According to the company, the therapeutic is the only approved GA treatment with a statistically significant reduction in the rate of GA progression at the 12-month primary endpoint across two phase 3 clinical trials.
Astellas Pharma Inc. announced the FDA has approved avacincaptad pegol intravitreal solution (Izervay) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
The company noted in a news release that avacincaptad pegol intravitreal solution, a new complement C5 inhibitor, is the only approved GA treatment with a statistically significant reduction (p < 0.01) in the rate of GA progression at the 12-month primary endpoint across two Phase 3 clinical trials.
The approval, which was announced late Friday, is the second for a drug for geographic atrophy, coming on the heels of pegcetacoplan injection (SYFOVRE, Apellis Pharmaceuticals) in February. Astellas Pharma completed its acquisition of Iveric Bio in July 2023.
According to the company, avacincaptad pegol intravitreal solution met its primary endpoint in the Gather1 clinical trial and the Gather2 clinical trial, both of which were randomized, double-masked, sham-controlled, multicenter phase 3 clinical trials. These trials evaluated the safety and efficacy of monthly 2 mg intravitreal administration of Izervay in patients with GA secondary to AMD.
For the first 12 months in both trials, patients were randomized to receive either Izervay 2 mg or sham monthly. There were 286 participants enrolled in Gather1 and 448 participants enrolled in Gather2. The primary efficacy endpoints in both pivotal studies were based on GA area measured by fundus autofluorescence at three time points: baseline, month 6, and month 12. Safety was evaluated in over 700 patients with GA across the two trials.
Pravin U. Dugel, MD, president of Iveric Bio, an Astellas company, noted it was pleased to receive the FDA’s nod for avacincaptad pegol intravitreal solution and offers a therapy for ophthalmologists and the patients they treat.
“Time matters, vision matters, and safety matters in this devastating progressive disease,” Dugel said in the statement. “We would like to thank everyone involved in reaching this milestone and helping us deliver on our commitment to pioneer transformational therapies for retinal diseases."
According to the company, the FDA granted its approval based on the Gather1 and Gather2 Phase 3 clinical trials, which evaluated the safety and efficacy of monthly 2 mg intravitreal administration of Izervay in patients with GA secondary to AMD. The rate of GA growth was evaluated at baseline, 6 months, and 12 months.
In each registrational trial, over a 12-month period, the primary analysis showed a statistically significant reduction in the rate of GA growth in patients treated with avacincaptad pegol intravitreal solution compared to sham. Slowing of disease progression was observed as early as 6 months with up to a 35% reduction in the first year of treatment.
Moreover, 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 the news release.
“As a C5 inhibitor, Izervay has 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."
GA impacts an estimated 1.5 million people in the US.1 However, approximately 75% of people living with GA in the US are believed to be undiagnosed.2 Without timely treatment, an estimated 66% of people with GA may become blind or severely visually impaired.3
Jason Menzo, CEO of Foundation Fighting Blindness, noted the treatment could go a long way to improve the quality of life of patients diagnosed with GA.
"Geographic atrophy can severely limit people's ability to drive, read, and see the faces of their family and friends,” he said in the release. “This new treatment offers our patient community an important therapeutic option to potentially extend their ability to maintain independence."
Across the Gather clinical trial program, the most common adverse reactions (≥ 5%) reported at 12 months in patients who received Izervay 2 mg were conjunctival hemorrhage (bleeding beneath the clear lining of the eye: 13%), intraocular pressure (increased fluid pressure of the eye: 9%) and blurred vision (8%).
Izervay is anticipated to be available in the US in 2 to 4 weeks.