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| Share Name | Share Symbol | Market | Type |
|---|---|---|---|
| Opthea Limited | ASX:OPT | Australian Stock Exchange | Ordinary Share |
| Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
|---|---|---|---|---|---|---|---|---|---|---|
| 0.00 | 0.00% | 0.635 | 0.63 | 0.65 | 0.66 | 0.625 | 0.635 | 1,330,226 | 07:50:00 |
From Dec 2019 to Dec 2024
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.
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