m
Recent Posts
Connect with:
Friday / July 19.
HomeminewsIzervay Becomes Second Drug for GA Approved in US

Izervay Becomes Second Drug for GA Approved in US

Izervay, a second drug to treat geographic atrophy (GA), secondary to age-related macular degeneration (AMD), has been approved for use in the United States.

It is expected that avacincaptad pegol (Izervay, Iveric Bio) will be available in the US in the next two to four weeks after being approved by the US Food and Drug Administration (FDA).

A complement C5 inhibitor delivered by intravitreal injection, avacincaptad pegol significantly slowed progression of GA after 12 months of follow-up in two Phase 3 clinical trials. Izervay is the second approved therapy for GA, following approval of pegcetacoplan (Syfovre, Apellis Pharmaceuticals) earlier this year.

In a media release, Iveric Bio said Izervay is the only approved GA treatment with a “statistically significant reduction in the rate of GA progression at the 12-month primary endpoint across two Phase 3 clinical trials”.

It is expected that avacincaptad pegol (Izervay, Iveric Bio) will be available in the US in the next two to four weeks

“We are thrilled to receive FDA approval of Izervay and to offer a new therapy to physicians and appropriate patients in the US,” Iveric Bio President Dr Pravin U. Dugel said.

“Time matters, vision matters, and safety matters in this devastating progressive disease. We would like to thank everyone involved in reaching this milestone and helping us deliver on our commitment.”

The FDA approval was based on the GATHER1 and GATHER2 Phase 3 clinical trials, which evaluated the safety and efficacy of monthly 2mg intravitreal administration of Izervay in patients with GA secondary to AMD.

The rate of GA growth was evaluated at baseline, six months, and 12 months. In each registrational trial, over a 12-month period, the primary analysis showed a statistically significant reduction in the rate of GA growth in patients treated with Izervay compared to sham. Slowing of disease progression was observed as early as six months with up to a 35% reduction in the first year of treatment.

AMD is responsible for half of all blindness and severe vision loss in Australia. It causes progressive loss of central vision, impacting people’s ability to read, watch TV, drive, and recognise faces.