really exciting time for geographic atrophy, and we didn't have a treatment for this in the past. And now, we have something that we can work with to understand the disease better and treat our patients appropriately.

David Hutton: And ultimately, what can this all mean for ophthalmologists and the patients they treat?

Caroline Baumal, MD: Well, I think we're changing the treatment paradigm for geographic atrophy. For many years, we had access to medications for neovascular AMD, and, but we were stumped by geographic atrophy. And it's not that people haven't tried over the years. There have been, you know, all of the previous attempts led to this success. So now, we have an opportunity to treat patients better and to change the course of this disease. I think that that is something that should not be missed. And you know, all of this, all of this technology, everything that we learn, will help us understand geographic atrophy better.