Shares of drugmaker Outlook Therapeutics OTLK.O rose 18% to $1.56.
The U.S. FDA approved OTLK's drug, Lytenava, for wet age-related macular degeneration (AMD).
AMD is a chronic eye disease that can cause blurred vision and blind spots and is a leading cause of blindness among older adults.
The approval marks Outlook's first commercial entry into the U.S. market and validates a years-long regulatory effort that included multiple FDA rejection letters.
Including the session's move, shares are down 23% year to date.