- Organizations: Astellas
Research
Real-world data support IZERVAY's long-term benefits
OLE trial of the GATHER2 study finds continued GA lesion growth for up to 3.5 years—with earlier intervention offering greater protection of the retinal tissue.Products
FDA approves updated label for IZERVAY to treat GA
Astellas’s avacincaptad pegol now has no limitation on its dosing duration, enabling longer-term administration for patients with GA secondary to AMD.Products
FDA accepts revised sNDA of IZERVAY for GA
Company is requesting inclusion of 24-month data to extend approved dosage for an additional 12 months for both every-month and every-other-month dosing.Products
FDA issues company response letter to Astellas for IZERVAY supplemental NDA
Agency rejects proposal for positive 24-month data to be included in prescribing information; clarifies no issue with safety and benefit/risk of use.
Products
Astellas receives permanent J-code for IZERVAY
FDA-approved therapy is the first and only GA treatment with a statistically significant reduction in the rate of GA progression at the 12-month primary endpoint.Products
Two-year data reported for GATHER2 study on Izervay
Phase 3 study results indicate a continued reduction in GA lesion growth.Products
Positive 24-month data reported in phase 3 study of IZERVAY for GA
Updated safety and efficacy results follow 12-month data from the GATHER1 and GATHER2 trials.
Products
FDA approves Iveric Bio's IZERVAY for GA
Formerly known as Zimura, the formulation is the first C5 inhibitor for treating GA secondary to AMD.
Business
Astellas and 4DMT enter into licensing deal
Agreement gives Astellas access to 4DMT’s proprietary, intravitreal 4100 vector for rare ophthalmic disease targets.
Business
Astellas Pharma acquires Iveric Bio
The $5.9 billion deal includes avacincaptad pegol, an investigational therapy for GA.
Pipeline
FDA accepts NDA, grants priority review for Zimura
Priority Review status was also granted, with a PDUFA target action date set for later this summer.
Pipeline
Opus Genetics acquires rights to Iveric Bio gene therapy candidates
Deal builds on the company’s existing portfolio of AAV-based gene therapies for inherited retinal diseases.
Pipeline
Iveric Bio completes NDA submission of Zimura
Zimura is the first and currently only therapy to receive Breakthrough Therapy Designation for GA secondary to AMD.
Research
Zimura receives FDA breakthrough therapy designation
The FDA has granted Iveric Bio breakthrough designation for avacincaptad pegol (Zimura) to treat geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
Research
Iveric Bio submits part 1 of NDA for GA treatment
Iveric Bio announced the submission of the first part for its new drug application to the FDA for rolling review of avacincaptad pegol (Zimura) for geographic atrophy secondary to age-related macular degeneration.
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