FDA Approves First Bevacizumab Formulation Specifically for Wet AMD

The FDA has approved the first formulation of bevacizumab specifically indicated for neovascular (wet) age-related macular degeneration (nAMD). The approval represents a new treatment option for patients with this vision-threatening condition.

The approval establishes LYTENAVA™ as the first and only FDA-approved ophthalmic formulation of bevacizumab for the treatment of wet AMD in the United States. For the first time, retina specialists and patients have access to an FDA-approved ophthalmic bevacizumab developed specifically for the eye and supported by rigorous clinical evidence, validated manufacturing, approved labeling, comprehensive quality systems, and ongoing FDA regulatory oversight. Additionally, the Company anticipates that the approval will provide LYTENAVATM with 12 years of Reference Product Exclusivity under the BPCIA.

Outlook Therapeutics believes this FDA approval establishes a new benchmark for ophthalmic bevacizumab and positions LYTENAVA™ to become the new FDA-approved standard for bevacizumab therapy in patients with wet AMD. Bevacizumab already accounts for the majority of first-line anti-VEGF treatment in wet AMD, underscoring its important role in retina care.

“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.

Mr. Jahr continued by saying, "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."

“The retina community has been waiting a long time for access to an FDA-approved, ophthalmic formulation of bevacizumab to treat patients suffering from wet AMD in the United States,” added Firas M. Rahhal, MD, Chairman of Ophthalmology at Good Samaritan Hospital, Los Angeles, California. “It is exciting news that LYTENAVA™ will soon be an option for patients suffering from this disease.”

Wet AMD is a chronic, progressive retinal disease and one of the leading causes of severe vision loss among older adults worldwide.2 Patients often require treatment over many years to preserve vision, making manufacturing consistency, product quality, and long-term reliability especially important throughout treatment.

LYTENAVA™ enters one of the world's largest ophthalmology markets. The U.S. anti-VEGF retina market is estimated at approximately $8.5 billion annually, with millions of intravitreal injections administered every year.

The Company is now executing the commercial launch of LYTENAVA™, including expanding reimbursement and patient support access, building an industry-leading, specialized retina commercial organization, supporting physicians nationwide, and establishing LYTENAVA™ as the trusted FDA-approved ophthalmic bevacizumab across the United States.

"FDA approval is the outcome we have been waiting for. Immediate commercial execution is our next mission," added Mr. Jahr. "Everything we do from this point forward is focused on delivering LYTENAVA™ to physicians and patients, expanding access, and building what we believe can become the leading retina care franchise. We are incredibly excited about the opportunity ahead, not only for Outlook Therapeutics, but most importantly for the patients whose vision we strive to protect."

Outlook Therapeutics expects to make LYTENAVA™ available to eligible patients in the United States before year-end. The Company is committed to providing broad patient access support services through comprehensive reimbursement and patient assistance programs designed to help physicians integrate LYTENAVA™ into routine clinical practice for wet AMD.