This approval marks LYTENAVA™ as the first FDA-approved ophthalmic formulation of bevacizumab specifically for wet AMD in the United States.
With this development, retina specialists and patients now have access to a bevacizumab ophthalmic solution that is backed by rigorous clinical evidence and validated manufacturing processes.
Stay ahead of biotech and pharmaceutical market-moving events with the CatalystPICR FDA Calendar.
The approval is expected to provide LYTENAVA™ with 12 years of Reference Product Exclusivity under the Biologics Price Competition and Innovation Act.
Wet AMD is a chronic and progressive retinal disease, recognized as a leading cause of severe vision loss among older adults globally.
Bob Jahr, Chief Executive Officer of Outlook Therapeutics, commented, “For more than two decades, bevacizumab has served as one of the most widely utilized anti-VEGF therapies in retina care despite the absence of an FDA-approved ophthalmic formulation. LYTENAVA™ fundamentally changes that landscape.”
