A mere six weeks after obtaining FDA approval, Astellas Pharma is already considering expanding the label for Izervay, an eye injection acquired from Iveric Bio. The latest Phase III results, released earlier this week, have the potential to significantly boost the drug’s usage with 24-month safety and efficacy data.
Izervay garnered FDA approval in early August to treat geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Nevertheless, its usage was initially restricted to a maximum of 12 months, as per the available trial data at that time. Now, Astellas aims to leverage the new 24-month data to seek a label update from the FDA.
The recent Phase III findings bring encouraging news. They demonstrate that the complement C5 inhibitor in Izervay maintains a consistent record of safety over 24 months, with no new safety concerns detected. Astellas has reported a significant reduction in the progression of geographic atrophy (GA) compared to the placebo group at the 24-month milestone.
Astellas’ acquisition of Iveric Bio for $5.9 billion in mid-July included the promising asset Izervay. At the time, the drug was already under FDA priority review, with a PDUFA date set, making it an appealing option for the company.
Izervay faces competition from Apellis Pharmaceuticals’ Syfovre, which received FDA approval for GA treatment in February of the same year. Notably, Syfovre’s label does not impose a time limit on treatment. Nevertheless, shortly after its introduction, Syfovre encountered safety concerns. Apellis pinpointed a specific needle included in select injection kits as a potential culprit, citing “internal structural variations.” The company confirmed eight instances of retinal vasculitis, a severe potential adverse reaction, following the drug’s approval.
Regarding dosing frequency, Izervay’s label suggests an injection every 28 days, whereas Syfovre offers a broader range, with injections recommended every 25 to 60 days. Astellas also noted that Izervay exhibited a comparable decrease in disease progression when administered every other month, offering patients greater flexibility in their treatment schedules.
The GA treatment market has been on the rise, with a valuation of $32.6 billion in the previous year and an expected growth of $68.5 billion by 2029. Analysts have predicted peak annual sales for Syfovre at $2.63 billion, while Izervay’s sales estimates with its current label were more modest at $1.35 billion.
The approval of Izervay and Syfovre put Astellas and Apellis on a direct collision course in the GA treatment market. As the only two treatments for this condition, which affects approximately 1.5 million individuals in the U.S. as age-related macular degeneration progresses, competition in this space is fierce. Analysts anticipate that this field will become a blockbuster pharmaceutical category in the coming years.
The competition between Izervay and Syfovre continues to center around safety as a crucial factor. In July, the American Society of Retinal Specialists expressed apprehensions about eye inflammation, highlighting six occurrences of occlusive retinal vasculitis in patients treated with Syfovre.
Dhaval Desai, Senior Vice President and Chief Development Officer at Astellas’ subsidiary Iveric Bio, stated the company’s intention to present these findings at an upcoming scientific conference and to provide them to regulatory bodies.