Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of
'Astellas is committed to bringing innovative treatments to patients with retinal diseases including geographic atrophy. We are pleased with the
The GATHER2 data demonstrated IZERVAY continued to reduce the rate of GA lesion growth in patients with GA secondary to AMD through 2 years versus sham. The treatment benefit with IZERVAY vs. sham was observed as early as 6 months, continued to increase over time through 2 years, and more than doubled over 2 years compared to year 1.
IZERVAY was well tolerated over 2 years in GATHER2, with one case of non-serious intraocular inflammation (IOI) and culture-positive endophthalmitis each, and zero cases of ischemic neuropathy or serious intraocular inflammation, including retinal vasculitis. Over 2 years, the incidence of choroidal neovascularization (CNV) was slightly increased between IZERVAY (11.6%) versus sham (9%).
'GA is a chronic, progressive disease that can lead to irreversible vision loss. Having IZERVAY approved for longer-term use based on the latest safety and efficacy data would be a welcome development for the retina community.'
IZERVAY was approved by the
Astellas has already reflected the impact from this result in its financial forecast for the fiscal year ending
About the GATHER2 Clinical Trial
GATHER2 (NCT04435366) was a randomized, double-masked, sham-controlled, multicenter Phase 3 clinical trial to evaluate the safety and efficacy of intravitreal administration of avacincaptad pegol (ACP) in 448 enrolled patients with GA secondary to AMD. ACP met its primary objective at 12 months, for which patients were randomized to receive either ACP or sham procedure monthly. In year 2 of the study, patients treated with ACP in year 1 were re-randomized to receive either ACP dosed monthly (EM, n=96) or every other month (EOM, n=93); patients who received sham in year 1 continued to receive sham in year 2 (n=203). IZERVAY is continuing to be evaluated in an open-label extension study.
About Geographic Atrophy
Age-related macular degeneration (AMD) is the major cause of moderate and severe loss of central vision in aging adults, affecting both eyes in the majority of patients. The macula is a small area in the central portion of the retina responsible for central vision. As AMD progresses, the loss of retinal cells and the underlying blood vessels in the macula results in marked thinning and/or atrophy of retinal tissue. Geographic atrophy, associated with AMD, leads to further irreversible loss of vision in these patients.
About Astellas
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