Outlook Therapeutics Inc (NASDAQ:OTLK) stock collapsed, losing some 70% of its value in premarket, after the drug discovery firm’s potential treatment for eye disease was rejected by the US Food and Drug Administration.
The FDA denied the company’s license application for a treatment for wet age-related macular degeneration (AMD), telling the company that it is unable to approve the drug in its current form and that further clinical evidence would be required.
It had passed safety and efficacy endpoints, Outlook said, and the company is seeking a meeting with the FDA ‘as soon as possible’.
“We continue to believe in the public health need to provide the retina community with an FDA-approved bevacizumab treatment option for wet AMD,” Outlook chief executive Russell Trenary said in a statement.
Julia Haller, Outlook board member and ophthalmologist-in-chief at Wills Eye Hospital, meanwhile, added: “The retina community needs an FDA-approved ophthalmic bevacizumab to deliver an alternative targeted on-label treatment for patients with wet AMD.”
In New York, Outlook stock lost $1.09 or 77% in early deals to trade at 31 cents per share.