Clinical DevelopmentThe determination to pursue a single Phase 3 trial in diabetic macular edema with FDA feedback, combined with pivotal support from the wet age-related macular degeneration program, is viewed as a streamlined path to potential labeling.
Financial PositionResource reallocation has extended the cash runway into 2028, supporting full execution of key programs in wet age-related macular degeneration and early-stage development in diabetic macular edema and cystic fibrosis.
Regulatory And Market OpportunityRegulatory alignment with US and EU regulators on the registrational program for 4D-150 in wet age-related macular degeneration is a key de-risking event, potentially allowing for a broad label and highlighting a large commercial opportunity.