FDA Approves Class 1 Resubmission of IZERVAY Application for Geographic Atrophy

Astellas Pharma Inc., headquartered in Tokyo, announced that the U.S. Food and Drug Administration (FDA) has accepted a revised supplemental New Drug Application (sNDA) for IZERVAY™ (avacincaptad pegol intravitreal solution). The application pertains to the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). This submission was made on January 6, 2025, in response to the FDA's Complete Response Letter (CRL) issued in November 2024. A meeting between FDA representatives and Astellas in December 2024 paved the way for this Class 1 resubmission, which will undergo a 60-day review period with a target decision date set for February 26, 2025.

Previously, IZERVAY received FDA approval on August 4, 2023, for addressing GA secondary to AMD. The current sNDA is designed to incorporate positive two-year data from the GATHER2 Phase 3 clinical trial into the U.S. Prescribing Information for IZERVAY. Despite these developments, Astellas anticipates that the financial impact on its results for the fiscal year ending March 31, 2025, will be minimal.

IZERVAY, an innovative prescription eye injection, is specifically targeted at treating geographic atrophy, an advanced form of dry AMD. The treatment works by delivering an intravitreal solution directly into the eye, aiming to slow the progression of GA. Patients are advised not to use IZERVAY if they have infections or active swelling in or around the eye, as these conditions could exacerbate side effects.

Serious complications associated with IZERVAY include potential eye infections like endophthalmitis or retinal detachment. Patients experiencing symptoms such as eye pain, increased redness, vision changes, or flashes of light are urged to contact their healthcare provider immediately. Additionally, there is a risk of developing wet AMD while on IZERVAY, which necessitates close monitoring by healthcare professionals.

Temporary increases in eye pressure post-injection are another side effect, underscoring the importance of medical supervision following each treatment. Patients should inform their healthcare provider of any pre-existing conditions such as high eye pressure, glaucoma, or vision issues, as well as any medications they are currently taking. Pregnant or breastfeeding individuals, or those planning to become pregnant, should seek medical advice before undergoing treatment with IZERVAY.

Common side effects of IZERVAY include blood in the white of the eye, increased eye pressure, blurred vision, and the onset of wet AMD. Patients are encouraged to report any persistent or bothersome side effects to their healthcare provider.

Geographic atrophy, associated with AMD, significantly impacts central vision in aging adults, leading to irreversible vision loss as the disease progresses. The GATHER2 clinical trial played a crucial role in evaluating the efficacy and safety of avacincaptad pegol (ACP), with the trial involving 448 participants. The study, a randomized, double-masked, sham-controlled, multicenter Phase 3 trial, met its primary objectives at 12 months. Patients initially treated with ACP were re-randomized in the second year to continue receiving ACP monthly or every other month, while those on a sham treatment continued with the same regimen.

Astellas Pharma Inc. is a global leader in life sciences, focusing on creating transformative therapies across several fields, including oncology, ophthalmology, and immunology. By harnessing innovative science, Astellas aims to deliver substantial value to patients worldwide, particularly in areas with significant unmet medical needs.