Astellas’ Izervay receives marketing authorization in Korea

Slows progression of geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD).

Indicated for patients with foveal center sparing...Accurate early diagnosis and reimbursement key to access

Patients with late-stage dry age-related macular degeneration (AMD) who were at risk for blindness with no effective treatment option now have their first therapeutic alternative available in Korea.

The Ministry of Food and Drug Safety (MFDS) approved Astellas Pharma Korea’s Izervay (avacincaptad pegol sodicum) on the 23rd as a new drug for the treatment of geographic atrophy (GA).

The approval carries significant clinical implications, as it extends Korea’s retinal disease treatment landscape, which has largely centered on neovascular (wet) AMD, to an advanced form of dry AMD.

Selective C5 inhibition…slows loss of central vision

Izervay is an intravitreal PEGylated RNA aptamer that binds to and inhibits C5, a key protein in the complement cascade. By blocking the formation of the membrane attack complex (MAC) resulting from excessive complement activation, it slows the irreversible loss of retinal pigment epithelium (RPE) and photoreceptor cells.

The approved indication is “to slow the progression of geographic atrophy secondary to age-related macular degeneration in patients with foveal center sparing.”

The recommended dose is 2 mg (0.1 mL) per administration. Izervay is administered by intravitreal injection once monthly for the first 12 months after treatment initiation, followed by once every 2 months thereafter. The less frequent dosing schedule from the second year is expected to significantly reduce the burden of intraocular injections and clinic visits for elderly patients.

In the global Phase III GATHER1 and GATHER2 trials, Izervay significantly reduced the rate of GA lesion growth by approximately 14% to 35% versus sham treatment at 12 months. Although it cannot regenerate retinal cells that have already been lost, the treatment is intended to preserve the fovea, which is critical to central vision and everyday activities such as reading and driving, for as long as possible and thereby delay vision loss as long as possible.

The global GA treatment market is currently led by two therapies -- Apellis’ Syfovre (pegcetacoplan) and Astellas’ Izervay.

Syfovre, a C3 inhibitor, reached the market first, but rare cases of serious ischemic events, including occlusive retinal vasculitis, emerged following its launch. Izervay, which targets C5 further downstream in the complement pathway, has meanwhile been associated with a markedly lower reported rate of serious retinal vasculitis and has drawn attention for its better safety profile.

In Korea, Izervay has secured MFDS approval ahead of Syfovre, giving Astellas Pharma Korea first-mover status in the domestic GA market. Izervay has also continued to post strong overseas growth and is drawing attention as a potential blockbuster, with annual global sales exceeding KRW 2 trillion.

Precise diagnosis ‘before foveal involvement’ essential...reimbursement remains key challenge

Experts have welcomed the arrival of the new treatment while emphasizing the importance of accurately identifying eligible patients.

Under the approved indication, treatment is strictly limited to patients whose foveal center remains spared, as confirmed by fundus autofluorescence (FAF) and optical coherence tomography (OCT). Clinical analyses found no clear treatment benefit once lesions had already reached the foveal center, while a trend toward a higher long-term risk of vision loss versus sham was observed in such patients. Close monitoring is also required for choroidal neovascularization, or conversion to wet AMD, which can occur with complement inhibition, as well as transient increases in intraocular pressure following injection.

The biggest hurdle to Izervay’s broader patient access will be national health insurance reimbursement. As a high-cost biologic, Izervay is expected to carry a substantial annual treatment cost, making timely reimbursement through pricing negotiations with the Health Insurance Review and Assessment Service (HIRA) and potential use of a risk-sharing agreement (RSA) a key next step.

A retinal specialist said, “Patients with late-stage dry AMD have long represented a major area of unmet medical need, with no treatment available as they watched their vision deteriorate. Izervay’s approval has opened a tangible treatment pathway to preserve central vision, which now needs to be followed by an effective early-diagnosis framework and timely reimbursement.”