Astellas Gets Life-Changing FDA Approval for Iveric in Treating Geographic Atrophy

Iveric Bio’s cutting-edge intravitreal avacincaptad pegol is now officially available as Izervay, after it just received the FDA’s stamp of approval. This groundbreaking medication is set to revolutionize the treatment of geographic atrophy secondary to age-related macular degeneration.

Last month, after Astellas Pharma snapped up the New Jersey biotech for a whopping $5.9 billion, the regulatory authorities recently gave it the thumbs up – sealing the deal and giving the two big players a major victory.

Friday’s historic approval of Izervay marks a major milestone in the fight against Geographic Atrophy- a disease that can cause significant irreversible visual impairments. Astellas’ announcement confirms the results of two Phase III studies, confirming Izervay to be the first treatment to significantly slow down GA progression in 12 months! Iveric Bio President Pravin Dugel has expressed his excitement at the news, and has highlighted the offering of a novel treatment option to physicians and patients across the United States.

Unveiled and crafted by Iveric, Izervay is a special intravitreal eye injection that inhibits the function of complement C5 protein. By avoiding the breakdown of C5, this injection also ceases additional pathways, including the formation of the membrane attack complex and inflammasome. Together, these blockages contribute to the diagnosis of the age-related eye condition known as Geographic Atrophy (GA).

Through a prospective, randomized and sham-controlled pivotal Phase II/III trial (GATHER1), Iveric was able to test the therapeutic potential of Izervay’s mechanism of action. Remarkably, it showed that at the 2-mg dose level, GA growth was slowed by 27.4% over 12 months. Even more remarkable was the 4-mg dose, providing a 27.8% slowing of growth compared to the sham control. Both dose levels were unbeatably effective.

In September 2022, the company delightedly shared the results of its Phase III GATHER2 study, which demonstrated that after 12 months of treatment, patients administered with Izervay experienced far slower growth in GA area, when compared to those receiving the sham controls. This exciting news exceeded the study’s prespecified primary endpoint!

The GATHER program concluded that Izervay had a manageable safety profile. In terms of side effects, most patients observed bleeding beneath the clear lining of the eye, while others experienced increases in intraocular pressure or blurred vision. In general, Izervay was well-tolerated.

Izervay stands out for its commitment to safety: in its label, it contains warnings about retinal detachment, increased intraocular pressure, neovascular age-related macular degeneration and eye infections. Unlike many other medications, Izervay does not require a boxed warning – so you can trust that it’s a safe and reliable choice!

Astellas and Iveric anticipate a swift arrival of Izervay to the US market – only six short months behind Apellis’ Syfovre (pegcetacoplan). With expected availability in two to four weeks from now, you won’t have to wait long to get your hands on this much-anticipated drug.

Intravitreal administration of two treatments are now available to help slow lesion growth. While these treatments disrupt the complement cascade, the efficacy of visual function isn’t yet known. It will be important to continue to monitor these treatments for long-term efficacy.

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