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Post hoc data from GATHER1 show the complement inhibitor's 18-month benefit in regions including the central fovea.
New post-hoc analysis from the phase 3 GATHER1 clinical trial showed investigative geographic atrophy (GA) therapy avacincaptad pegol (Zimura) provides GA lesion growth reduction in the 5 standardized regions surrounding and including the central foveal area of the retina.
The findings, presented at the Angiogenesis, Exudation, and Degeneration 2022 Meeting this weekend, support the observed 2 mg intravitreal (IV) dose of avacincaptad pegol in eyes with GA over 18 months.
Presented by investigator Glenn J. Jaffe, MD, the Chief of Division of Retinal Ophthalmology at Duke University School of Medicine, the new analysis sought to observe the pattern of GA growth reduction relative to the natural history of the chronic retinal disease among patients previously treated with avacincaptad pegol in the GATHER1 trial.
Previously published data from the prospective, randomized, double-masked and sham-controlled GATHER1 trial showed 2 different monthly dose regimens of avacincaptad pegol were associated with up to a 28% reduction in GA lesion growth over 12 months, with favorable safety profiles.
Further trial data at 18 months—reported by Veeral S. Sheth, MD, MBA, Director of Clinical Research at the University of Retina and Macula Associates, at the Association for Research in Vision and Ophthalmology (ARVO) 2021 Meeting last June—showed the intravitreal injection therapy provided up to 30% reduction in GA lesion growth over 18 months, again with good tolerability and safety.
Now, these newest findings from GATHER1 included data from 146 eyes with Heidelberg FAF and optical coherence tomography (OCT) screening from trial visits. Among them, 47 eyes were treated with 2 mg avacincaptad pegol and 79 with sham therapy.
Jaffe and colleagues defined the central foveal region as the 2 mm diameter center circle of the retina, while 2-8 mm non-central regions constituted the superior, nasal, inferior and temporal regions.
Indeed, the investigates observed a decrease in GA growth with the investigative therapy versus sham in all regions of the retina, including the central fovea, over 18 months. Decreases for each region versus sham, consistent with natural disease history, were as follows:
While the study warrants further long-term assessment of the impact of avacincpatad pegol on the central foveal region, Iveric experts and leadership expressed satisfaction and excitement for the new post-hoc findings.
“We believe the observed pattern of reduction in GA growth is consistent with the natural history of the disease and recent clinical trial results in which complement inhibition has been observed to be associated with a greater reduction in GA growth in patients with non-foveal GA, which is known from the natural history to be faster progressing than foveal-involving GA,” Dhaval Desai, PharmD, Chief Development Officer of Iveric, said in a statement. “This analysis supports our expectation that we would see a greater reduction in growth away from the foveal center, reflecting the circumferential growth pattern typical for GA patients.”
Previously, HCPLive spoke with Sheth on the potential utility of avacincaptad pegol for the treatment of patients with GA. Along with describing the mechanistic benefit of complement inhibitors for patients with the chronic retina disease, he explained the current state of available treatment for these assessed patients.
“We have nothing for these patients—they suffer this vision loss,” Sheth explained. “This time point feels a lot like what it felt like 15 years ago when we were getting our first anti-VEGF therapies and saying to people for the first time, ‘Hey, we can actually alter the course of your disease in a meaningful way.’”
The study, "Evaluation of GA Growth Parameters and Impact on Foveal Progression: Post Hoc Analysis of the GATHER1 Trial," was presented at AED 2022.