Astellas Pharma’s Izervay, an eye injection treatment, is on a rapid ascent just six weeks after gaining FDA approval. Now, the company has set its sights on expanding the drug’s label based on exciting Phase III results released on Monday, showcasing 24-month safety and efficacy data.
In August, Izervay received FDA approval for treating geographic atrophy (GA) secondary to age-related macular degeneration, but its usage was initially capped at 12 months. Astellas is now armed with compelling 24-month data and plans to approach the FDA for an expanded label.
The latest Phase III results are a triumph for Izervay, revealing that the complement C5 inhibitor maintained consistent safety over 24 months with no alarming new signals. Even more impressively, the drug was reported to have “significantly” slowed the growth of GA compared to a placebo after two years.
Astellas made a strategic move when it acquired Izervay through its $5.9 billion purchase of Iveric Bio in July. This swift acquisition was prompted by Izervay’s FDA priority review status and impending PDUFA date, making it an attractive target for the Japanese multinational pharma.
Izervay’s main competitor, Apellis Pharmaceuticals’ Syfovre, gained FDA approval for GA treatment in February this year, without any time limitations on usage. However, Syfovre faced safety concerns soon after its launch, with eight cases of retinal vasculitis, a potentially blinding side effect. Izervay, on the other hand, boasts a safer track record.
In terms of dosing, Izervay recommends injections every 28 days, while Syfovre suggests a broader range of dosing every 25 to 60 days. Notably, Astellas highlights that Izervay demonstrated a similar reduction in disease progression even when dosed every other month.
The GA treatment market is booming, valued at $32.6 billion last year and expected to surge to $68.5 billion by 2029. Analysts predict Syfovre’s peak annual sales at an impressive $2.63 billion, while Izervay’s current label estimates project annual sales of $1.35 billion. With the potential label expansion, Izervay’s future looks even more promising.