Outlook Therapeutics announced Friday that federal health regulators have approved its new medication aimed at treating a serious eye condition that can strip older adults of their vision.
The New Jersey-based pharmaceutical company had been seeking approval for Lytenava as a treatment for wet age-related macular degeneration, commonly known as wet AMD. The chronic eye disease can lead to blurred vision and blind spots, and is considered one of the top causes of blindness among the elderly.
Lytenava is an eye-specific formulation of bevacizumab, an antibody-based therapy already approved by the FDA. The drug works by blocking the growth of abnormal blood vessels in the eye — vessels that can damage the retina in people living with wet AMD.
For Outlook Therapeutics, the FDA’s decision represents a major milestone. It is the company’s first product to enter the U.S. commercial market, and it comes after years of navigating a difficult regulatory path that included multiple rejection letters from the FDA. The company successfully appealed to the agency’s Office of New Drugs, which ultimately sided with Outlook on the question of the drug’s effectiveness.
Trading of the company’s shares was paused during afternoon trading following the announcement.
