The US Food and Drug Administration refuses to approve an eye disease drug produced by Outlook Therapeutics

(Reuters) – Outlook Therapeutics said on Wednesday that the U.S. Food and Drug Administration refused to approve its experimental eye drug, in part because of manufacturing issues noted during pre-approval inspections.

Shares of the company were down about 78% at 30 cents in pre-market trading.

The health regulator’s decision represents the latest roadblock to the drug entering the market, after Outlook Therapeutics last year withdrew its application after the US Food and Drug Administration requested additional information.

Outlook Therapeutics said Wednesday that although the drug’s trial met its safety and efficacy goals, the Food and Drug Administration noted the need for more solid clinical evidence.

ONS-5010 is under development as an injection for the treatment of wet age-related macular degeneration (AMD) and other retinal diseases.

Wet AMD is a chronic eye disorder that causes blurred vision or a blind spot in a patient’s visual field, and is the leading cause of blindness among the elderly.

Outlook Therapeutics had been pinning its hopes on the drug being approved as the first eye-focused version of Roche’s cancer drug Avastin.

Outlook Therapeutics will request a meeting with the US Food and Drug Administration (FDA) to address the issues. The European Medicines Agency is set to begin the review process for the drug, and a decision is expected to be made early next year.

The company’s request to the US Food and Drug Administration (FDA) was based on a late-stage trial, which showed that the drug improved vision in 41.7% of patients who were able to read at least 3 lines, or 15 characters, when their ability to distinguish shapes was tested. and details.

(Reporting by Sribarna Roy in Bengaluru; Editing by Shounak Dasgupta)