Outlook Therapeutics Seeks FDA Clarification After Drug Rejection

Outlook Therapeutics US69012T2069

Outlook Therapeutics has formally requested a critical meeting with U.S. regulators, marking its latest effort to secure approval for its ophthalmic drug ONS-5010. The company submitted an application for a Type A Meeting with the Food and Drug Administration (FDA) yesterday. This move is a direct response to the Complete Response Letter the agency issued on December 30, 2025, which rejected the drug's application for treating wet age-related macular degeneration (wet AMD).

• The Drug: ONS-5010, also known as LYTENAVA.
• Current Action: Request for a Type A Meeting with the FDA.
• Approval Status: Already commercially available in the European Union and the United Kingdom since June 2025.
• Market Response: The company's share price gained 11.52% on the day of the announcement.

The primary goal of the requested meeting is to address the FDA's concerns without embarking on entirely new clinical trials. In its late-2025 rejection, the regulatory body cited a lack of substantial evidence for the drug's effectiveness and called for additional confirmatory data.

Outlook Therapeutics management contests the need for new studies, pointing instead to the results from its NORSE TWO Phase 3 trial. According to the company, this study met its primary endpoint, demonstrating a visual acuity gain of 15 letters after twelve months. The forthcoming discussion with the FDA will center on whether this existing clinical data package can sufficiently satisfy the agency's requirements.

A Tale of Two Regulatory Outcomes

The situation highlights a stark regulatory divergence. While LYTENAVA is already on the market in Europe, the FDA remains unconvinced, largely due to the separate NORSE EIGHT study. That trial failed to meet its primary endpoint of non-inferiority at the eight-week mark, despite the company highlighting positive safety and efficacy trends observed through week twelve.

Investors reacted favorably to the company's proactive stance in engaging with the regulator. Following the announcement, shares climbed to approximately $0.4694 in yesterday's trading session. This rebound underscores the stock's sensitivity to regulatory news, coming after a significant decline in late December triggered by the initial FDA rejection.

The outcome of the Type A Meeting will be pivotal. It will determine whether Outlook Therapeutics can bypass additional lengthy clinical studies or if the path to U.S. commercialization will be substantially delayed. The FDA's forthcoming decision on the appropriate approval pathway now stands as the next crucial milestone for the biopharmaceutical firm.

@ boerse-global.de | US69012T2069 OUTLOOK