FDA approves Outlook Therapeutics’ Lytenava as first ophthalmic Bevacizumab for wet AMD

USA—The US Food and Drug Administration (FDA) has approved Outlook Therapeutics’ Lytenava (bevacizumab-vikg) to treat wet age-related macular degeneration (AMD), a chronic eye disease that can cause severe vision loss.

The approval makes Lytenava the first FDA-approved ophthalmic formulation of bevacizumab in the United States and marks Outlook Therapeutics’ entry into the US commercial market.

The New Jersey-based company developed the drug specifically for intravitreal administration to patients with wet AMD.

Wet AMD occurs when abnormal blood vessels grow and leak fluid or blood into the retina, potentially causing blurred or distorted vision and blind spots.

It is also a leading cause of blindness among older adults.

Lytenava contains bevacizumab, an anti-vascular endothelial growth factor (anti-VEGF) antibody that inhibits the growth of abnormal blood vessels that can damage the retina.

Although physicians have widely used bevacizumab off-label to treat retinal diseases because of its comparatively low cost, the FDA had not previously approved an ophthalmic formulation of the drug.

According to Outlook Therapeutics, Lytenava will provide retina specialists with a bevacizumab product specifically developed for intravitreal use rather than repackaged formulations originally manufactured for intravenous administration.

The company said the product is supported by clinical data, validated manufacturing processes, FDA-approved labeling and continued regulatory oversight.

Approval follows regulatory setbacks

The approval follows a lengthy regulatory process that included three FDA Complete Response Letters (CRLs) dating back to 2023.

Most recently, the FDA issued a CRL on December 30, 2025, regarding Outlook’s biologics license application (BLA) for ONS-5010/Lytenava.

However, Outlook successfully appealed the decision through a Formal Dispute Resolution (FDR) process.

Two months before the latest approval, the FDA’s Office of New Drugs (OND) granted the company’s appeal and concluded that Outlook had established “substantial evidence of effectiveness” for Lytenava in treating wet AMD.

The decision allowed the company to resubmit its BLA and ultimately paved the way for the FDA approval.

“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,” said Bob Jahr, chief executive officer of Outlook Therapeutics.

“Lytenava fundamentally changes that landscape.”

Outlook Therapeutics also expects Lytenava to receive 12 years of reference product exclusivity under the Biologics Price Competition and Innovation Act.

US commercial launch planned

Following the approval, Outlook Therapeutics is preparing to launch Lytenava in the US by expanding reimbursement and patient support programs, strengthening its retina-focused commercial organization and engaging physicians across the country.

The company expects Lytenava to become available to eligible US patients before the end of 2026.

Meanwhile, the product is already authorized in Europe and the United Kingdom under the Lytenava brand.