US FDA refuses to approve Outlook Therapeutics’ eye disease drug

Aug 30 (Reuters) – Outlook Therapeutics (OTLK.O) said on Wednesday that the US Food and Drug Administration had declined to approve its experimental drug for eye diseases, in part because of manufacturing problems noted during pre-approval inspections.

Shares of the company were down about 78% to 30 cents in premarket trading.

The health regulator’s decision marks the latest hurdle for the drug to enter the market, after Outlook Therapeutics last year withdrew its application following a request for additional information from the FDA.

Outlook Therapeutics said Wednesday that while the drug’s trial met safety and efficacy targets, the FDA cited a need for more confirmatory clinical evidence.

ONS-5010 is being developed 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 the patient’s visual field and is the leading cause of blindness among the elderly.

Outlook Therapeutics had pinned its hopes on the drug’s approval as the first version of Roche’s drug focused on eye diseases. (ROG.S) cancer drug Avastin.

Outlook Therapeutics will request a meeting with the FDA to address the issues. The European Medicines Agency is ready to begin its review process for the drug, with a decision date expected early next year.

The company’s application to the FDA was based on a late-stage trial, which showed the drug improved vision in 41.7% of patients who could read at least 3 lines or 15 letters, when tested for its ability to distinguish shapes and details.

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