US FDA declines to approve Outlook Therapeutics' drug for eye condition

Aug 28 (Reuters) - Outlook Therapeutics OTLK.O said on Thursday the U.S. health regulator has declined to approve its experimental drug to treat a type of eye condition, which causes blurred vision, sending its shares slumping nearly 70% before the bell.

The U.S. Food and Drug Administration, in its so-called "complete response letter", cited a lack of substantial evidence of effectiveness in the company's application for the drug, ONS-5010, for treating patients with wet age-related macular degeneration.

This 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.

The FDA's decision marks another setback in Outlook's prolonged efforts to enter the market, following a series of previous challenges. The company had withdrawn its application for the eye disease drug in 2022, after the FDA requested additional information. A year later, the regulator declined to approve the drug, citing manufacturing issues.

"While we are very disappointed with this outcome, we intend to meet with the FDA to receive additional clarity on their requirements" to potentially approve ONS-5010, said CEO Bob Jahr.

The FDA has recommended Outlook to provide additional data on the efficacy to support its application.

The company's resubmitted application was based on the results from a trial that studied the drug compared to Roche's ROG.S treatment Lucentis for improving vision in patients.

In the key trial conducted by Outlook to address some of the FDA's previous concerns, ONS-5010 failed to match Roche's drug at eight weeks.

Other than Lucentis, the already approved and available treatments for wet age-related macular degeneration include Regeneron's REGN.O Eylea and Roche's Vabysmo.

Outlook's drug, under the brand name Lytenava, is approved in the European Union and the UK for the condition.