• organizations:Iveric Bio
Two-year data reported for GATHER2 study on Izervay
Products

Two-year data reported for GATHER2 study on Izervay

Phase 3 study results indicate a continued reduction in GA lesion growth.
 Positive 24-month data reported in phase 3 study of IZERVAY for GA
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.
FDA approves Iveric Bio's IZERVAY for GA
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.
Astellas Pharma acquires Iveric Bio
Business

Astellas Pharma acquires Iveric Bio

The $5.9 billion deal includes avacincaptad pegol, an investigational therapy for GA.
FDA accepts NDA, grants priority review for Zimura
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.
Opus Genetics acquires rights to Iveric Bio gene therapy candidates
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.
Iveric Bio completes NDA submission of Zimura
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.
Zimura receives FDA breakthrough therapy designation
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).
Iveric Bio submits part 1 of NDA for GA treatment
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.
Lots of AMD news — Weekly Glance
Archives

Lots of AMD news — Weekly Glance

Apellis just released data from the phase 3 Derby and OAKS trials.