Astellas Pharma Inc. has received FDA approval for an expanded U.S. prescribing information (PI) on IZERVAY (avacincaptad pegol intravitreal solution) to treat geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
The announcement comes 2 weeks ahead of the agency’s Feb. 26 target action date and just one month after the FDA accepted Astellas’s revised supplemental new drug application (sNDA).
Hold up … IZERVAY was already approved, right?
Indeed it was. The prescription-based complement C5 inhibitor was first granted FDA approval in August 2023 for the treatment of GA.
- Notably: The significance of its approval was based on it being the first (and still only) GA treatment with a statistically significant reduction in the rate of GA progression at the 12-month primary endpoint (see the supporting clinical data here)
And its original dosing schedule?
The recommended dosage, per the drug’s original PI:
- 2 mg (0.1 mL of 20 mg/mL solution) is to be administered via intravitreal injection to each affected eye once a month (EM) or every other month (EOM) for up to 12 months.
The clinical data for this: Was based on 12-month findings from the phase 3 GATHER1 (NCT04435366) and GATHER2 (NCT04435366) trials.
Now explain this updated labeling.
Essentially: The FDA has cleared IZERVAY to have no limitation on the duration of its dosing, enabling longer-term administration for GA patients.
- What this means: In the words of Astellas: “Eyecare providers (ECPs) and patients have greater flexibility when managing GA.”
Important to note: Astellas previously confirmed to Glance that this labeling extension would include both EM and EOM dosings for IZERVAY.
And the supporting clinical data for it?
That would be 2-year data (12 more months than the original supporting data) from both the GATHER1 and GATHER2 TRIALS that included participants re-randomized in the studies to EM and EOM IZERVAY dosings.
- The crux of that data: IZERVAY continued to slow GA growth, starting at the 6-month mark and continuing through the entire 24-month duration.
- See here for details on those findings, reported mere months after IZERVAY’s initial FDA approval.
How was the therapy tolerated at this 24-month mark versus after 12 months?
As evidenced in the GATHER2 trial, IZERVAY was reported to be “well tolerated,” with:
- 1 case of non-serious intraocular inflammation (IOI)
- 1 case of culture-positive endophthalmitis
- No cases of ischemic neuropathy or serious IOI
- Including retinal vasculitis
Also: The incidence of choroidal neovascularization (CNV) was "slightly increased” between IZERVAY (11.6%) versus sham (9%).
See how this compares to adverse events at the 12-month mark for both GATHER trials.
Nice! What else to know about this?
Astellas also noted that since IZERVAY’s 2023 approval—and through to the end of December 2024—the therapeutic has seen month-over-month growth, with +210,000 vials distributed across the U.S. market.
“Post-marketing safety reporting remains consistent with that observed in the [GATHER] clinical trial program, with no new or significant safety signals identified”—facts that the company said continue to support IZERVAY's safety profile.
And keep in mind: The therapeutic received a permanent J-code in April 2024 (our coverage here).