Profile
General Information
Izervay (avacincaptad pegol intravitreal solution) is a complement C5 inhibitor.
Izervay is specifically indicated for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
The recommended dose for Izervay 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) for up to 12 months.
Mechanism of Action
Izervay (avacincaptad pegol intravitreal solution) is an RNA aptamer, a PEGylated oligonucleotide that binds to and inhibits complement protein C5. By inhibiting C5, avacincaptad pegol may prevent its cleavage to C5a and C5b thus decreasing membrane attack complex (MAC) formation.
Side Effects
Adverse effects associated with the use of Izervay may include, but are not limited to, the following:
- conjunctival hemorrhage
- increased IOP
- blurred vision
- neovascular age-related macular degeneration
Clinical Trial Results
FDA approval was based on the randomized, double-masked, sham-controlled, multicenter Phase 3 GATHER 1 and -2 clinical trials. These trials evaluated the safety and efficacy of monthly 2 mg intravitreal administration of Izervay in patients with GA secondary to AMD. For the first 12 months in both trials, patients were randomized to receive either Izervay 2 mg or sham monthly. There were 286 participants enrolled in GATHER1 and 448 participants enrolled in GATHER2. The primary efficacy endpoints in both pivotal studies were based on GA area measured by fundus autofluorescence at three time points: baseline, month 6, and month 12.
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 Izervay 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.