FDA Approves LYTENAVA for Wet Age-Related Macular Degeneration

Outlook Therapeutics has secured U.S. Food and Drug Administration (FDA) approval for LYTENAVA™ (bevacizumab-vikg), making it the first and only FDA-approved ophthalmic formulation of bevacizumab for the treatment of neovascular age-related macular degeneration (nAMD), also known as wet AMD.

The approval marks a significant milestone for both the company and retina specialists, who have long relied on repackaged bevacizumab originally developed for intravenous cancer treatment to manage wet AMD. LYTENAVA is the first version of the drug specifically formulated for use in the eye and manufactured under FDA-approved quality and regulatory standards.

Outlook Therapeutics said the approval positions LYTENAVA as a new benchmark for ophthalmic bevacizumab therapy in the United States. The company also expects the product to receive 12 years of Reference Product Exclusivity under the Biologics Price Competition and Innovation Act (BPCIA).

Wet AMD is a chronic and progressive retinal disease that is one of the leading causes of severe vision loss among older adults. Patients often require repeated anti-VEGF injections over several years to preserve their vision, making product quality, manufacturing consistency, and regulatory oversight important considerations for long-term treatment.

Bevacizumab is already one of the most widely used first-line anti-VEGF therapies in retina care. However, until now, physicians have relied on compounded or repackaged formulations because no ophthalmic version had received FDA approval.

Bob Jahr, Chief Executive Officer of Outlook Therapeutics, said the approval changes the treatment landscape by giving physicians access to an ophthalmic bevacizumab developed specifically for intravitreal injection rather than a reformulated intravenous medicine. He said the product offers the manufacturing consistency, quality controls, and regulatory oversight expected from an FDA-approved therapy.

Jahr described the approval as a defining moment for the company and for patients living with wet AMD. He added that Outlook Therapeutics believes LYTENAVA has the potential to become an important treatment option for retina specialists while helping improve patient care across the United States.

Firas M. Rahhal, M.D., Chairman of Ophthalmology at Good Samaritan Hospital in Los Angeles, welcomed the approval, saying retina specialists have been waiting many years for an FDA-approved ophthalmic formulation of bevacizumab. He noted that LYTENAVA will soon provide physicians with another treatment option for patients affected by wet AMD.

The approval gives Outlook Therapeutics entry into the U.S. anti-VEGF retina market, which the company estimates is worth approximately $8.5 billion annually. Millions of intravitreal injections are administered each year, highlighting the significant commercial opportunity for the newly approved therapy.

The company has already begun preparations for the commercial launch of LYTENAVA, including expanding reimbursement support, developing patient assistance programs, building a specialized retina-focused commercial team, and working with physicians to integrate the treatment into routine clinical practice.

Outlook Therapeutics expects LYTENAVA to become available to eligible patients in the United States before the end of the year. The company said its immediate focus is on broadening patient access and supporting retina specialists as it launches what it hopes will become a leading franchise in retinal disease treatment.