Charles Wykoff, MD, PhD, spoke with Ophthalmology Times about the GALE study data at one year looking at pegcetacoplan for the management of geographic atrophy at this year's American Academy of Ophthalmology meeting.
Charles Wykoff, MD, PhD, spoke with Ophthalmology Times about the GALE study looking at pegcetacoplan for the management of geographic atrophy at this year's American Academy of Ophthalmology meeting.
Editor's note - This transcript has been edited for clarity.
Hi, I'm Charles Wykoff, a retina specialist in Houston, Texas, and this year at AAO 2023, we are presenting the GALE data for the first time at one year. So GALE is the long-term extension study looking at pegcetacoplan for the management of geographic atrophy. Remember that the GALE trial began at the end of DERBY and OAKS. So DERBY and OAKS were the preceding Phase III clinical trials looking at the management of pegcetacoplan compared to sham monthly or every other month dosing for pegcetacoplan, and the Phase II trials are what led to the FDA approval of pegcetacoplan for the management of geographic atrophy earlier this year, 2023. So GALE is ultimately going to be a 3-year extension study. So we'll, ultimately, we'll have 5 years of continuous dosing information with pegcetacoplan for geographic atrophy, an incredibly rich data set. And this year, for the first time, we have 1-year data out of GALE so that's 36-month total continuous treatment with pegcetacoplan. The key efficacy finding is that there's increasing treatment effect sizes over time. And we expected to see this, based on what we saw in the Phase III clinical trial data, which is that the effect size, it gets larger over time. And at the end of 1 year in GALE, in the total population, we're seeing between 24 and 35% slowing of geographic atrophy lesion growth depending if you're every other month or monthly dosing. That effect size is magnified, as you would expect, among patients with nonsubfoveal geographic atrophy at baseline. In other words, patients that had foveal sparing, those tend to have faster growing lesions. And among that population, slowing of geographic atrophy growth was in the low 40%. So 42% with monthly dosing, quite substantial slowing of progression in that third year.
That's the efficacy data. From a safety perspective, very consistent safety signal from what we saw in the preceding Phase III trials, ischemic optic neuropathy in one patient, intraocular inflammation between 1 and 4% of patients over time, and then wet AMD being the most common thing that you might see in your clinical practice if you're using pegcetacoplan. And that's up to about 19.5% cumulative risk of developing wet AMD in the monthly arm, versus less than 9% in the every other month arm, cumulatively, through 3 years.
And then finally, to address the the concern of severe vision loss and vasculitis: this has not been seen in the clinical trials, but has been reported in the real-world usage. So again, summarizing the GALE data which is the 1 year first year of the long term extension study looking at pegcetacoplan in the management of geographic atrophy following DERBY and OAKS. Thank you.