IZERVAY is expected to be available in the United States within 2 to 4 weeks.
On Friday, Astellas Pharma Inc. and its subsidiary Iveric Bio announced the FDA approved avacincaptad pegol intravitreal solution (IZERVAY) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Astellas Pharma acquired Iveric Bio in July.
In a news release, Astellas Pharma stated that avacincaptad pegol intravitreal solution, 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 2 Phase 3 clinical trials.1
The biopharma company's vacincaptad pegol intravitreal solution met its primary endpoint in the GATHER1 (NCT02686658) clinical trial and the GATHER2 (NCT04435366) clinical trial. Both were randomised, double-masked, sham-controlled and multicentre Phase 3 clinical trials. The trials evaluated the safety and efficacy of monthly 2 mg intravitreal injection of IZERVAY in patients with GA secondary to AMD.
For the first 12 months in both trials, patients were randomised to receive either avacincaptad pegol intravitreal solution 2 mg or sham monthly, the company stated. There were 286 participants enrolled in GATHER1 and 448 participants enrolled in GATHER2.
In both studies, the primary efficacy endpoints were based on GA area measured by fundus autofluorescence. The GA growth rate was evaluated at 3 time points: baseline, month 6 and month 12. Safety was evaluated in over 700 patients with GA across the two trials.
According to the company, the FDA granted its approval 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.
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 avacincaptad pegol intravitreal solution 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.
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%).
Pravin U. Dugel, MD, president of Iveric Bio, noted the company was pleased to receive FDA approval for its avacincaptad pegol intravitreal solution.
"Time matters, vision matters and safety matters in this devastating progressive disease,” Dugel said in the news release.1 “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."
Arshad M. Khanani, MD, MA, FASRS, director of Clinical Research at Sierra Eye Associates, Reno, Nevada, also spoke to the promising potential of avacincaptad pegol intravitreal solution.
“Geographic atrophy has a devastating impact on patients' lives and can lead to irreversible vision loss,” Khanani said.1 “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."
Iveric Bio's solution is the second approval for a drug aimed at geographic atrophy. SYFOVRE, the pegcetacoplan injection from Apellis Pharmaceiticals, received approval in February.
Khanani added, "The FDA approval of IZERVAY is great news for the retina community and our patients suffering from GA."
IZERVAY is expected to be available in the US within 2 to 4 weeks.