Avacincaptad Pegol Significantly Slows Geographic Atrophy Growth at 24 Months

Credit: Perchek Industries/Unsplash

New positive 24-month topline results from the phase 3 GATHER2 clinical trial indicate the efficacy and safety of avacincaptad pegol intravitreal solution (IZERVAY) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).¹

Announced by Iveric Bio on September 18, a monthly dosing regimen of the complement C5 inhibitor met the primary objective of significantly slowing GA growth, compared to sham, at 24 months. The treatment effect with every-other-month dosing showed a similar reduction in the rate of GA growth compared with sham.

“We are excited about these results, which show that IZERVAY continued to slow the rate of GA growth with a consistent safety profile after two years of treatment,” said Dhaval Desai, PharmD, senior vice president and chief development officer, Iveric Bio. “We look forward to sharing results at a future scientific congress and with regulatory agencies.”

Safety after 2 years of treatment was consistent with the previously reported 12-month data, and no new safety signals were identified by researchers. A single case of culture-positive endophthalmitis and one case of non-serious intraocular inflammation were found, with no cases of occlusive or non-occlusive retinal vasculitis or ischemic neuropathy.

There were no cases of occlusive or non-occlusive retinal vasculitis or ischemic neuropathy. Results showed the rate of choroidal neovascularization was 12% in patients treated with avacincaptad pegol and 9% in those treated with sham.

GATHER2 was a randomized, double-masked, sham-controlled, multicenter phase 3 clinical trial to evaluate the safety and efficacy of intravitreal administration of avacincaptad pegol in 448 enrolled patients with GA secondary to AMD.

The therapy met its primary objective at 12 months when patients were randomized to receive either avacincaptad pegol or sham procedure monthly. In the second year of the study, patients treated with avacincaptad pegol in year 1 were re-randomized to receive either avacincaptad pegol dosed monthly (n = 96%) or every-other-month (n = 93). Those who received sham in year 1 continued with sham in year 2 (n = 203).

The primary 24-month objective was to determine whether, after re-randomization at the 12-month mark, avacincaptad pegol slowed the growth rate of GA in every-month treatment arm compared to sham.

Avacincaptad pegol was approved by the US Food and Drug Administration (FDA) in August 2023, for the treatment of GA secondary to AMD.² The therapy is currently under review by the European Medicines Agency.

In an episode of HCPLive DocTalk from the 2022 American Academy of Ophthalmology Annual Meeting, Arshad Khanani, MD, director of clinical research, at Sierra Eye Associates, discussed findings from the GATHER2 clinical trial and what the research into avacincaptad pegol represents for patients with GA.³

“I think it's a breakthrough in terms of having any treatment for this devastating disease that progresses in 100% of patients 100% of the time and takes their independence away," he said. "I think what we have learned from this trial is to initiate treatment early so we can have a slowdown of this disease."

Listen to the full episode here:

References

1. Iveric Bio Announces Positive 24-Month Topline Results from Phase 3 Study of IZERVAYTM (avacincaptad pegol intravitreal solution) for Geographic Atrophy. Iveric. September 18, 2023. Accessed September 19, 2023. https://ivericbio.com/iveric-bio-announces-positive-24-month-topline-results-from-phase-3-study-of-izervay-avacincaptad-pegol-intravitreal-solution-for-geographic-atrophy/.
2. Kunzmann K. FDA Approves Avacincaptad Pegol for Geographic Atrophy. HCP Live. August 5, 2023. Accessed September 19, 2023. https://www.hcplive.com/view/fda-approves-avacincaptad-pegol-geographic-atrophy.
3. Iapoce C. Arshad Khanani, MD: A Breakthrough in Geographic Atrophy Treatment. HCP Live. October 14, 2022. Accessed September 19, 2023. https://www.hcplive.com/view/arshad-khanani-md-breakthrough-geographic-atrophy-treatment.