Iveric Bio Receives FDA Approval for Izervay for Geographic Atrophy

Iveric Bio has received FDA approval for Izervay (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD), parent company Astellas Pharma announced Friday night.

Izervay, a new complement C5 inhibitor, is 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, according to Astellas. 

"We are thrilled to receive FDA approval of Izervay and to offer a new therapy to physicians and appropriate patients in the US. Time matters, vision matters, and safety matters in this devastating progressive disease," Pravin U. Dugel, MD, President, Iveric Bio, said in a company news release. "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."

In an interview with EyewireTV, Dr. Dugel said Izervay will have wholesale acquisition cost of $2,100 per single-dose vial. He added that Iveric will have programs in place so that patients who can't afford it, will have access to it. Those details will be discussed in the upcoming weeks.

Japan-based Astellas Pharma acquired Iveric Bio in May for $5.9 billion. Iveric Bio became a indirectly wholly-owned subsidiary of Astellas.

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, 6 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 6 months with up to a 35% reduction in the first year of treatment. 

Izervay is approved for every month dosing up to 12 months. However, Dr. Dugel said the company will have the 24-month data "in a few weeks." In the 24-month data, the company will have an arm for every other month dosing. He said he hopes that the 24-month data will warrant longer use of Izervay.

"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," said Arshad M. Khanani, MD, MA, FASRS, Director of Clinical Research at Sierra Eye Associates, Reno, Nevada.

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 (13%), intraocular pressure (9%), and blurred vision (8%).

Izervay is anticipated to be available in the US in 2-4 weeks.

The approval of Izervay, which is the second FDA-approved treatment for geographic atrophy, comes just 2 weeks after an ASRS safety committee alerted members of rare cases of retinal vasculitis related to Apellis Pharmaceuticals's Syfovre, which was approved in February. Last week, Apellis stated it has seven confirmed events of retinal vasculitis (4 occlusive, 3 non-occlusive) as determined by Apellis' internal safety committee and external retina/uveitis specialists. Two of these events followed injections in April, two in May, and three in June. There were no events of retinal vasculitis reported by investigators or identified by an independent reading center in the phase 3 clinical trials.