The results were consistent across every month and every-other-month dosing of Izervay against sham through two years of treatment in 448 enrolled patients
Izervay is approved in the US for the treatment of GA secondary to AMD. (Credit: PR Newswire/Astellas Pharma Inc.)
Astellas Pharma’s Izervay (avacincaptad pegol intravitreal solution) met the primary objective of the Phase 3 GATHER2 clinical trial in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
Izervay dosed every month for two years showed a statistically significant year-over-year reduction of 14% in the mean rate of GA lesion growth. This was at two years from baseline compared to sham, thereby meeting the primary objective of the year two analyses from the trial.
The reduction was observed across every month and every-other-month (EOM) dosing of the drug compared to sham through two years of treatment in 448 enrolled patients.
After a year of monthly dosing, EOM dosing of Izervay led to a 19% decrease in the mean GA growth rate at two years compared to sham.
The benefit of the GA therapy with Izervay compared to sham was seen as early as six months. It increased over the course of two years, and more than doubled over the course of two years in comparison to the first year.
However, the prespecified goal of proving that Izervay lowered the rate of ≥15-letter sustained visual loss during a two-year period when compared to sham was not statistically significant.
Over the two-year period, the drug was well tolerated, but there was one instance of culture-positive endophthalmitis and one case of non-serious intraocular inflammation (IOI).
Iveric Bio SVP and chief development officer Dhaval Desai said: “We are pleased with these new results and look forward to sharing the findings with regulatory health authorities.
“Thank you to all the patients and their families, as well as the eye care professionals who participated in the GATHER2 study.
“Patients are at the centre of all we do, and Astellas is committed to advancing research and developing transformational therapies for people living with retinal diseases.”
Iveric Bio is a subsidiary of Astellas.
In August, the US Food and Drug Administration approved Izervay for the treatment of GA secondary to AMD. The drug is currently under review by the European Medicines Agency for the indication.