Izervay receives FDA approval for geographic atrophy
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Key takeaways:
- The FDA approved Izervay to treat geographic atrophy.
- Izervay demonstrated statistically significant reduction in geographic atrophy growth in two phase 3 trials.
The FDA approved Izervay, a complement C5 inhibitor, for the treatment of geographic atrophy secondary to age-related macular degeneration, according to a press release from Astellas Pharma.
The approval was supported by data from the GATHER1 and GATHER2 phase 3 clinical trials in which monthly 2 mg injections of Izervay (avacincaptad pegol intravitreal solution) demonstrated a statistically significant reduction (P < .01) in the rate of geographic atrophy growth at 12 months. The slowing in disease progression was seen as early as 6 months, while up to a 35% reduction in progression occurred in the first year of treatment.
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The most common adverse events in the GATHER clinical trials at 12 months were conjunctival hemorrhage in 13% of patients, increased IOP in 9% of patients and blurred vision in 8% of patients.
“We are thrilled to receive FDA approval of Izervay and to offer a new therapy to physicians and appropriate patients in the U.S.,” Pravin U. Dugel, MD, president of Iveric Bio, an Astellas company, said in the release. “Time matters, vision matters and safety matters in this devastating progressive disease.”
Izervay is expected to be available in the U.S. in 2 to 4 weeks.
Perspective
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Geographic atrophy (GA) is a progressive disease that can lead to irreversible vision loss.
Izervay (avacincaptad pegol intravitreal solution, Iveric Bio) was recently approved by the FDA based on the statistically significant GA growth reduction in patients treated with Izervay in both GATHER1 and GATHER2 phase 3 trials.
Vision loss analysis from the GATHER program revealed that patients treated with Izervay had a 56% risk reduction in persistent vision loss compared with sham over 12 months. Izervay was well tolerated in the GATHER program without any cases of clinically significant intraocular inflammation, retinal vasculitis or occlusive retinal vasculitis. Transient IOP increase was reported in 9% of patients treated with Izervay. An increased rate of neovascular age-related macular degeneration was noticed in 7% of patients treated with Izervay compared with 4% in the sham group.
The clinical trial data from the GATHER program gives us confidence in the efficacy and safety of Izervay. However, as with any newly approved drug, we will need to monitor our patients closely to look for any new safety signals once we start to use Izervay in our clinics. Real-world studies done in the U.S. looking at the efficacy and safety will be important to inform the global retina community about the potential of Izervay for the treatment of patients with GA.
The FDA approval of Izervay is great news for the retina community and our patients suffering from GA.
References:
Danzig CJ, et al. Treatment response to avacincaptad pegol by baseline patient characteristics: A prespecified subgroup analysis of the phase 3 GATHER2 study. Presented at: Association for Research in Vision and Ophthalmology meeting; April 23-27, 2023; New Orleans.
Jaffe GJ, et al. Ophthalmology. 2021;doi:10.1016/j.ophtha.2020.08.027.
Kaiser PK, et al. GATHER2 results: Safety of intravitreal avacincaptad pegol in geographic atrophy. Presented at: American Academy of Ophthalmology meeting; Sept. 30-Oct. 3, 2022; Chicago.
Khanani AM, et al. The efficacy of avacincaptad pegol in geographic atrophy: GATHER2 phase 3 results. Presented at: American Academy of Ophthalmology meeting; Sept. 30-Oct. 3, 2022; Chicago.
Perspective
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Izervay represents another step forward in the understanding and treatment of geographic atrophy.
We are well aware of the implication of the alternative complement pathway in the progression of advanced age-related macular degeneration in the form of geographic atrophy, and the retina community is now thankful to have two approaches in treatment of this devasting eye disease, especially in light of the recent safety concerns around Syfovre (pegcetacoplan injection, Apellis Pharmaceuticals).
As we do with any new treatment, intensive monitoring and patient selection are imperative to understanding how we can best maximize patient benefit.
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