Second Drug for Geographic Atrophy Gets Green Light From FDA

The FDA approved avacincaptad pegol (Izervay) for geographic atrophy secondary to age-related macular degeneration (AMD), Iveric Bio announced.

A complement C5 inhibitor, avacincaptad pegol significantly slowed progression of geographic atrophy after 12 months of follow-up in two phase III clinical trials. The agent is the second approved therapy for geographic atrophy, following approval of pegcetacoplan (Syfovre) earlier this year.

“Geographic atrophy [GA] has a devastating impact on patients’ lives and can lead to irreversible vision loss,” said Arshad Khanani, MD, of Sierra Eye Associates in Reno, Nevada, in the company announcement. “As a C5 inhibitor, Izervay has shown to slow GA progression by targeting the source of retinal cell death and may preserve the upstream benefits of the complement system. The FDA approval of Izervay is great news for the retina community and our patients suffering from GA.”

Geographic atrophy affects an estimated 1.5 million people in the U.S. and is thought to be undiagnosed in a majority of cases. In the absence of treatment, two-thirds of patients with geographic atrophy may develop severe visual impairment or blindness.

“Geographic atrophy can severely limit people’s ability to drive, read, and see the faces of their family and friends,” said Jason Menzo, CEO of Foundation Fighting Blindness. “This new treatment offers our patient community an important therapeutic option to potentially extend their ability to maintain independence.”

Support for the approval came from the phase III randomized, sham-controlled GATHER 1 and GATHER 2 trials. Both trials showed slowing of geographic atrophy progression at 6 and 12 months, reaching as much as a 35% difference compared with the control group at 12 months (P<0.01).

Adverse reactions occurring in ≥5% of patients treated with avacincaptad pegol consisted of conjunctival hemorrhage (13%), increased intraocular pressure (9%), blurred vision (8%), and neovascular AMD (7%), according to the drug’s prescribing information. It is contraindicated in patients with ocular or periocular infections, or with active intraocular inflammation.

Avacincaptad pegol is administered via an intravitreal injection in the affected eye. The recommended dose is 2 mg (0.1 mL of 20 mg/mL solution) given monthly for up to a year.

According to Iveric Bio, the drug should be available in the U.S. within 2 to 4 weeks. Avacincaptad pegol was also referred to as Zimura during development.

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