Outlook Therapeutics Resubmits Lytenava Biologics License Application to FDA

MT Newswires Live06-01

Outlook Therapeutics (OTLK) has resubmitted its biologics license application for ONS-5010, or Lytenava, for the treatment of neovascular age-related macular degeneration to the US Food and Drug Administration, the company said Monday.

The resubmission comes after the company's successful appeal of the previously announced complete response letter for the drug, where the agency's Office of New Drugs concluded that substantial evidence of effectiveness had been established and no additional trials were required, according to a statement.

The decision directed the Division of Ophthalmology and Office of Specialty Medicine to work with the company to reach an agreement on final product labeling, Outlook said.

A Prescription Drug User Fee Act date and decision is expected within 60 days of the agency's receipt of the resubmission, the company said.

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