Outlook Therapeutics has secured a landmark regulatory victory after the US FDA approved LYTENAVA (bevacizumab-vikg) for treatment of neovascular age-related macular degeneration (nAMD), commonly known as wet AMD.

 

The approval makes LYTENAVA the first and only FDA-approved ophthalmic formulation of bevacizumab for wet AMD in the United States, opening the door to a purpose-built eye therapy backed by clinical evaluation, validated manufacturing standards, approved labeling, and ongoing FDA oversight.

 

The company said it expects the approval to provide LYTENAVA with 12 years of Reference Product Exclusivity under the Biologics Price Competition and Innovation Act (BPCIA), while positioning the therapy to compete in the approximately $8.5 billion U.S. retina market.

 

For more than two decades, bevacizumab has been widely used in retina care despite the absence of an FDA-approved ophthalmic formulation. Outlook Therapeutics said LYTENAVA is designed to address that gap by providing a formulation specifically developed for intravitreal administration.

 

“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. Rather than relying on repackaged formulations originally intended for intravenous use, physicians now have access to a purpose-built ophthalmic formulation of bevacizumab designed specifically for intravitreal administration that delivers the manufacturing consistency, product quality, and regulatory oversight patients deserve.” said Bob Jahr, Chief Executive Officer of Outlook Therapeutics.

 

Jahr added: "Today's approval represents a defining moment for Outlook Therapeutics and, more importantly, for the physicians and patients we have been working to serve. With the approval of LYTENAVA, physicians now have access to the first FDA-approved ophthalmic bevacizumab developed specifically for the eye. 

 

"We believe this approval has the potential to meaningfully advance patient care and establish LYTENAVA as an important new treatment option for retina specialists and wet AMD patients across the United States."