FDA Approves LYTENAVA as First Ophthalmic Bevacizumab for Wet AMD

Outlook Therapeutics has received U.S. Food and Drug Administration (FDA) approval for LYTENAVA™ (bevacizumab-vikg), making it the first FDA-approved ophthalmic formulation of bevacizumab for the treatment of neovascular age-related macular degeneration (wet AMD). The approval provides retina specialists with a purpose-built intravitreal therapy developed specifically for ocular use, replacing reliance on repackaged oncology formulations.

The FDA approval marks a major milestone for Outlook Therapeutics and the retina community. LYTENAVA becomes the first ophthalmic formulation of bevacizumab approved in the United States for wet age-related macular degeneration (AMD), giving physicians access to an FDA-reviewed product manufactured specifically for intravitreal administration. The approval introduces a regulated alternative to compounded intravenous bevacizumab preparations that have long been used off-label in retina practice.

First FDA-Approved Ophthalmic Bevacizumab

For more than two decades, bevacizumab has served as one of the most widely used anti-vascular endothelial growth factor (anti-VEGF) therapies for wet AMD. However, clinicians have relied on repackaged intravenous oncology formulations prepared by compounding pharmacies because no ophthalmic version had previously received FDA approval.

LYTENAVA provides a formulation developed specifically for ocular use and supported by FDA-reviewed manufacturing processes, validated quality standards, approved prescribing information, and ongoing regulatory oversight.

Scientific and Clinical Context

Wet AMD is a chronic retinal disease and one of the leading causes of severe vision loss among older adults worldwide. Because wet AMD requires lifelong intravitreal anti-VEGF injections, manufacturing consistency and product reliability are critical for sustained patient outcomes.

Scientifically, bevacizumab-vikg is a recombinant humanized IgG1 monoclonal antibody that binds vascular endothelial growth factor A (VEGF-A), preventing activation of VEGFR-1 and VEGFR-2 receptors. Inhibiting VEGF-A suppresses abnormal blood vessel growth, vascular leakage, and retinal edema, slowing the disease processes responsible for progressive vision loss.

Regulatory and Market Significance

Approval was based on previously submitted efficacy and safety data reviewed by the FDA following years of clinical development, manufacturing validation, and regulatory evaluation. Outlook Therapeutics expects the product to receive 12 years of Reference Product Exclusivity under the Biologics Price Competition and Innovation Act (BPCIA), providing long-term regulatory protection in the United States.

The therapy has also received centralized marketing authorization from the European Commission and marketing authorization from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for wet AMD. Commercial availability in individual European countries remains subject to national pricing and reimbursement decisions.

According to the company, bevacizumab already accounts for the majority of first-line anti-VEGF treatment in wet AMD. The U.S. retina anti-VEGF market is estimated at approximately $8.5 billion annually, reflecting millions of intravitreal injections performed each year.

Executive Perspective

Chief Executive Officer Bob Jahr said the approval concludes years of work to bring an FDA-approved ophthalmic bevacizumab to retina specialists. He noted that physicians now have access to a product developed specifically for ocular use rather than relying on repackaged intravenous formulations. The company will now focus on expanding patient access, supporting physicians, and establishing LYTENAVA as a new treatment option in retina care.

Firas M. Rahhal, MD, Chairman of Ophthalmology at Good Samaritan Hospital in Los Angeles, said the retina community has long awaited an FDA-approved ophthalmic formulation of bevacizumab for wet AMD and welcomed its availability as an additional treatment option for patients.

Commercial Launch Before Year-End

Outlook Therapeutics plans to make LYTENAVA available to eligible patients in the United States before the end of 2026. The commercial rollout will include reimbursement support, patient assistance programs, physician education, and a specialized retina-focused commercial organization to facilitate adoption in routine clinical practice.

With FDA approval secured, Outlook Therapeutics enters one of the world’s largest ophthalmology markets with the first ophthalmic bevacizumab specifically developed and approved for the treatment of wet AMD, expanding the range of regulated anti-VEGF therapies available to retina specialists.

What This Means for Patients

FDA approval gives patients and retina specialists access to an ophthalmic bevacizumab specifically developed, manufactured, and regulated for intravitreal use. Unlike compounded oncology formulations prepared for off-label ocular administration, LYTENAVA offers standardized manufacturing, FDA-reviewed quality controls, approved labeling, and ongoing regulatory oversight. These features may improve confidence in product consistency and support reliable long-term treatment for patients requiring repeated anti-VEGF therapy.

Reference

Outlook Therapeutics Announces LYTENAVA™ FDA Approval as the First and Only FDA-Approved Ophthalmic Bevacizumab for the Treatment of Wet AMD – Outlook Therapeutics, Inc.