OPT Opthea Limited

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)

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