FDA Accepts Revised Avacincaptad Pegol sNDA for Geographic Atrophy

The US Food and Drug Administration (FDA) has accepted the revised supplemental new drug application (sNDA) for avacincaptad pegol intravitreal solution (IZERVAY) to treat geographic atrophy (GA) secondary to age-related macular degeneration (AMD).1

Announced by Astellas Pharma on January 9, 2025, the snDA was accepted on January 6, with the FDA setting a target action date for February 26, 2025. This announcement comes after the agency filed a Complete Response Letter (CRL) for the sNDA in November 2024.2

At the time of the rebuttal, the FDA indicated it could not approve the sNDA based on comments related to a statistical matter on labeling language proposed by the company. No comments were made regarding the safety or benefit-risk profile of avacincaptad pegol for GA secondary to AMD.

“Astellas stands by the clinical profile of [avacincaptad pegol], the only FDA-approved GA treatment that consistently demonstrated statistically significant slowing of GA across two pivotal Phase 3 studies,” Marci English, senior vice president of biopharma and ophthalmology development at Astellas Pharma, explained in an earlier statement.

Avacincaptad pegol was initially approved in August 2023, marking the second available drug to treat GA secondary to AMD.3 A progressive disease underlined by the loss of blood vessels in the macula, leading to thinning and atrophy of retinal tissue, GA can impact vision and mark irreversible loss in eyes with the condition.

Initial approval was based on positive data from the Phase 3 GATHER1 and GATHER2 trials, in which monthly administration of 2 mg avacincaptad pegol was compared with sham for 12 months. Avacincaptad pegol met the primary efficacy endpoint in both pivotal studies, based on a statistically significant reduction in GA area, measured by fundus autofluorescence (FAF) at baseline, 6 months, and 12 months.

Safety data reported in more than 700 patients with GA across both trials showed the most common adverse reactions (≥ 5%) were conjunctival hemorrhage, intraocular pressure, and blurred vision.

At the time of the CRL, Astellas announced the company would seek further information from the FDA and intended to work closely with the agency to address relevant feedback.2

“While this is a disappointment for patients and physicians who rely on [avacincaptad pegol] for the management of a chronic, progressive disease that can lead to irreversible vision loss, Astellas is unwavering in our commitment to the ophthalmology space and will continue to work with the FDA to advance solutions for those suffering from GA,” English added.

The sNDA was refiled following a December 20, 2024, meeting between the FDA and Astellas and has been designated as a Class 1 resubmission, with a 60-day review period.1 This sNDA was intended to include new positive GATHER2 data from the trial at the 2-year mark to the US prescribing information.

References

1. US FDA confirms class 1 resubmission of the Supplemental New Drug Application for IZERVAYTM (avacincaptad Pegol Intravitreal Solution) for geographic atrophy. News | Astellas Pharma Inc. January 9, 2025. Accessed January 9, 2025. https://www.astellas.com/en/news/29636.
2. Iapoce C. FDA issues CRL to Avacincaptad Pegol sNDA for geographic atrophy. HCP Live. November 22, 2024. Accessed January 9, 2025. https://www.hcplive.com/view/fda-issues-crl-to-avacincaptad-pegol-snda-for-geographic-atrophy.
3. Kunzmann K. FDA approves Avacincaptad Pegol for geographic atrophy. HCP Live. August 5, 2023. Accessed January 9, 2025. https://www.hcplive.com/view/fda-approves-avacincaptad-pegol-geographic-atrophy.