A Randomized, Double Masked, Active Controlled Phase III Study of the Efficacy, Safety, and Tolerability of Repeated Doses of Intravitreal VEGF Trap in Subjects With Neovascular Age-Related Macular Degeneration
Phase of Trial: Phase III
Latest Information Update: 11 Dec 2017
At a glance
- Drugs Aflibercept (Primary) ; Ranibizumab
- Indications Choroidal neovascularisation; Wet age-related macular degeneration
- Focus Registrational; Therapeutic Use
- Acronyms VIEW-1
- Sponsors Regeneron Pharmaceuticals
- 11 Dec 2017 According to Regeneron Pharmaceuticals media release, the U.S. Food and Drug Administration (FDA) has accepted Company's supplemental Biologics License Application (sBLA) for a EYLEA (aflibercept) Injection in patients with wet age-related macular degeneration (wet AMD) based on physician's assessment. Under the Prescription Drug User Fee Act (PDUFA), the goal for a standard review of an sBLA is ten months from submission for a target action date of August 11, 2018.
- 01 Apr 2015 According to Bayer media release, based on data from this trial and the SIGHT study (see profile 700255430) as well as those of the previous VIEW 2 (see profile 700238599) trial, Bayer HealthCare has submitted an application for marketing authorization of aflibercept solution for injection for the treatment of patients with wet AMD to the China Food and Drug Administration.
- 12 Nov 2013 Bayer received approval from Health Canada for aflibercept based on the results of this study, according to a company media release.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History