Outlook Therapeutics said the FDA has approved LYTENAVA as the first and only FDA-approved ophthalmic bevacizumab for the treatment of wet age-related macular degeneration in the United States. The company said the decision marks a milestone for retina care by giving physicians and patients a bevacizumab formulation developed specifically for the eye, backed by clinical evidence, manufacturing controls and FDA oversight.
LYTENAVA is an ophthalmic formulation of bevacizumab-vikg, also known as bevacizumab gamma in Europe and the UK. Outlook Therapeutics said the approval positions the therapy as a new standard for bevacizumab treatment in wet AMD, a condition that already relies heavily on bevacizumab as a first-line anti-VEGF therapy. The company also expects the product to receive 12 years of reference product exclusivity under the Biologics Price Competition and Innovation Act.
Wet AMD is a chronic and progressive retinal disease and one of the leading causes of severe vision loss among older adults. Outlook Therapeutics said the disease often requires years of treatment, making consistency, product quality and long-term reliability especially important. The company noted that the U.S. retina market is worth about $8.5 billion annually and sees millions of intravitreal injections each year.
Chief Executive Officer Bob Jahr said the approval changes the landscape for bevacizumab in retina care because physicians now have access to a purpose-built ophthalmic formulation for intravitreal use. He said commercial execution is now the company’s next priority, including reimbursement support, patient assistance and a specialized retina sales organization.
Outlook Therapeutics expects to make LYTENAVA available to eligible U.S. patients before year-end. The company said it aims to establish the drug as the trusted FDA-approved ophthalmic bevacizumab for wet AMD.
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