Japan-based Astellas Pharma Inc., (TYO: 4503) has announced that it has received new market approval from the US FDA for its drug Izervay (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). This approval reinforces the rationale behind Astellas’ July 2023 acquisition of US biotech Iveric Bio, which was responsible for discovering and developing Izervay, to the tune of USD 5.9 billion.
Izervay: A Complement C5 Inhibitor for GA Treatment
Izervay, a novel complement C5 inhibitor, stands out as the only approved treatment for GA that has demonstrated a significant reduction in the rate of GA progression after a 12-month period of treatment, with a p-value of less than 0.01 in Phase III trials. The drug is administered monthly as a 2mg intravitreal injection, offering a new therapeutic option for patients dealing with this advanced form of dry macular degeneration.
Observed Disease Progression Slowing and Treatment Impact
The slowing of disease progression with Izervay was observed as early as six months into treatment, with up to a 35% reduction in the first year. This advancement in GA treatment is significant, as GA is characterized by the degeneration of large sections of the retina, leading to a loss of function and impacting vision.-Fineline Info & Tech
