July 24 (Reuters) – Outlook Therapeutics said on Friday the U.S. Food and Drug Administration has approved its drug for a type of eye disease that can cause vision loss.
The New Jersey-based company was seeking approval for Lytenava to treat wet age-related macular degeneration (AMD), a chronic eye disease that can cause blurred vision and blind spots and is a leading cause of blindness among older adults. Its shares closed about 6% higher.
The drug is an ophthalmic formulation of bevacizumab, an FDA-approved antibody therapy that works by inhibiting the growth of abnormal blood vessels that can damage the retina in patients with wet AMD.
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 and a successful appeal to the agency’s Office of New Drugs, which ultimately agreed with the company on the drug’s efficacy.
An estimated 1.2% to 1.3% of Medicare Advantage members have wet AMD, according to the National Institutes of Health data. Patients suffering from this condition often require treatment over many years to preserve vision.
Unlike formulations repackaged from intravenous cancer treatments, Lytenava was specifically developed for intravitreal administration, or injection into the eye, Outlook said.
The company expects Lytenava to qualify for 12 years of U.S. market exclusivity under biologics law and it plans to make the drug available to eligible patients before the end of the year.
The wet AMD market is led by Regeneron’s Eylea and Roche’s Vabysmo and Lucentis.
(Reporting by Kamal Choudhury and Sruthi Narasimha Chari in Bengaluru; Editing by Shilpi Majumdar)
Comments