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Spotlight on IZERVAY®

Ophthalmology 360

This Spotlight Series article is editorially independent content.

Geographic atrophy (GA), the advanced form of age-related macular degeneration (AMD), can cause severe, irreversible vision loss and disability. Although GA lesions often initially appear in the nonfoveal macula, progression typically leads to foveal involvement and permanent central vision loss. Within 7 years of diagnosis, 50% of patients develop bilateral disease, highlighting its substantial impact on quality of life.1,2

IZERVAY®: Protecting Healthy Retinal Cells

Until recently, ophthalmologists had no effective treatment options for GA, leaving a significant unmet need. In 2023, the US Food and Drug Administration (FDA) approved the first therapies for GA, including IZERVAY (avacincaptad pegol intravitreal solution; Astellas Pharma Inc), a complement inhibitor indicated for GA secondary to AMD. Izervay slows disease progression by targeting C5, a key driver of retinal cell death and photoreceptor loss.3-5

Efficacy Data

FDA approval was based on 2 phase 3 clinical trials (GATHER1 and GATHER2), which enrolled more than 700 patients with GA secondary to AMD.

Both were randomized, multicenter, double-masked, sham-controlled studies evaluating monthly intravitreal IZERVAY 2 mg. During the first 12 months, patients were randomized to receive IZERVAY 2 mg or sham. The primary endpoint was the change in GA area, measured by fundus autofluorescence at baseline, 6 months, and 12 months.3

IZERVAY demonstrated a statistically significant reduction in the rate of GA growth through 12 months versus sham (FIGURE 1).3

24-Month Data

IZERVAY continued to slow lesion growth through 24 months in GATHER2. In year 2, patients receiving IZERVAY were re-randomized to monthly or every-other-month dosing, while those in the sham group continued monthly sham.3,5 From baseline to year 2, the annualized mean GA growth rate was 2.23 mm2/year with monthly IZERVAY versus 2.59 mm2/year with sham. Over 2 years, mean GA growth was 4.46 mm2 with monthly IZERVAY versus 5.18 mm2 with sham, representing a 14% difference (see FIGURE 2).3,5

Open-Label Extension Study

In the 18-month open-label extension, patients who completed GATHER2 transitioned to monthly IZERVAY, regardless of prior assignment. Treatment continued to reduce GA lesion growth for up to 3.5 years, with earlier intervention resulting in greater protection of retinal tissue area. The reductions in GA lesion growth are illustrated in FIGURE 3.6

Safety and Tolerability

IZERVAY demonstrated a consistent safety profile through 2 years in the GATHER studies. The most common adverse reactions (≥2%) reported in patients receiving IZERVAY at 12 months were conjunctival hemorrhage (13%), intraocular pressure (9%), and blurred vision (8%).3

Safety findings through 24 months were consistent with those seen at 12 months.3,7 Over 24 months in GATHER2, neovascular AMD or choroidal neovascularization occurred in 12% of the IZERVAY group and 9% of the sham group.3 No cases of retinal vasculitis, ischemic optic neuropathy, or serious intraocular inflammation were reported during the 2-year period.5

Real-world safety data from approximately 600,000 vials of IZERVAY remain consistent with findings from the GATHER studies.3,8

Dosing and Administration

IZERVAY is supplied in single-use vials. The recommended dose is 2 mg (0.1 mL of 20 mg/mL solution) administered by intravitreal injection to each affected eye once monthly (approximately every 28±7 days). The injection should be administered immediately after dose preparation.3

For more information, visit https://www.izervayecp.com/.

References

  1. Danzig CJ, Khanani AM, Kaiser PK, et al. Vision loss reduction with avacincaptad pegol for geographic atrophy: a 12-month post hoc analysis of the GATHER1 and GATHER2 trials. Ophthalmol Retina. 2024;8(11):1052-1060. doi:10.1016/j.oret.2024.04.023
  2. Patel SS, Lally DR, Hsu J, et al. Avacincaptad pegol for geographic atrophy secondary to age-related macular degeneration: 18-month findings from the GATHER1 trial. Eye. 2023;37(37):3551-3557. doi:10.1038/s41433-023-02497-w
  3. Izervay. Package insert. Astellas Pharma US, Inc; 2025.
  4. Boyer DS, Schmidt-Erfurth U, van Lookeren Campagne M, Henry EC, Brittain C. The pathophysiology of geographic atrophy secondary to age-related macular degeneration and the complement pathway as a therapeutic target. Retina. 2017;37(5):819-835. doi:10.1097/IAE.0000000000001392
  5. Khanani AM, Danzig CJ, Heier JS, et al. Avacincaptad pegol for geographic atrophy secondary to age-related macular degeneration: 2-year efficacy and safety results from the GATHER2 phase 3 trial. Ophthalmology. 2025;15:S0161-6420(25)00790-0. doi:10.1016/j.ophtha.2025.12.011
  6. IZERVAY™ (avacincaptad pegol intravitreal solution) showed increased benefit in reducing geographic atrophy progression over time and consistent long-term safety. News release. Astellas Pharma Inc. October 19, 2025. Accessed February 25, 2026. https://newsroom.astellas.com/2025-10-19-IZERVAY-TM-avacincaptad-pegol-intravitreal-solution-Showed-Increased-Benefit-in-Reducing-Geographic-Atrophy-Progression-Over-Time-and-Consistent-Long-Term-Safety
  7. Khanani AM, Patel SS, Staurenghi G, et al. Efficacy and safety of avacincaptad pegol in patients with geographic atrophy (GATHER2): 12-month results from a randomised, double-masked, phase 3 trial. Lancet. 2023;402(10411):1449-1458. doi:10.1016/S0140-6736(23)01583-0
  8. Data on file. Izervay. Astellas Pharma US, Inc.

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