#United States #Tokyo #Astellas Pharma #IZERVAY #Geographic Atrophy

FDA Approval Marks Milestone for IZERVAY™

On January 6, 2025, Astellas Pharma Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted its resubmitted Supplemental New Drug Application (sNDA) for IZERVAY™ (avacincaptad pegol intravitreal solution). This acceptance comes after the agency's Complete Response Letter (CRL) issued in November 2024, and designates the application as a Class 1 resubmission, which allows for a 60-day review period. The target action date has been set for February 26, 2025.

IZERVAY was originally approved by the FDA on August 4, 2023, for treating geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The current sNDA aims to include positive two-year data derived from the GATHER2 Phase 3 clinical trial, enhancing the prescribing information for healthcare professionals and patients alike.

Background on Geographic Atrophy and AMD

Geographic atrophy represents the advanced stage of dry AMD, which is a leading cause of significant central vision loss in older adults. The condition involves the progressive deterioration of retinal cells within the macula, crucial for detailed central vision. As AMD advances, patients experience a gradual decrease in visual acuity and an increase in the area of atrophy, leading to irreversible vision loss.

Clinical Insights from the GATHER2 Trial

The GATHER2 trial, a key clinical study involving 448 patients with GA due to AMD, was randomized, double-masked, and sham-controlled. It commenced with participants receiving either avacincaptad pegol or a sham treatment over a twelve-month period. The results showcased that patients treated with the drug met primary efficacy endpoints, paving the way for further evaluations.
In the second year of the trial, participants who had received the actual treatment were re-randomized. This ongoing evaluation will continue to provide data to support the drug’s long-term efficacy and safety profile.

Astellas and the Future of IZERVAY

In light of the recent submission and ongoing trials, Astellas anticipates that the impact on its financial outcomes for the fiscal year ending March 31, 2025, will be minimal. The company maintains a strong commitment to addressing unmet medical needs through innovative therapies across various disease states, including ophthalmology.
As a foremost life sciences entity, Astellas is dedicated to transforming science into valuable healthcare solutions. Further details about their R&D efforts can be found at Astellas' official website.

Important Safety Information

While the efficacy of IZERVAY is promising, it is critical to note the associated risks. Potential severe side effects include eye infections, retinal detachments, and increased eye pressure following administration. Patients are advised to refrain from activities such as driving or operating machinery until their vision stabilizes after treatment.

In summary, the FDA's acceptance of Astellas Pharma's sNDA for IZERVAY marks a significant step towards providing effective treatment for patients suffering from geographic atrophy due to AMD. As the review process unfolds, stakeholders will be keenly observing the outcomes of the February assessment and its implications for those afflicted by this debilitating condition.