Iveric Bio releases 24-month topline results from Phase 3 study of avacincaptad pegol intravitreal solution (IZERVAY) for geographic atrophy

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Astellas Pharma Inc. announced positive 24-month topline results from the Phase 3 GATHER2 (NCT04435366) clinical trial evaluating the efficacy and safety of avacincaptad pegol (ACP) intravitreal solution (Izervay, Iveric Bio), a complement C5 inhibitor for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

According to the company, the topline results demonstrated that the ACP intravitreal solution monthly dosing regimen met the primary objective to significantly slow GA growth compared to sham at 24 months. Additionally, the treatment effect with the every-other-month dosing regimen for IZERVAY showed a similar reduction in the rate of GA growth versus sham.

ACP is a novel complement C5 protein inhibitor. Overactivity of the complement system and the C5 protein are suspected to play a critical role in the development and growth of scarring and vision loss associated with GA secondary to AMD. By targeting C5, ACP has the potential to decrease activity of the complement system that causes the degeneration of retinal cells and potentially slow the progression of GA.

Overall, safety after 24 months of treatment was consistent with previously reported 12-month data, with no new safety signals identified. There was one case of culture-positive endophthalmitis and one case of non-serious intraocular inflammation. There were no cases of occlusive or non-occlusive retinal vasculitis or ischemic neuropathy. The rate of choroidal neovascularization (CNV) was 12% in patients treated with IZERVAY and 9% in those treated with sham.

According to Dhaval Desai, PharmD, Senior Vice President and chief development officer, Iveric Bio, an Astellas company, said the company was happy with the results.

“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. We look forward to sharing results at a future scientific congress and with regulatory agencies.”

ACP intravitreal solution was approved by the FDA last month for the treatment of GA secondary to age-related macular degeneration (AMD) and is currently under review by the European Medicines Agency.

According to the company, GATHER-2 was a randomly, double-masked, sham-controlled, multicenter Phase 3 clinical trial to evaluate the safety and efficacy of intravitreal administration of avacincaptad pegol (ACP) in 448 enrolled patients with GA secondary to AMD.

The news release noted ACP met its primary objective at 12 months, for which patients were randomized to receive either ACP or sham procedure monthly. In year 2 of the study, patients treated with ACP in year 1 were re-randomized to receive either ACP dosed monthly (EM, n = 96) or every other month (EOM, n = 93); patients who received sham in year 1 continued to receive sham in year 2 (n = 203). The primary objective at 24 months was to demonstrate whether, after re-randomization at 12 months, ACP slowed the GA growth rate (slope) in the EM treatment arm compared to sham.

Arshad M. Khanani, MD, MA, FASRS, director of clinical research at Sierra Eye Associates, Reno, Nevada, lauded the opportunity afforded by avacincaptad pegol intravitreal solution.

“Geographic atrophy has a devastating impact on patients’ lives and can lead to irreversible vision loss,” Khanani said in a recent interview. “As a C5 inhibitor, Izervay has been shown to slow GA progression by targeting the source of retinal cell death and may preserve the upstream benefits of the complement system. The FDA approval of Izervay is great news for the retina community and our patients suffering from GA.”