Opthea OPT-302 Granted Fast Track Designation from FDA
July 06 2021 - 8:00AM
Dow Jones News
By Adriano Marchese
Opthea Ltd. said Tuesday that the U.S. Food and Drug
Administration has granted a Fast Track designation to its OPT-302
treatment for patients with neovascular age-related macular
degeneration.
The clinical-stage biopharmaceutical company--with a focus on
highly prevalent and progressive retinal diseases--said the
designation offers benefits to speed up the OPT-302 phase-three
clinical program and subsequent potential approval process.
"With the Fast Track designation, Opthea is eligible for more
frequent regulatory meetings and communications with the FDA, as
well as a Rolling Review of completed sections of its Biologic Drug
Application which will help expedite the phase-three development
program and subsequent approval review process," the company
said.
Write to Adriano Marchese at adriano.marchese@wsj.com
(END) Dow Jones Newswires
July 06, 2021 07:48 ET (11:48 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
Opthea (ASX:OPT)
Historical Stock Chart
From Nov 2024 to Dec 2024
Opthea (ASX:OPT)
Historical Stock Chart
From Dec 2023 to Dec 2024
