Results from Iveric Bio’s Phase III trial demonstrated that over a two-year period, IZERVAY™ (avacincaptad pegol intravitreal solution) reduced geographic atrophy (GA) lesion growth as early as six months.
IZERVAY ™ (avacincaptad pegol intravitreal solution) induced a year-over-year reductions in the rate of geographic atrophy lesion growth in patients with geographic atrophy secondary to age-related macular degeneration (AMD) in a Phase III trial, Astellas Pharma has announced.
The findings presented at the American Academy of Ophthalmology (AAO) 2023 Annual Meeting, revealed that the treatment continued to reduce the rate of geographic atrophy lesion growth for both every month and every-other-month dosing compared to sham treatment over two years in geographic atrophy secondary to age-related macular degeneration (AMD).
IZERVAY (avacincaptad pegol intravitreal solution) Phase III study – key results
According to Astellas, when dosed every month over a period of two years, IZERVAY demonstrated a statistically significant year-over-year reduction of 14 percent in the mean rate of geographic atrophy growth at two years from baseline versus sham.
When administered every other month, the data showed that over one year, IZERVAY enabled a 19 percent reduction in the mean geographic atrophy growth rate at two years compared to sham.
Effiacy benefit with IZERVAY versus sham was observed as early as six months, and this continued to increase over the two-year period. This benefit was shown to more than double over two years compared to year 1.
“These exciting results demonstrate year-over-year reductions in the rate of lesion growth in patients treated with monthly and every-other-month dosing compared to sham. The treatment benefit was observed as early as six months and continued to increase over time.
[The Phase III data suggests that] IZERVAY is an effective and safe treatment option for patients with geographic atrophy”
“The safety profile over two years was consistent with year 1, with no new safety signals identified. These results further validate that IZERVAY is an effective and safe treatment option for patients with geographic atrophy,” remarked Dr Arshad Khanani, MA, FASRS, Director of Clinical Research at Sierra Eye Associates, US.
Dhaval Desai, Senior Vice President and Chief Development Officer of Iveric Bio, an Astellas Company, confirmed in Astellas’ statement that results from the Phase III trial will be shared with regulatory health authorities.
The US Food and Drug Administration (FDA) approved IZERVAY in August 2023, for geographic atrophy secondary to AMD. Iveric Bio’s avacincaptad pegol intravitreal solution is currently being reviewed by the European Medicines Agency (EMA) for approval in the EU .