Outlook Therapeutics announced on November 10, 2024, that it had laid off 23% of its workforce following disappointing results from its NORSE EIGHT clinical trial. The study, which evaluated the company’s ophthalmic formulation of bevacizumab for wet age-related macular degeneration (AMD), failed to meet the FDA’s prespecified non-inferiority endpoint at week eight. The setback prompted the New Jersey-based biotech to initiate cost-cutting measures aimed at extending its cash runway and preparing for a revised regulatory strategy.

The company stated that while the trial did not meet its primary endpoint, preliminary data showed signs of biologic activity and some improvement in vision, along with a favorable safety profile. Outlook plans to resubmit its biologics license application in early 2025, banking on additional data expected in January to support its case.

The layoffs affected five employees, reducing Outlook’s headcount to approximately 16. The company estimates the move will save $1.4 million annually, excluding severance and restructuring costs. This marks the second major setback for Outlook in 2024, following earlier delays in its European commercialization plans.

Investors responded cautiously, with shares dipping slightly amid broader concerns about the viability of biosimilar ophthalmic therapies in a market dominated by entrenched players like Regeneron and Roche. Analysts say Outlook’s future hinges on its ability to demonstrate meaningful differentiation and secure FDA approval in a competitive and highly regulated space.