The FDA granted approval based on the results of the GATHER1 and GATHER2 Phase 3 clinical trials in which Izervay met the primary endpoint and reduced the rate of GA growth
A product shot of IZERVAY. (Credit: PR Newswire/ Astellas Pharma Inc.)
Iveric Bio, a unit of Astellas Company, has received the US Food and Drug Administration (FDA) approval for Izervay (avacincaptad pegol intravitreal solution) to treat geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
Izervay is a new complement C5 inhibitor and is said to be the only approved GA treatment.
The FDA granted approval based on the results of the GATHER1 and GATHER2 Phase 3 clinical trials.
Both trials assessed the safety and efficacy of monthly 2mg intravitreal Izervay injection in individuals with GA secondary to AMD.
The rate of GA increase was assessed at three points: baseline, six months, and 12 months.
According to the results, the C5 inhibitor met its primary endpoint in the GATHER1 and GATHER2 clinical trials.
The primary analysis of each registrational trial over a 12-month period revealed a statistically significant reduction in the rate of GA growth in patients treated with Izervay compared to sham.
Additionally, the disease progression was slowed as early as six months, with a 35% reduction in the first year of treatment.
Izervay also reduced the loss of photoreceptors and disease progression as early as six months.
Iveric Bio president Pravin U. Dugel said: “We are thrilled to receive FDA approval of Izervay and to offer a new therapy to physicians and appropriate patients in the US Time matters, vision matters, and safety matters in this devastating progressive disease.
“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.”
GATHER1 and GATHER2 were randomised, double-masked, sham-controlled, multicentre Phase 3 clinical trials.
The primary efficacy endpoints in both studies were as per the GA area calculated by fundus autofluorescence at baseline, six months, and 12 months.
Izervay is expected to be accessible in the US in two-four weeks.
Astellas is evaluating the financial implications of its approval for the fiscal year ending 31 March 2024.
In May this year, Astellas Pharma announced an agreement to acquire Iveric Bio for $5.9bn.