Iveric Bio, an Astellas Pharma Inc. company, announced the release of positive 24-month topline data from the phase 3 GATHER2 clinical trial assessing IZERVAY (avacincaptad pegol intravitreal solution) 2 mg for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
Refresh me on IZERVAY.
Developed under the name ACP/Zimura, IZERVAY (pronounced EYE-ZER-VEY) is a complement C5 inhibitor formulated to slow GA progression.
Per the prescribing information, a 2 mg (0.1 mL of 20 mg/mL solution) is to be administered via intravitreal injection to each affected eye once a month for up to 12 months.
Hold up … wasn’t it just approved?
Indeed it was … the FDA granted IZERVAY approval in August 2023 as the first and only GA treatment with a statistically significant reduction in the rate of GA progression at the 12-month primary endpoint.
There’s already trial data on it, right?
Yup! Twelve-month data from the GATHER1 (NCT02686658) and GATHER2 (NCT04435366) phase 3 trials (n = 733, combined) found then-ACP met its primary endpoints, which were based on GA area measured by fundus autofluorescence (FAF) at three timepoints: baseline, 6 months, and 12 months.
The mean rate of growth in the GA area from baseline to month 12, based on data, was slowed by 35% in GATHER1 and 18% in GATHER2.
See here for additional data.
Now update me on this 24-month trial data.
In year 2 of the GATHER2 trial (n = 448), IZERVAY-treated patients were re-randomized to be administered IZERVAY on a monthly (EM, n = 96) or every-other month (EOM, n = 96) basis.
Sham-treated patients (n = 203) from year 1 continued to be administered sham in year 2.
And the objective?
Per Iveric, to determine whether (after re-randomization), IZERVAY continued to slow GA growth rate for EM-treated patients vs sham-treated patients.
And the data?
Topline results indicated that an EM dosing regimen for IZERVAY met its primary endpoint in significantly slowing GA growth (vs sham injections).
Further, an EOM dosing regimen resulted in a similar reduction in GA growth rate (vs sham), according to Iveric.
What about safety?
Iveric reported that, overall, 24-month safety was consistent with the previously-reported 12-month data—with no new safety signals noted.
Give me specifics.
One case each of culture-positive endophthalmitis and non-serious intraocular inflammation (IOI) were observed.
Per the company, the rate of choroidal neovascularization (CNV) was 12% and 9% in patients treated with IZERVAY and sham, respectively.
Significance?
This latest longer term data further supports IZERVAY's safety and efficacy in treating its target patient population.