The US Food and Drug Administration (FDA) has approved a second therapy for geographic atrophy (GA), with IZERVAY (avacincaptad pegol intravitreal solution) by Iveric Bio given clearance with its new complement C5 inhibitor.
The 4 August announcement follows the American drug regulator’s approval of SYFOVRE (pegcetacoplan injection), which targets complement C3 and has been developed by Apellis Pharmaceuticals. This became the first and only FDA-approved treatment for GA in February 2023.
In a statement, Iveric Bio’s parent company, Astellas Pharma, said IZERVAY was approved for GA secondary to age-related macular degeneration (AMD). The drug is a complement C5 inhibitor is said to be the only approved GA treatment with a statistically significant reduction (p<0.01) in the rate of GA progression at the 12-month primary endpoint across two Phase 3 clinical trials.
Iveric Bio president Dr Pravin Dugel said the company was “thrilled” to receive FDA approval and offer a new therapy to physicians and appropriate patients in the US.
“Time matters, vision matters, and safety matters in this devastating progressive disease,” he said.
“We would like to thank everyone involved in reaching this milestone and helping us deliver on our commitment to pioneer transformational therapies for retinal diseases.”
The FDA approval was based on the GATHER1 and GATHER2 Phase 3 clinical trials, which evaluated the safety and efficacy of monthly 2 mg 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.
Dr Arshad Khanani, director of clinical research at Sierra Eye Associates, in Nevada, said 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,” he said.
Across the GATHER clinical trial program, the most common adverse reactions (≥ 5%) reported at 12 months in patients who received IZERVAY 2 mg were conjunctival hemorrhage (bleeding beneath the clear lining of the eye: 13%), intraocular pressure (increased fluid pressure of the eye: 9%) and blurred vision (8%).
IZERVAY is anticipated to be available in the US in two to four weeks.
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