Outlook Therapeutics Faces Setbacks as FDA Declines Approval for Experimental Eye Disease Drug
Aug 30 (Reuters) – Outlook Therapeutics (OTLK.O) announced on Wednesday that the U.S. Food and Drug Administration (FDA) has declined to approve its experimental eye disease drug. The decision was made in part due to manufacturing issues observed during pre-approval inspections.
As a result of the news, shares of Outlook Therapeutics plummeted by approximately 78% to 30 cents in premarket trading.
This development marks yet another roadblock for the drug’s entry into the market. Last year, Outlook Therapeutics withdrew its application after the FDA requested additional information.
Although the trial for the drug, named ONS-5010, demonstrated satisfactory safety and efficacy, the FDA cited the need for further 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 commonly leads to blurred vision or a blind spot, making it the leading cause of blindness among the elderly.
Outlook Therapeutics had pinned its hopes on the approval of ONS-5010, as it would become the first eye-disease focused version of Roche’s (ROG.S) cancer drug Avastin.
Despite the setback, Outlook Therapeutics is planning to request a meeting with the FDA to address the issues raised. Meanwhile, the European Medicines Agency is set to begin its review process for the drug, with a decision expected in early 2022.
Outlook Therapeutics based its application to the FDA on a late-stage trial, which showed that the drug significantly improved vision in 41.7% of patients who were able to read at least three lines or 15 letters when tested for their ability to distinguish shapes and details.
The company will now need to reassess its strategy and potentially make adjustments to meet the FDA’s requirements.
Reporting by Sriparna Roy in Bengaluru; Editing by Shounak Dasgupta