Outlook Wins FDA Approval After Four Attempts, Entering $13 Trillion Macular Degeneration Market

Outlook Therapeutics secured U.S. Food and Drug Administration (FDA) approval for Lytenava, a treatment for wet age-related macular degeneration, after four attempts, gaining 12 years of market exclusivity. Lytenava is a reformulated ophthalmic version of Roche’s Avastin (active ingredient: bevacizumab) and was approved through an appeals process after three previous rejections. The approval is expected to lead to the launch of an official ophthalmic bevacizumab product that will replace the intravenous formulation currently used off-label in the U.S. market, which is valued at approximately 13 trillion won.