A phase 3 pivotal trial of 4D-150 in Patients with Wet AMD

Status: Planning

Phase of Trial: Phase III

Latest Information Update: 16 Jan 2025

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At a glance

10 Jan 2025 According to a 4D Molecular Therapeutics media release, FDA aligned with proposed single Phase 3 clinical trial being acceptable for the basis of a BLA submission for 4D-150 in DME, based on review of data from SPECTRA and PRISM (wet AMD) clinical trials to date and planned global Phase 3 clinical development program for wet AMD.
10 Jan 2025 According to a 4D Molecular Therapeutics media release, Based on data generated to date for 4D-150 in both the SPECTRA and PRISM clinical trials, FDA is aligned that a single Phase 3 clinical trial, combined with data from the two planned Phase 3 clinical trials in the 4FRONT wet AMD program, would be acceptable as the basis of a BLA submission for 4D-150 in DME.
10 Jan 2025 According to a 4D Molecular Therapeutics media release, 3E10 vg/eye has been selected as the Phase 3 dose.

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